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senior clinical research associate level dependent on experience

CTI Clinical Trial and Consulting

<div><div><b>Senior Clinical Research Associate (</b><b>home based</b><b>) (Level dependent on experience)</b></div>
<div><br>
To help support the unique job functions of our CRAs, we have a dedicated training department that offers ongoing therapeutic training sessions from our world-class medical directors, and an experienced and supportive management team that is there to offer continual guidance. Additionally, all CRAs are able keep their hotel points and airline miles and are offered a home office allowance.<br>
<br>
Maintaining our company culture across all regions, and especially with our remote employees, is incredibly important to our overall success. To do so, we have weekly all-staff meetings in which each department can provide an update on a study or milestone that they have achieved. Each employee also has the opportunity join one of our CTI Cares committees that not only help support our culture, but also focus on our various philanthropic efforts.<br>
<br>
<b>What You'll Do</b></div>
<ul><li>Manages investigative site activity for multiple protocols / indications and provides ongoing updates of site status to Project Manager / sponsor.</li>
<li>Creates and implements subject enrollment strategies for assigned investigative sites.</li>
<li>Conducts study site visits (pre-study, initiation, monitoring, and close-out) and completes site visit deliverables within given timelines in the Monitoring Plan.</li>
<li>Ensures proper storage, dispensation, and accountability of all investigational product(s) and trial-related material.</li>
<li>Maintains tracking records for assigned sites including tracking of subject status, subject case report form (CRF) retrieval / source document review (SCV), regulatory documents, and investigational product.</li>
<li>Participates in development of CRFs and other study related documents</li>
</ul><div><b>What You Bring</b></div>
<ul><li>Bachelor&rsquo;s or Master&rsquo;s Degree in allied health fields, such as nursing, pharmacy, or health / natural science, or</li>
<li>RN with Associate&rsquo;s Degree or 3-year Nursing Diploma with at least 2 years of clinical nursing experience</li>
</ul><div><b>Why CTI?</b>
<div>At CTI, we recognize that our people are what make our company successful. Our work moves medicine forward.</div>
<div>For that reason, we treat our team members with the respect they deserve, and our numbers show it:</div>
<ul><li>We support career progression &ndash; We believe in promoting from within and we have a structured mentoring program and program for recent graduates to provide the support employees need to move forward</li>
<li>We value education and training &ndash; We provide tuition assistance, partner with universities and colleges to create programs in our field, and have a dedicated training department</li>
<li>We value our people - We have never had a layoff in our three decade history and we guaranteed full pay for our employees during the COVID-19 shut-down regardless of the number of hours worked. We support a work-life balance and the importance of time with family by offering generous vacation time, a hybrid work from home schedule, and paid parental leave.</li>
<li>Our culture is unparalleled &ndash; We've received multiple awards recognizing CTI as one of the best places to work in the greater Cincinnati area, as well as one of the top CROs in the industry</li>
<li>We think globally and act locally &ndash; With employees across 60 countries, we have global reach but maintain culture and connections to the local communities in which we work. Our CTI Cares Committees are dedicated to ensuring the CTI culture and values translate around the world.</li>
<li>We are looking toward the future &ndash; We have had a consistent double-digit growth rate over the last decade, invest in cutting-edge technology, and pride ourselves on our average annual retention rate of 95%, which is much higher than many other CROs</li>
<li>Our work makes a difference &ndash; We focus our work on treatments for chronically and critically-ill patients, who are depending on us to bring these life-changing therapies to market</li></ul></div></div>

Senior Clinical Research Associate (level dependent on experience)

