clinical research project manager

University of Pennsylvania

<div>University Overview
The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News &amp; World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn&rsquo;s distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America&rsquo;s Best Large Employers in 2023.
Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.
The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more.
Posted Job Title
Clinical Research Project Manager C
Job Profile Title
Clinical Research Project Manager C
Job Description Summary
The Palliative and Advanced Illness Research Center is seeking a Senior Project Manager to support the operations of the Center&rsquo;s Data Core and provide direct support to the Associate Director of Clinical Research Data Management to ensure consistent, high-quality delivery of data services. The Project Manager will serve as a key interface between investigators and research staff. They will allocate data-core resources and oversee execution of data work across multiple study portfolios, providing regular updates on progress, workflows, and timelines. They will be responsible for the quality of the Data Core&rsquo;s output by conducting code reviews and developing standards for efficient workflows, version control, and data management best practices.
Job Description
Job Responsibilities
Allocating data management personnel and resources across project tasks
Monitoring progress and serving as an intermediary with investigator-led teams
Providing administrative supervision to data managers, including workload planning, time off coordination and approvals, and performance feedback
Coordinating code reviews and establishing standards for data quality checks
Guiding execution of data use agreements and ensuring compliance with data sharing plans
Reviewing IRB protocols for feasibility and compliance with confidentiality, data security, and HIPAA standards
Developing standard procedures for file transfers and naming conventions
Coordinating access to HIPAA-compliant computing resources
Contributing to data acquisition for projects and tasks as needed based on available Data Core resources
Position Contingent Upon Funding
Qualifications
Bachelor's Degree with 7-10 years of related experience or equivalent combination of education and experience is required. Master's degree and 5-7 years of experience preferred.
Preferred:
The candidate must be highly organized with excellent written and oral communication skills. Experience working with electronic health record data and familiarity with programming in R, Python, or SQL.
Above all, attention to detail and the ability to clearly and concisely convey nuanced technical information to different audiences (project managers, investigators, technical and non-technical external stakeholders, biostatisticians, other data managers) will be essential to this individual&rsquo;s success in the position
Prior experience (or equivalent combination) in healthcare research, or a similar technical field.
5 years of project and/or data management experience
Job Location - City, State
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$89,500.00 - $106,940.00 Annual Rate
Salary offers are made based on the candidate&rsquo;s qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job&rsquo;s level. Internal organization and peer data at Penn are also considered.
Equal Opportunity Statement
The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law.
Special Requirements 
Background checks may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
University Benefits<ul><li>
Health, Life, and Flexible Spending Accounts: Penn offers comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits to protect you and your family&rsquo;s health and welfare. You can also use flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars.</li><li>
Tuition: Take advantage of Penn's exceptional tuition benefits. You, your spouse, and your dependent children can get tuition assistance here at Penn. Your dependent children are also eligible for tuition assistance at other institutions.</li><li>
Retirement: Penn offers generous retirement plans to help you save for your future. Penn&rsquo;s Basic, Matching, and Supplemental retirement plans allow you to save for retirement on a pre-tax or Roth basis. Choose from a wide variety of investment options through TIAA and Vanguard.</li><li>
Time Away from Work: Penn provides you with a substantial amount of time away from work during the course of the year. This allows you to relax, take vacations, attend to personal affairs, recover from illness or injury, spend time with family&mdash;whatever your personal needs may be.</li><li>
Long-Term Care Insurance: In partnership with Genworth Financial, Penn offers faculty and staff (and your eligible family members) long-term care insurance to help you cover some of the costs of long-term care services received at home, in the community or in a nursing facility. If you apply when you&rsquo;re newly hired, you won&rsquo;t have to provide proof of good health or be subject to underwriting requirements. Eligible family members must always provide proof of good health and are subject to underwriting.</li><li>
Wellness and Work-life Resources: Penn is committed to supporting our faculty and staff as they balance the competing demands of work and personal life. That&rsquo;s why we offer a wide variety of programs and resources to help you care for your health, your family, and your work-life balance.</li><li>
Professional and Personal Development: Penn provides an array of resources to help you advance yourself personally and professionally.</li><li>
University Resources: As a member of the Penn community, you have access to a wide range of University resources as well as cultural and recreational activities. Take advantage of the University&rsquo;s libraries and athletic facilities, or visit our arboretum and art galleries. There&rsquo;s always something going on at Penn, whether it&rsquo;s a new exhibit at the Penn Museum, the latest music or theater presentation at the Annenberg Center, or the Penn Relays at Franklin Field to name just a few examples. As a member of the Penn community, you&rsquo;re right in the middle of the excitement&mdash;and you and your family can enjoy many of these activities for free.</li><li>
Discounts and Special Services: From arts and entertainment to transportation and mortgages, you'll find great deals for University faculty and staff. Not only do Penn arts and cultural centers and museums offer free and discounted admission and memberships to faculty and staff. You can also enjoy substantial savings on other goods and services such as new cars from Ford and General Motors, cellular phone service plans, movie tickets, and admission to theme parks.</li><li>
Flexible Work Hours: Flexible work options offer creative approaches for completing work while promoting balance between work and personal commitments. These approaches involve use of non-traditional work hours, locations, and/or job structures.</li><li>
Penn Home Ownership Services: Penn offers a forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, which can be used for closing costs or home improvements.</li><li>
Adoption Assistance: Penn will reimburse eligible employees on qualified expenses in connection with the legal adoption of an eligible child, such as travel or court fees, for up to two adoptions in your household.</li></ul> 
To learn more, please visit: https://www.hr.upenn.edu/PennHR/benefits-pay</div>