Ivy Tech Community College

<div>General Purpose and Scope of Position:<br>
<br>
Provides executive-level administrative support for the academic affairs and student affairs and serves as the primary scheduler to the Provost and Senior Vice President for Academic Affairs; Senior Vice President for Student Affairs; Vice President for K-14 and Strategic Initiatives; Vice President for Recruitment and Enrollment Management; Vice President for Academic Affairs; Vice President for Student Success and Retention Strategy; and Vice President for Academic Systems and Completion Strategy. Handles details of highly confidential and critical information and must function efficiently and effectively in a fast-paced professional environment. Independently manages multiple tasks and projects with competing priorities and deadlines; screens and prioritizes communications from external and internal sources; organizes and maintains administrative processes. Maintains a professional work environment and serves as principle contact with the College and external constituents from local, state, and national agencies, councils, and other organizations. Completes assigned special projects and tasks with minimal supervision.<div></div><div><b>
Major Responsibilities:</b></div><div></div><div><b>
Scheduling &amp; Communications</b></div><ul><li><div>
Manages internal and external contacts for the Provost and team, proactively understanding preferences for scheduling, priority contacts, and keeping track of periodic communication needed for priority contacts.</div></li><li><div>
Schedules a high volume of appointments and meetings, accurately maintaining all scheduling software and calendars. Duties include research, agenda preparation, and content development.</div></li><li><div>
Schedules and coordinates college travel and associated arrangements, maintaining appropriate documentation.</div></li><li><div>
Assists executive leadership with timely and effective communications regarding key departmental information and updates.</div></li><li><div>
Responsible for routine department communication, including preparing and responding to emails, electronic and written correspondence, and calls.</div></li></ul><div></div><div><b>
Meeting &amp; Event Planning</b></div><ul><li><div>
Assists with State Board of Trustees communications, engagement, and support.</div></li><li><div>
Coordinates on and off-campus meetings to include appropriate room accommodations, guest parking, catered luncheons and refreshments, and audio/visual equipment as needed.</div></li><li><div>
Hosts and facilitates virtual meetings and workshops on behalf of the Provost Office and coordinates all event logistics, speakers, and communications leading up to the event and post-event evaluations.</div></li><li><div>
Provides meeting planning and logistics support for statewide academic affairs, K-14, and student affairs meetings.</div></li><li><div>
Prepares presentations for internal and external groups and ensures production of professional-quality reports and handouts.</div></li><li><div>
Performs first-level research, including preparation of report summaries, and gathers information to assist in the preparation of reports and presentations, including materials for the Academic &amp; Student Experience committee of the Board.</div></li><li><div>
Develops and manages detailed project schedules and work plans.</div></li><li><div>
Takes and distributes meeting minutes/notes.</div></li></ul><div></div><div><b>
Office Management &amp; Operations</b></div><ul><li><div>
Greeting and directing guests; maintaining calendars and scheduling meetings and appointments; and screening calls and visitors.</div></li><li><div>
Supports internal workflows within the Provost Office to ensure efficient operations and help identify opportunities to improve processes and overall organizational effectiveness.</div></li><li><div>
Screens and distributes mail for the department as required.</div></li><li><div>
Maintains accurate electronic and hard copy department files.</div></li><li><div>
Develops and maintains a system that alerts to deadlines on incoming requests or events.</div></li><li><div>
Develops and manages detailed project schedules and work plans.</div></li><li><div>
Provides project updates on a consistent basis to various stakeholders about strategy, adjustments, and progress.</div></li><li><div>
Supports the procurement and payment processing activities for the office.</div></li><li><div>
Supports other positions within academic and student affairs as assigned.</div></li><li><div>
Completes special projects as assigned.</div></li></ul><div></div><div>
This is not to be construed as an exhaustive list. Other duties logically associated with this position may be assigned. All responsibilities will be conducted within the parameters of the Family Educational Rights and Privacy Act (FERPA), other applicable regulatory requirements, and professional standards.</div><div></div><div><b>
Supervision Received:</b> This position is supervised by the Provost and Senior Vice President for Academic Affairs, with indirect supervision from the Senior Vice President of Student Affairs.</div><div></div><div><b>
Supervision Given:</b> None</div><div><b>
Salary Range: $50,000-55,000</b></div><div></div><div><b>
Education and Experience:</b></div><ul><li><div>
Associate degree required, Bachelor&rsquo;s degree preferred.</div></li><li><div>
Minimum of two years&rsquo; experience supporting senior-level/executive administrators required.</div></li><li><div>
Proficient computer skills, including Microsoft Word, Excel, and PowerPoint, required. Must have the ability to learn and use applicable software (e.g., student services systems and reporting software).</div></li><li><div>
Excellent oral, written, and interpersonal communication skills required.</div></li><li><div>
Must exhibit professional demeanor, initiative, and good judgment, be able to work well under pressure and independently.</div></li><li><div>
Must positively anticipate or react to frequently changing priorities, and maintain confidentiality on all matters related to the College, its staff, faculty, students, and trustees.</div></li><li><div>
Must demonstrate professional demeanor and ability to defuse emotional situations in a calm manner.</div></li><li><div>
Must have the willingness and ability to occasionally travel on College business, be willing to work occasional extended hours, and be willing and capable of communication outside of normal work hours.</div></li><li><div>
Must demonstrate ability to promote an inclusive environment that reflects the broad diversity and backgrounds represented by our students and employees, and in which every individual feels respected and valued.</div></li></ul><div></div><div>
Ivy Tech is committed to supporting the well-being, growth, and financial security of our full-time faculty and staff. Our comprehensive benefits package includes:</div><div><b><br>
Health &amp; Wellness</b></div><ul><li><div>
Multiple medical plan options paired with a Health Savings Account with a generous employer contribution</div></li><li><div>
Dental plan with no-cost preventive services and coverage for orthodontia</div></li><li><div>
Vision plan with low-cost exams and allowances for glasses or contact lenses</div></li><li><div>
Employee Assistance Program offering no-cost confidential counseling sessions, legal consultations, financial planning consultations, and other resources</div></li><li><div>
Wellness program with opportunities to earn $250 in Wellness Rewards</div></li><li><div>
Flexible Spending Accounts for healthcare (limited purpose) and dependent care</div></li></ul><div></div><div><b>
Retirement &amp; Financial Security</b></div><ul><li><div>
10% employer retirement contribution, fully vested after two years</div></li><li><div>
Basic life insurance equal to annual salary paid by the College, with optional supplemental coverage</div></li><li><div>
Short-term and long-term disability benefits</div></li></ul><div></div><div><b>
Educational Benefits</b></div><ul><li><div>
Fee remission for employees, spouses, and dependent children</div></li><li><div>
Tuition assistance for undergraduate, graduate, and doctoral programs</div></li><li><div>
Paid professional development opportunities</div></li></ul><div></div><div><b>
Work‑Life Balance</b></div><ul><li><div>
Generous paid time off, including vacation, sick leave, holidays, and winter recess</div></li><li><div>
Flexible work arrangements where available</div></li><li><div>
Paid childbirth recovery leave (8 weeks)</div></li><li><div>
Paid parental leave (4 weeks)</div></li></ul><div></div><div><b>
Additional Perks</b></div><ul><li><div>
Eligibility for Public Service Loan Forgiveness</div></li><li><div>
Additional discounts on gym memberships, transportation, and various retail services</div></li></ul><div></div><div>
Ivy Tech is proud to offer benefits that support your health, your family, and your future&mdash;because when our employees thrive, our students and communities thrive too. For more information on Ivy Tech Benefits, visit <div>https://careers.ivytech.edu/benefits</div>.</div><div></div><div>
Note: Employees who re-hire with the College within 180 days of leaving a full-time position with the College may be eligible for additional benefits depending on their bridged seniority date.</div><div><br>
Ivy Tech Community College is an accredited, equal opportunity/affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, ethnicity, national origin, marital status, religion, sex, gender, sexual orientation, gender identity, disability, age or veteran status. As required by Title IX of the Education Amendments of 1972, Ivy Tech Community College does not discriminate on the basis of sex, including sexual harassment in its educational programs and activities, including employment and admissions. Questions specific to Title IX may be referred to the College&rsquo;s Title IX Coordinator or to the US Department of Education Office of Civil Rights.</div></div>

Executive Coordinator for Academic and Student Affairs

Indiana University

<div><p><b>Department</b></p><p>
GASTROENTEROLOGY (IN-GAST-IUINA)</p><p><b>
Department Information</b></p><p>
We are seeking a Clinical Research Coordinator to help continue our distinguished tradition of excellence in patient care, innovation, and education in the Division of Gastroenterology and Hepatology. We are consistently ranked by United States (U.S.) News and World Report as a top program nationally and are 1 of the largest divisions in the country with wide-ranging and reaching clinical and research expertise.</p><p><b>
Job Summary</b></p><p>
The Clinical Research Coordinator will be responsible for independently conducting investigator-initiated, grant-funded, and clinical drug trials. Some duties may include study start-up and close-out, patient recruitment, patient scheduling, data entry, equipment set-up and ordering, corresponding with industry sponsors, hosting site monitoring visits, and resolving queries. This is a patient-facing role with associated administrative duties in an office environment and will be joining our Endoscopic Retrograde Cholangiopancreatography (ERCP) team.</p><p>
General Responsibilities</p><ul><li>
Initiates and conducts protocol review, evaluations, study design, and risk assessments of clinical research studies</li><li>
Participates in study budget negotiations and reconciles study budget accounts</li><li>
Develops informational materials for recruitment of subjects</li><li>
Monitors enrollment goals and modifies recruitment strategy as needed</li><li>
Oversees and ensures compliance with regulations, including organizing electronic files and/or filing regulatory documents appropriately</li><li>
Prepares and submits Institutional Review Board (IRB) documents (i.e., Informed Consent, advertisement, protocol and protocol summary)</li><li>
Prepares regulatory documents for sponsor</li><li>
Identifies and selects potential subjects by reviewing existing protected health information, screening subjects, and conducting interviews</li><li>
Performs subject interviews and assessments for data required by protocol(s)</li><li>
Follows up on study documentation with necessary stakeholders (healthcare providers, study participants, laboratory personnel, etc.)</li><li>
Reviews incoming subject adverse event (SAE) information, assists Principal Investigator (PI) in making submission determination of SAEs, and follows up to determine resolution of adverse events</li><li>
Conducts study-related non-medical/behavioral assessments/interventions as well as study procedures/interventions (appropriate licensure may apply)</li><li>
Records, documents, and reports protocol deviations and trial changes to PI and sub-investigators</li><li>
Stays up to date with knowledge of regulatory affairs and/or issues</li></ul><p><b>
Qualifications</b></p><p><i>
Combinations of related education and experience may be considered. Education beyond the minimum required may be substituted for work experience. Work experience beyond the minimum required may be substituted for education.
</i></p><p></p><p>EDUCATION / WORK EXPERIENCE</p><p><b>
Required</b></p><ul><li>
Bachelor's degree in science or a health-related field and 2 years of clinical research experience; <b>OR</b></li><li>
Associate's degree in science or a health-related field and 3 years of clinical research experience</li></ul><p>
LICENSES AND CERTIFICATES</p><p><b>
Preferred</b></p><ul><li>
Society of Clinical Research Associates (SOCRA)/Association of Clinical Research Professionals (ACRP) Clinical Research Certification upon date of hire</li></ul><p>
SKILLS</p><p><b>
Required</b></p><ul><li>
Demonstrates analytical skills</li><li>
Ability to simultaneously handle multiple priorities</li><li>
Possesses strong technical aptitude</li><li>
Demonstrates a high commitment to quality</li><li>
Excellent organizational skills</li></ul><p><b>
Working Conditions / Demands</b></p><p>
The role regularly requires the ability to effectively communicate. The role frequently requires the ability to move about the work environment and to position oneself to operate laboratory equipment effectively. The role requires the ability to move objects weighing up to 25 pounds and will occasionally work near moving mechanical parts. The person in this role must be able to perform the essential functions with or without an accommodation.</p><p><b>
Work Location</b></p><p>
University Hospital</p><p>
Indianapolis, Indiana</p><p><b>
Advertised Salary</b></p><p>
$60,000 - $65,790 per year based on experience and internal equity within the division.
</p><p><b>Benefits Overview</b></p><p>
For full-time staff employees, Indiana University offers a wide array of benefits including:</p><ul><li>
Comprehensive medical and dental insurance</li><li>
Health savings account with generous IU contributions</li><li>
Healthcare and dependent care flexible spending accounts</li><li>
Basic group life insurance paid by IU</li><li>
Voluntary supplemental life, long-term disability, critical illness, and supplemental accidental death and dismemberment insurance</li><li>
Base retirement plan with generous IU contributions, subject to vesting</li><li>
Voluntary supplemental retirement plan options</li><li>
Tuition subsidy for employees and family members taking IU courses</li><li>
10 paid holidays plus a paid winter break each year</li><li>
Generous paid time off plans</li><li>
Paid leave for new parents and IU-sponsored volunteer events</li><li>
Employee assistance program (EAP)</li></ul><p>
Learn more about our benefits by reviewing the IU Benefit Programs Brochure.</p><p><b>
Job Classification</b></p><p>
Career Level: Career</p><p>
FLSA: Exempt</p><p>
Job Function: Research</p><p>
Job Family: Clinical Research</p><p><b><br>
Posting Disclaimer</b></p><p>
This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.</p><p>
If you wish to include a cover letter, you may include it with your resume when uploading attachments.</p><p><b>
Equal Employment Opportunity</b></p><p>
Indiana University is an equal opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University Notice of Non-Discrimination here which includes contact information.</p><p><b>
Campus Safety and Security</b></p><p>
The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online. You may also request a physical copy by emailing IU Public Safety at iups@iu.edu or by visiting IUPD.</p><p><b>
Contact Us</b></p><p>
Request Support<br>
Telephone: 812-856-1234</p></div>