Clinical Research Project Manager C

University Of Cincinnati

<div>Current UC employees must apply internally via SuccessFactors<div></div> 
Next Lives at the University of Cincinnati<div> 
Founded in 1819, the University of Cincinnati ranks among the nation&rsquo;s best urban public research universities. Home to more than 53,600 students, 12,000 faculty and staff, and over 360,000 living alumni, UC, a Carnegie 1 institution, combines research prowess with a physical setting The New York Times has called &ldquo;the most ambitious campus design program in the country.&quot; UC's momentum has never been stronger as the anchor of the Cincinnati Innovation District, the oldest cooperative education (co-op) program in the country with students earning $94 million annually through paid experiences, an academic health system, and as a member of the Big 12 Conference. The university contributes $10.6 billion in economic impact to the city and $22.7 billion to the state of Ohio. At UC, next is all of us. Learn more at uc.edu.</div><div></div><div> 
UC is a mission-driven organization where we are committed to student success and positively transforming the community through scholarship and service. We thrive on innovation, making an impact, and fostering an environment where staff and faculty are key contributors to UC&rsquo;s success.</div><div></div><div> 
</div><div><div><div><h2 class="jobSectionHeader">Job Overview</h2></div><div>
As one of the oldest medical schools in the country, the University of Cincinnati College of Medicine (COM) has a reputation for training best-in-class health care professionals and developing cutting-edge procedures and research that improves the health and clinical care of patients. In partnership with the UC Health academic healthcare system and Cincinnati Children&rsquo;s Hospital Medical Center, College of Medicine&rsquo;s doctors and faculty are transforming the world of medicine every day. The Department of Neurology &amp; Rehabilitation Medicine is a top-tier department with world-renowned faculty and staff. With world-class research, teaching and medical practice opportunities, why not choose the University of Cincinnati College of Medicine? 
UC is one of the largest employers in the Cincinnati region, employing over 15,000 full-time and part-time faculty, staff and student workers. 
Founded in 1947, the UC Department of Neurology and Rehabilitation Medicine is revolutionizing medicine by connecting discovery and education to world-class care in neurological diseases. Our vision is to be the model organization that integrates neurologic clinical care, research and education. 
The University of Cincinnati, College of Medicine, Department of Neurology and Rehabilitation Medicine is seeking a full-time Clinical Research Project Manager for the NIH-funded StrokeNet Thrombectomy Endovascular Platform (STEP) clinical trial. STEP is a unique, first-of-its-kind platform trial that is looking at various treatments for patients with an Acute Stroke. As the Prime Project Manager of, the candidate will oversee several aspects of national project management for this unique clinical trial. The project manager will work directly with performance sites in the clinical trial. The appropriate candidate should have a clinical background and extensive clinical research experience.</div></div><div><div><h2 class="jobSectionHeader"> 
Essential Functions</h2></div><div><ul><li>
Monitor and report on the progress of delegated clinical trials, which includes budgets and timelines</li><li>
Prepare, oversee, and review documents that are related to the assigned clinical study</li><li>
Arrange or help in organizing clinical study meetings</li><li>
Ensure the availability of necessary resources for the execution of clinical projects</li><li>
Help develop training materials and train clinical staff at sites</li><li>
Communicate with sites regarding key study updates during study webinars and other avenues</li><li>
Lead the clinical project team and various study team meetings</li><li>
Fully involved in resolving issues; take part in procedure improvement initiatives</li><li>
Attain clinical study goals by working with other members of the study team to outline their priorities, and to also resolve conflicts that may come up in the project process</li><li>
Work hand-in-hand with the study team to manage documents that are related to the clinical study</li><li>
Responsible for maintaining the protocol versions and manual of procedures for the trial</li><li>