Clinical Research Coordinator

<div><p><b>Department</b></p><p>
CANCER CENTER (IN-CANC-IUINA)</p><p><b>
Department Information</b></p><p>
The mission of the IU Simon Comprehensive Cancer Center (IUSCCC) Clinical Trials Office (CTO) is to support and facilitate the conduct of quality clinical research by IUSCCC translational clinical investigators. The CTO is a centralized resource available to all clinical investigators of the IUSCCC whose services enable the safe and efficient conduct of adult and pediatric trials. The CTO provides a comprehensive range of services. These services begin in the early stages of protocol development and continue throughout the study implementation, publication and long-term follow-up.</p><p><b>
Job Summary</b></p><ul><li>
Assists with identifying and recruiting potential research study subjects; determines eligibility according to the IRB/protocol approved methodologies, coordinates study procedures, and monitors the progress of research studies or projects.</li><li>
Conducts study visit activities and coordinates screening, consenting, and scheduling of test, exams, and/or non-medical/behavioral interventions and assessments involving study subjects. Coordinates, facilitates, and performs various study activities; manages all follow-up activities with subjects based on protocols.</li><li>
Records study data, samples, and/or results in various databases. Maintains databases for subjects and subject scheduling. Performs data validation checks and pursues resolutions to erroneous data. Produces various reports in response to requests from principal investigator (PI), sub-investigators, and/or other study stakeholders.</li><li>
Monitors study team compliance with protocol and standard operating proceedures (SOPs). Submits all regulatory paperwork required. Communicates with PI and sub-investigators about concerns or recommended changes in study protocols, etc.</li><li>
Assists with developing various communications and strategies for advertising and recruitment, as well as in developing information materials for study participants.</li><li>
Stays up to date on regulatory affairs and/or clinical research best practices by attending continuing education classes, conferences, seminars, and project team meetings.</li><li>
Provides various other clinical research study or project support as needed (such as assisting with budget development, invoicing for adverse events, billing compliance and patient billing resolution).</li><li>
May provide guidance and/or support to less experience clinical research staff.</li></ul><p><b>
Qualifications</b></p><p><i>
Combinations of related education and experience may be considered. Education beyond the minimum required may be substituted for work experience. Work experience beyond the minimum required may be substituted for education.</i></p><p>
</p><p>EDUCATION</p><p><b>
Required</b></p><ul><li>
Bachelor's degree in science or a health-related field plus 1 year of health-related or research experience; <b>OR</b></li><li>
Associate's degree in an allied health profession plus 3 years of health-related or research experience.</li></ul><p>
SKILLS</p><p><b>
Required</b></p><ul><li>
Proficient written and verbal communication skills.</li><li>
Maintains a high degree of professionalism.</li><li>
Demonstrates time management and priority setting skills.</li><li>
Demonstrates a high commitment to quality.</li><li>
Possesses flexibility to work in a fast paced, dynamic environment.</li><li>
Highly thorough and dependable.</li><li>
Possesses a high degree of initiative.</li><li>
Ability to build strong customer relationships.</li></ul><p><b>
Working Conditions / Demands</b></p><p>
The role regularly requires the ability to effectively communicate. The role frequently requires the ability to move about the work environment and to position oneself to operate laboratory equipment effectively. The role requires the ability to move objects weighing up to 25 pounds and will occasionally work near moving mechanical parts. The person in this role must be able to perform the essential functions with or without an accommodation.</p><p><b>
Work Location</b></p><p>
IUSCCC Clinical Trials Office</p><p>
IU Indianapolis Campus</p><p>
Indianapolis, Indiana</p><p><b>
Benefits Overview</b></p><p>
For full-time staff employees, Indiana University offers a wide array of benefits including:</p><ul><li>
Comprehensive medical and dental insurance</li><li>
Health savings account with generous IU contributions</li><li>
Healthcare and dependent care flexible spending accounts</li><li>
Basic group life insurance paid by IU</li><li>
Voluntary supplemental life, long-term disability, critical illness, and supplemental accidental death and dismemberment insurance</li><li>
Base retirement plan with generous IU contributions, subject to vesting</li><li>
Voluntary supplemental retirement plan options</li><li>
Tuition subsidy for employees and family members taking IU courses</li><li>
10 paid holidays plus a paid winter break each year</li><li>
Generous paid time off plans</li><li>
Paid leave for new parents and IU-sponsored volunteer events</li><li>
Employee assistance program (EAP)</li></ul><p>
Learn more about our benefits by reviewing the IU Benefit Programs Brochure.</p><p><b>
Job Classification</b></p><p>
Career Level: Mastery</p><p>
FLSA: Nonexempt</p><p>
Job Function: Research</p><p>
Job Family: Clinical Research</p><p><b><br>
Posting Disclaimer</b></p><p>
This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.</p><p>
If you wish to include a cover letter, you may include it with your resume when uploading attachments.</p><p><b>
Equal Employment Opportunity</b></p><p>
Indiana University is an equal opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University Notice of Non-Discrimination here which includes contact information.</p><p><b>
Campus Safety and Security</b></p><p>
The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online. You may also request a physical copy by emailing IU Public Safety at iups@iu.edu or by visiting IUPD.</p><p><b>
Contact Us</b></p><p>
Request Support<br>
Telephone: 812-856-1234</p></div>

Clinical Research Specialist

<div><p><b>Department</b></p><p>
PHYSICAL MEDICINE and REHAB (IN-PHMR-IUINA)</p><p><b>
Department Information</b></p><p>
The Indiana University (IU) School of Medicine Department of Physical Medicine and Rehabilitation (PMandR) has a strong history of achievement in medical research, education and patient care. PMandR, also known as physiatry, treats conditions involving the body's nervous and musculoskeletal systems that limit a person's ability to function. The teaching faculty in the Department of Physical Medicine and Rehabilitation oversees the only PMandR residency program in the state of Indiana and are eager to uphold the mission of educating the country's next generation of physiatrists.</p><p><b>
Job Summary</b></p><p>
This position will assist in the conduct of clinical research. Current research activities in the center include looking at the effectiveness of walking strategies on short and long-term outcomes during inpatient and outpatient rehabilitation for individuals who have experienced a stroke, brain injury, and/or incomplete spinal cord injury.</p><p>
Department-Specific Responsibilities</p><ul><li>
Assists in recruiting research participants</li><li>
Screens participants to determine eligibility</li><li>
Obtains informed consent from participants and/or legally authorized representative</li><li>
Schedules subjects for appointments</li><li>
Coordinates participant travel arrangements</li><li>
Manages regulatory submissions</li><li>
Assists in conduct of study-related data collection in person and/or over the telephone</li><li>
Extracts data from source documents</li><li>
Participates in exercise therapy interventions as supervised by licensed physical therapists</li><li>
Assists with data collection and analysis</li></ul><p>
General Responsibilities</p><ul><li>
Assists with identifying and recruiting potential research study subjects; determines eligibility according to the Institutional Review Board (IRB)/protocol approved methodologies, coordinates study procedures, and monitors the progress of research studies or projects</li><li>
Conducts study visit activities and coordinates screening, consenting, and scheduling of test, exams, and/or non-medical/behavioral interventions and assessments involving study subjects</li><li>
Coordinates, facilitates, and performs various study activities; manages all follow-up activities with subjects based on protocols</li><li>
Records study data, samples, and/or results in various databases</li><li>
Maintains databases for subjects and subject scheduling</li><li>
Performs data validation checks and pursues resolutions to erroneous data</li><li>
Produces various reports in response to requests from principal investigator (PI), sub-investigators, and/or other study stakeholders</li><li>
Monitors study team compliance with protocol and standard operating procedures (SOPs)</li><li>
Submits all regulatory paperwork required</li><li>
Communicates with PI and sub-investigators about concerns or recommended changes in study protocols, etc.</li><li>
Assists with developing various communications and strategies for advertising and recruitment, as well as in developing information materials for study participants</li><li>
Stays up to date on regulatory affairs and/or clinical research best practices by attending continuing education classes, conferences, seminars, and project team meetings</li><li>
Provides various other clinical research study or project support as needed (such as assisting with budget development, invoicing for adverse events, billing compliance and patient billing resolution)</li><li>
May provide guidance and/or support to less experience clinical research staff</li></ul><p><b>
Qualifications</b></p><p><i>
Combinations of related education and experience may be considered. Education beyond the minimum required may be substituted for work experience. Work experience beyond the minimum required may be substituted for education.
</i></p><p></p><p>EDUCATION / WORK EXPERIENCE</p><p><b>
Required</b></p><ul><li>
Bachelor's degree in science or a health-related field and 1 year of health-related or research experience; <b>OR</b></li><li>
Associate's degree in an allied health profession and 3 years of health-related or research experience</li></ul><p>
SKILLS</p><p><b>
Required</b></p><ul><li>
Proficient written and verbal communication skills</li><li>
Maintains a high degree of professionalism</li><li>
Demonstrates time management and priority setting skills</li><li>
Demonstrates a high commitment to quality</li><li>
Possesses flexibility to work in a fast paced, dynamic environment</li><li>
Highly thorough and dependable</li><li>
Possesses a high degree of initiative</li><li>
Ability to build strong customer relationships</li></ul><p><b>
Preferred</b></p><ul><li>
Demonstrates a current interest or previous history in neurologic rehabilitation of individuals who have experienced a stroke, brain injury, and/or incomplete spinal cord injury is desired</li></ul><p><b>
Working Conditions / Demands</b></p><p>
The role regularly requires the ability to effectively communicate. The role frequently requires the ability to move about the work environment and to position oneself to operate laboratory equipment effectively. The role requires the ability to move objects weighing up to 25 pounds and will occasionally work near moving mechanical parts. The person in this role must be able to perform the essential functions with or without an accommodation.</p><p><b>
Work Location</b></p><p>
IU Locomotor Recovery Center, Rehabilitation Hospital</p><p>
Indianapolis, Indiana</p><p><b>
Benefits Overview</b></p><p>
For full-time staff employees, Indiana University offers a wide array of benefits including:</p><ul><li>
Comprehensive medical and dental insurance</li><li>
Health savings account with generous IU contributions</li><li>
Healthcare and dependent care flexible spending accounts</li><li>
Basic group life insurance paid by IU</li><li>
Voluntary supplemental life, long-term disability, critical illness, and supplemental accidental death and dismemberment insurance</li><li>
Base retirement plan with generous IU contributions, subject to vesting</li><li>
Voluntary supplemental retirement plan options</li><li>
Tuition subsidy for employees and family members taking IU courses</li><li>
10 paid holidays plus a paid winter break each year</li><li>
Generous paid time off plans</li><li>
Paid leave for new parents and IU-sponsored volunteer events</li><li>
Employee assistance program (EAP)</li></ul><p>
Learn more about our benefits by reviewing the IU Benefit Programs Brochure.</p><p><b>
Job Classification</b></p><p>
Career Level: Mastery</p><p>
FLSA: Nonexempt</p><p>
Job Function: Research</p><p>
Job Family: Clinical Research</p><p><b><br>
Posting Disclaimer</b></p><p>
This posting is scheduled to close at 11:59 pm EST on the advertised Close Date. This posting may be closed at any time at the discretion of the University, but will remain open for a minimum of 5 business days. To guarantee full consideration, please submit your application within 5 business days of the Posted Date.</p><p>
If you wish to include a cover letter, you may include it with your resume when uploading attachments.</p><p><b>
Equal Employment Opportunity</b></p><p>
Indiana University is an equal opportunity employer and provider of ADA services and prohibits discrimination in hiring. See Indiana University Notice of Non-Discrimination here which includes contact information.</p><p><b>
Campus Safety and Security</b></p><p>
The Annual Security and Fire Safety Report, containing policy statements, crime and fire statistics for all Indiana University campuses, is available online. You may also request a physical copy by emailing IU Public Safety at iups@iu.edu or by visiting IUPD.</p><p><b>
Contact Us</b></p><p>
Request Support<br>
Telephone: 812-856-1234</p></div>