Help prepare safety reports in collaboration with clinical leaders of the project and sites</li><li>
Work collaboratively with team members to ensure regulatory compliance</li><li>
Perform related duties based on departmental need. This job description can be changed at any time</li></ul></div></div><div><div><h2 class="jobSectionHeader"> 
Required Education</h2></div><div><ul><li>
Bachelor&rsquo;s Degree</li><li>
Nine (9) years of relevant work experience and/or other specialized training can be used in lieu of education requirement.</li></ul></div></div><div><div><h2 class="jobSectionHeader"> 
Required Experience</h2></div><div>
Five (5) years related experience.</div></div><div><div><h2 class="jobSectionHeader"> 
Additional Qualifications Considered</h2></div><div><ul><li>
Possess excellent communication skills so as to be able to effectively convey messages across to both study team members and other external people like vendors and external consultants</li><li>
Good problem-solving, organizational, and leadership skills are highly required</li><li>
Ability to work with little or no supervision</li><li>
Ability to pay keen attention to detail at all times</li><li>
Must be able to work within stipulated timeframes or deadlines even in the face of multiple responsibilities or projects</li><li>
Must be able to work as part of a team or in most cases lead a team</li><li>
Must have a &lsquo;one of a kind&rsquo; work ethic, and must exhibit a great level of self-discipline</li><li>
Ability to organize and motivate other members of the study team</li><li>
Proficient user of basic computer applications for the execution of daily project operations</li><li>
Experience in writing clinical study procedures and other clinical documents is a plus</li></ul><ul><li>
Experience in an academic or clinical setting in the area of clinical specialization</li><li>
SoCRA and/or ACRP certification</li></ul></div></div><div><div><h2 class="jobSectionHeader"> 
Physical Requirements/Work Environment</h2></div><ul><li>
Sitting - Continuously</li><li>
Repetitive hand motion (such as typing) - Often</li><li>
Talking - Often</li><li>
Hearing, listening - Often</li></ul></div></div> 
Compensation and Benefits 
UC offers an exceptional benefits package designed to support your well-being, financial security, and work-life balance. (UC Benefits) Eligibility may vary by position and FTE status. Highlights include: 
Salary/Hourly Pay Rate Information: 
Comprehensive Tuition Remission
UC provides tuition remission for you and your eligible dependents, covering tuition costs for nearly all undergraduate and graduate programs offered by the university. 
Robust Retirement Plans
As a UC employee, you won&rsquo;t contribute to Social Security (except Medicare). Instead, you&rsquo;ll choose between state pension plans (OPERS, STRS) or an Alternative Retirement Plan (ARP), with UC contributing 14&ndash;18% of your salary based on position. 
Real Work-Life Balance
UC prioritizes work-life balance with a generous time-off policy, including:
Vacation and sick time
11 paid holidays and additional end-of-year paid time off (Winter Season Days)
6 weeks of paid parental leave for new parents 
Additional Benefits Include:<ul><li>
Competitive salary based on experience</li><li>
Comprehensive health coverage (medical, dental, vision, prescription)</li><li>
Flexible spending accounts &amp; wellness programs</li><li>
Professional development &amp; mentorship opportunities</li></ul> 
To learn more about why UC is a great place to work, please visit our Careers Page. 
UC is an E-Verify employer. If hired into this position, you will be required to provide satisfactory proof of employment eligibility by providing acceptable, original forms of identification for employment verification via the Federal I-9 employment verification process. Click here for a list of acceptable documents. 
Important: To apply you must create a profile and submit a complete job application through the UC applicant portal. We are unable to consider &ldquo;easy apply&rdquo; applications submitted via other websites. For questions about the UC recruiting process or to request accommodations with the application, please contact UC HR at jobs@uc.edu. 
Equal Opportunity Employer. Building a workplace where all qualified applicants will receive consideration for employment, including Individuals with Disabilities and Protected Veterans. 
REQ: 101946</div>