Clinical Research Specialist, Physical Medicine and Rehabilitation

Eli Lilly

<div><p>At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We&rsquo;re looking for people who are determined to make life better for people around the world.</p><p></p><p>
Purpose:</p><p>
Through the application of scientific training and clinical training and expertise, the Development Clinical Research Scientist (CRS) participates in:</p><ul><li>
the development, conduct and reporting of corporate/global clinical trials in support of registration and commercialization of the product(s);</li><li>
the implementation of global clinical trials; the reporting of adverse events as mandated by corporate patient safety;</li><li>
the review process for protocols, study reports, publications and data dissemination for products, new and updated labels, documents and tools supporting product pricing, reimbursement, and access (PRA), grant submissions and contracts;</li><li>
contacts with regulatory and other governmental agencies;</li><li>
outreach medical activities aimed at the external clinical customer community, including leaders with vision;</li><li>
the development and implementation of the business unit and global strategy for the product; and various medical activities.</li></ul><p></p><p>
The clinical research scientist serves as a scientific resource for study teams, departments, and others as needed. The Clinical Research Scientist must be aware of and ensure that all their activities are in compliance with current local and international regulations, laws, guidance's (for example, FDA, ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly policies and procedures, company integrity agreements as applicable, and the Principles of Medical Research and activities are aligned with the medical vision.</p><p><b>
Primary Responsibilities:</b></p><p>
This job description is intended to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Coordinate with your supervision regarding your actual job responsibilities and any related duties that may be required for the position.</p><p>
The primary responsibilities of the Development CRS are generally related to late-phase and marketed compounds. The core job responsibilities may include those listed below as deemed appropriate by line management, as well as other duties as assigned.</p><p></p><p>
1) Clinical Planning</p><ul><li>
Collaborate with cross-functional partners in clinical design, discovery, medical development, biostats, safety, PRA, clinical pharmacology, etc. in the development and maintenance of a product profile that addresses key customer needs (patient, provider, and payer); the product lifecycle plan, clinical strategies, development plans and study protocol design.</li><li>
Understand and keep updated with the pre-clinical and clinical data relevant to the molecule.</li></ul><p>
2) Clinical Research/Trial/ Execution and Support</p><ul><li>
Plan, collaborate, and review scientific content of clinical documents such as protocols, informed consent documents, final study reports, and submissions (e.g., annual reports) according to the agreed upon project timeline.</li><li>
Provide protocol oversight and input into informed consent documents.</li><li>
Supports the monitoring of patient safety during study and participates in the global product safety reviews including the appropriate tracking and follow-up of adverse events, in alignment with corporate patient safety policies and procedures.</li><li>
Collaborate with clinical research staff in the design, conduct and reporting of local clinical trials (for example, sample size, patient commitment, timelines, grants, and governance review interactions).</li><li>
Participate in investigator identification and selection, in conjunction with clinical teams.</li><li>
Ensure that operational team has documented the completion of administrative requirements for study initiation and conduct (for example, ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and local laws and requirements.</li><li>
Assist in the planning process of study start-up meetings and other activities to provide the appropriate training and information to investigators and site personnel.</li><li>
Serve as resource to clinical operations/CTMs/ clinical research monitors, investigators and ethical review boards to address any questions or clarify issues arising during the conduct of study.</li><li>
Review external proposals and publications, as requested by CRP or Director-Medical</li></ul><p></p><p>
3) Scientific Data Dissemination/Exchange</p><ul><li>
Knowledge of and compliance with local laws and regulations, and global policies and procedures, compliance guidelines with respect to data dissemination and interactions with external health care professionals.</li><li>
Support the planning of symposia, advisory board meetings, and other meetings with health care professionals.</li><li>
Prepare or review scientific information in response to customer questions or media requests</li><li>
Provide telephone follow-up or specific written information requested by health care professionals as per global SOPs.</li><li>
Establish and maintain appropriate collaborations and relationships with external experts, thought leaders, and the general medical community on a local, national, regional and possibly international basis.</li><li>
Develop and maintain appropriate collaborations and relationships with relevant professional societies.</li><li>
Support training of medical personnel, including geographic/affiliate medical personnel as assigned, medical and outcome liaisons and global patient outcomes personnel.</li><li>
Participate in data analysis, development of scientific data dissemination, and preparation of final reports and publications.</li></ul><p></p><p>
4) Regulatory support activities</p><p></p><ul><li>
Support/assist in the preparation of regulatory reports, including NDAs, FDA annual reports and Periodic Adverse Drug Experience Reports (PADERS), preparation for FDA advisory committee hearings and label discussions, local registration efforts, and communication and resolution of regulatory issues, including regulatory response, from a global perspective.</li><li>
Participate in risk management planning along with affiliates and Global Patient Safety (GPS).</li><li>
Participate in development and review of label changes and labeling modifications in collaboration with affiliates, brand teams, regulatory, and legal.</li></ul><p></p><p>
5) Business/customer support (or/and post launch support)</p><ul><li>
Contribute to the development of medical strategies to support brand commercialization activities by working closely with business unit, brand team, clinical plans manager/project management associates and other cross-functional management during the development of the local business plan.</li><li>
Actively address Development customer (payer, patient, and health care providers) questions in a timely fashion by leading data analyses and new clinical or global patient outcomes research efforts.</li><li>
By offering scientific and creative input, contribute to the development, review, and approval of promotional materials and tactics, as needed.</li></ul><p></p><p>
6) Scientific I Technical Expertise and continued development</p><ul><li>
Critically read and evaluate the relevant medical literature; know the status and data from competitive products; and keep updated with medical and other scientific developments relevant to the product or therapeutic area</li><li>
Acts as scientific consultant and protocol expert for clinical study team members and others in medical.</li><li>
Be aware of current trends and projections for clinical practice and access in the therapeutic area(s) relevant to the product</li><li>
Participate in the development and implementation of the business unit and global strategy for the therapeutic area</li></ul><p></p><p>
7) General Responsibilities</p><ul><li>
Actively set and meet individual professional development goals and contribute to the development of others.</li><li>
Support the management team in preparation and administration of the business unit development plans and activities.</li><li>
Collaborate proactively and productively with all alliance, business and vendor partners.</li></ul><p></p><p>
Minimum Qualification Requirements:</p><p>
A:</p><p>
An advanced health/medical/scientific (for example, in Pharmacology, physiology, microbiology) or related graduate degree such as DVM, PharmD, PhD, MSN with advanced clinical specialty (Clinical Nurse Specialist/Nurse Practitioner) and one of following:<br>
1. 3-5 years of clinical experience or<br>
2. 3-5 years of pharmaceutical experience (2 of which is in clinical development)</p><p><br>
OR</p><p>
B:</p><p>
 Have a BS or Masters degree in health/medical/scientific or related field and 7-10 years of pharmaceutical experience that is directly related to at least one of the following:<br>
1. Clinical trial experience<br>
2. Experience in areas relevant to drug discovery<br>
3. Drug/clinical development experience (for example, epidemiology, toxicology, pharmacology, regulatory affairs, medical affairs)</p><p>
If experience is either in 2 and or 3 only (for example, no clinical trial experience), the following must be provided as supporting evidence of candidate&rsquo;s ability/capability to perform in a CRS role:</p><ul><li>
Clear evidence and documentation of candidate's direct role and contribution to medical content. This should include evidence of candidate as medical content owner (oversight of content development-creator/creation, reviewer, and approver. Medical content= medical, scientific or clinical information)</li><li>
Candidate's selection for CRS role must be endorsed by the Med affairs/development VP or equivalent area Senior leadership.</li></ul><p></p><p>
Other minimum requirements:</p><ul><li>
Demonstrated ability to balance scientific priorities with business priorities with examples of successful leadership skills</li><li>
Demonstrated strong communication, interpersonal, teamwork, organizational, and negotiation skills</li><li>
Demonstrated ability to influence others (both cross-functionally and within the function) in order to create a positive working environment.</li><li>
Ability to engage in domestic and international travel to the degree appropriate to support the business of the team.</li><li>
Fluent in English, verbal and written communication</li></ul><p></p><p>
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.</p><p></p><p>
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status.</p><p><br>
Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women&rsquo;s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.</p><p></p><p>
Actual compensation will depend on a candidate&rsquo;s education, experience, skills, and geographic location. The anticipated wage for this position is</p>
$177,000 - $308,000<p></p><p>
Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly&rsquo;s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.</p><p></p><p>
#WeAreLilly</p></div>

Director - Clinical Research Scientist

<p></p><div><div><div><div><div><div><div>The Indiana University (IU) School of Science and the Luddy School of Informatics, Computing, and Engineering at IU Indianapolis invite applications for a tenured Associate or Full Professor position whose research operates at the intersection of biology and biomedical engineering.<br>
</div><div>This position is a strategic joint hire aligned with the Convergent Bioscience and Technology Institute (CBATI) and is intended to strengthen and expand interdisciplinary research capacity across biology, biomedical engineering, and translational biosciences.<br>
</div><div><b>Strategic Research Areas of Interest</b></div><div>
Priority consideration will be given to candidates whose research programs align with one or more of the following areas:<br>
<ul><li>Bacterial pathogenesis and antibiotic resistance, including microbiology, immune engineering, and host&ndash;pathogen interactions</li><li>Biohybrid and bioinspired materials and biological&ndash;synthetic interfaces</li><li>Bio-machining, bio-manufacturing, and biofabrication, including bioprinting and scalable living systems</li><li>Regenerative biology and regenerative medicine with translational relevance</li></ul><br>
</div><div><b>
Role within the Convergent Bioscience and Technology Institute (</b><b>CBATI</b><b>)</b></div><div>
The Convergent Bioscience and Technology Institute (CBATI) drives interdisciplinary bioscience and technology research and collaboration with industry partners in pursuit of discoveries ranging from wearable and implantable medical devices and sensors to the advanced detection of biomarkers and AI-enabled drug discovery and delivery. With a goal of quickly delivering IU health and sciences innovations from the bench to bedside, the institute will aim to stimulate substantial growth in the disclosure and licensing of inventions, discoveries and innovations, as well as industry partnerships and IU-launched startup companies.<br>
</div><div>This position is affiliated with the Convergent Bioscience and Technology Institute (CBATI), IU Indianapolis&rsquo; institute dedicated to advancing convergent bioscience and technology research. Faculty affiliated with CBATI are expected to participate actively in interdisciplinary research efforts and collaborative proposal development.<br>
</div><div>IU has also recently broken ground on the <b>Launch Accelerator for Biosciences (IU </b><b>LAB</b><b>)</b> &ndash; a first-of-its kind academic-industry initiative to harness Indiana&rsquo;s extensive resources in bioscience discovery, leading to significant advancements in human health. Supported by a $138 million Lilly Endowment Inc. grant, IU LAB acts as the hub between industry and academia, positioning Indiana and the greater Indianapolis region as an international leader for biosciences research and innovation. IU LAB is expected to open in the 16 Tech Innovation District in 2027.<br>
</div><div>The successful candidate will have opportunities to contribute to shaping collaborative research themes, support interdisciplinary training and mentoring, and engage with translational and industry-facing initiatives through CBATI and IU LAB, consistent with their interests and experience.<br>
</div><div><b>Application Process</b><br>
<b>Open until filled.</b><br>
</div><div>Application materials include:</div><ul>
<li>Curriculum Vitae</li>
<li>Cover Letter</li>
<li>Statement of Research</li>
<li>Statement of Teaching</li>
<li>List of References</li></ul><p></p><div><br>
</div><div>
<b>About the </b><b>Indiana University Luddy School of Informatics, Computing and Engineering &ndash; Indianapolis</b><br>
The Indiana University Luddy School of Informatics, Computing and Engineering is the first completely new school in the United States devoted exclusively to Informatics and a range of its subdisciplines. With its formative national role in creating the nation&rsquo;s largest Informatics Program on the Bloomington and Indianapolis campuses, the school is the broadest and one of the largest information/computing schools in the U.S. At IU Indianapolis, the school also has strong ties with the health and life sciences in the areas of health data exchange, clinical decision support, consumer health informatics, integrated health information systems, and interactive health information technologies. The school provides state-of-the-art facilities including fully equipped classrooms, media and gaming labs, human&ndash;computer interaction research labs, usability and mobile development labs, ample research facilities, and studios for sound design and interactive media production. Access to advanced, high-resolution wall-sized displays and virtual environments are also available within the Informatics and Communications Technology Complex. The school has formed key research partnerships with the IU School of Medicine and the Regenstrief Institute, an internationally recognized medical informatics research center. The school also enjoys collaborations with the Roudebush VA Medical Center, IU Health (one of the largest health care organizations in the Midwest), the IU Schools of Nursing, Public Health, Health and Human Sciences, and School of Science. Luddy School faculty have access to state-of-the art computing resources. IU&rsquo;s Quartz supercomputer, Big Red 200 is among the world&rsquo;s fastest research supercomputers. Owned and operated solely by IU, these high-performance resources are designed to accelerate discovery in a wide variety of fields, including biomedicine, biotechnology, health care, and enable effective analysis of large, complex biomedical data sets (i.e., big data).<br>
</div><div><b>About the </b><b>Indiana University School of Science</b><br>
The School of Science is home to six departments and two interdisciplinary academic programs that serve over 2000 students. Each of the six departments hosts thriving PhD and research programs. The Department of Biology has 25 full-time faculty members, over 750 undergraduate majors, and approximately 60 graduate students enrolled in Ph.D. and M.S. programs. The Department of Biology has a strong record of externally funded research, well-equipped research laboratories and several core facilities. With an extensive hospital system and the IU School of Medicine, IU Indianapolis is home to a large and vibrant community of researchers and collaborators in all areas of biomedical science. Consistent with our health and life science focus, many faculty in the department have strong connections with the IU School of Medicine (<b>Indiana University School of Medicine (iu.edu)</b>) on the same campus, and pursue strong, externally funded, programmatic research.<br>
</div><div><b>About </b><b>Indiana University Indianapolis</b><br>
The IU Indianapolis campus, with over 21,000 students, is located adjacent to downtown Indianapolis. IU Indianapolis is the health and life science campus of Indiana University, the focal point of health profession education in the State of Indiana. IU Indianapolis offers a full range of academic programs, and is an academic leader in the development and use of information technology. IU Indianapolis shares a campus with the Indiana University School of Medicine, the largest medical school in the US. IU Indianapolis is an eight-time recipient of the Higher Education Excellence in Diversity Award by Insight into Diversity. IU Indianapolis is a campus renowned for service learning, civic engagement, and health sciences research.<br>
</div><div><b>About Indianapolis</b><br>
Indianapolis is the nation&rsquo;s 16th largest city, the capital of Indiana, home to the Indianapolis Motor Speedway, the NCAA, the Indianapolis Colts and Indiana Pacers, Indiana Repertory Theatre, Indianapolis Symphony, Indianapolis Ballet, Indianapolis Museum of Art, Indianapolis Zoo and one of the country&rsquo;s most livable big cities.<br>
</div><div>Indiana is entering a new era of dynamic growth led by the biosciences, manufacturing, artificial intelligence, healthcare and hospitality industries. Just last year, Indiana&rsquo;s biosciences sector generated over $99 billion in economic activity, while its hospitality industry welcomed 30 million visitors who contributed $5.8 billion of economic impact. Indianapolis is a significant biotech hub, anchored by global giants like Eli Lilly and Roche, alongside numerous other major players like Elanco, AstraZeneca, Merck, and Sanofi, plus specialized firms such as Zimmer Biomet, INCOG BioPharma, Genezen Labs, and Beckman Coulter, making it a strong center for pharmaceuticals, diagnostics, and life sciences.<br>
</div><div>To learn more about Indianapolis, see any of the following websites:</div><ul>
<li><b>IndyParks</b>, with over 150 parks in and around the city</li>
<li><b>Local Government &amp; Neighborhoods</b></li>
<li><b>Downtown Indianapolis</b></li>
<li><b>Tourism</b></li>
<li>Indianapolis Monthly&rsquo;s <b>&ldquo;Best of Indy&rdquo;</b>
</li><li><b>Carmel, Indiana</b>, rated the #1 Best Place to Live in the U.S.<br>
</li>
</ul></div></div><br>
<div><div><b>Basic Qualifications</b></div>
<div><div><b>Basic Qualifications</b></div><ul>
<li>Ph.D. or equivalent terminal degree in Biology, Biomedical Engineering, Bioengineering, Biotechnology, or a closely related discipline</li>
<li>Appointment at the tenured Associate or Full Professor level at time of hire</li>
<li>Demonstrated ability to sustain an externally funded research program</li>
<li>Evidence of effective teaching and mentoring.</li>
</ul></div>
</div><br>
<div><div><b>Department Contact for Questions</b></div>
<div>Jeff Hostetler, HR Business Partner, jehostet@iu.edu.</div>
</div><br>
<div><div><b>Additional Qualifications</b></div>
</div><br>
<div></div><div><div><b>Salary and Rank</b></div>
</div><br>
<div></div><div><div><b>Special Instructions</b></div>
</div><br>
<div></div><div><div><b>For Best Consideration Date</b></div>
</div><br>
<div></div><div><div><b>Expected Start Date</b></div> <div>08/01/2026</div>
</div><br>
<div><div><b>Posting Number</b></div> <div>IU-101454-2026</div></div></div></div></div></div>

Associate or Full Professor in Convergent Biology and Biomedical Engineering

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