Clinical Research Project Manager, Department of Neurology & Rehabilitation, STEP

University of Kansas Medical Center

<div><h2 class="jobSectionHeader">Department:
</h2>SOM KC Cancer Center Clinical Trials
-
Clinical Research
<h2 class="jobSectionHeader">Position Title:
</h2>Senior Clinical Research Coordinator - Cancer Center
<h2 class="jobSectionHeader">Job Family Group:
</h2>Professional Staff
<h2 class="jobSectionHeader">Job Description Summary:
</h2>The Senior Clinical Research Coordinator works collaboratively with multidisciplinary teams, research, and hospital staff to recruit, screen, educate, and assist in the overall clinical study coordination of clinical research. The Senior Clinical Research Coordinator will manage assigned clinical research studies by supervising a variety of complex activities involved in the collection, compilation, documentation, and analysis of clinical research data. Participates in periodic quality assurance audits of protocols. Supports the development of study budgets, contracts, and grant applications. Provides task direction, as needed, for junior level clinical research coordinators.
 
 
The University of Kansas Cancer Center is the only National Cancer Institute designated Comprehensive Cancer Center in the region, 1 of only 57 in the nation to receive this distinction. Patients gain access to the most promising therapies, cutting-edge clinical trials and world class research.
<h2 class="jobSectionHeader">Job Description:
</h2>Job Duties Outlined:
<ul><li>Under the direction of the principal investigator, recruit, educate potential patients for and evaluate potential patient eligibility for clinical trials.
</li><li>Assist clinical staff with maintaining source documents and submit case report forms (CRFs) as required for clinical trials.
</li><li>Responsible for lead worker duties including mentoring, training and assisting junior staff with onboarding and learning the clinical research coordinator position.
</li><li>Recognize and report adverse events/serious adverse events to the Principal Investigator, FDA, and sponsors.
</li><li>Assist clinical staff with study procedures, as outlined in the protocol and within state and KUMC scope of practice.
</li><li>Facilitate monitoring visits, reviews and audits. Provide written and verbal reports to Principal Investigator and Project Manager, as required.
</li><li>Prepare and maintain clinical trial contract documents and study budget reports.
</li><li>Perform study procedures, as outlined in the protocol and within state and institutional scope of practice.
</li><li>Assist clinical staff with sample collection, processing, handling, and shipping as outlined in the protocol and within KUMC policy.
</li><li>Ensure adequate study supplies are being maintained. Track study expenditures and submit reimbursement requests for study equipment, supplies and study participants.
</li><li>Prepare documentation and participate in study monitoring visits, reviews and audits. Provide written and verbal reports to Principal Investigator and Project Manager, as required.
</li><li>Attend continuing education, research and training seminars as requested by manager.
</li><li>Participate in quality assurance activities by reviewing clinical data in medical record charts, assessing pharmacy compliance with protocol criteria and reviewing study documentation to ensure compliance with GCP guidelines and FDA CFR.
</li><li>Coordinate closely with the Research Institute and Human Research Protection Program and have a significant working knowledge of KUMC policies and procedures.
</li><li>Review and assist with editing of new protocols. Assesses feasibility of research protocol including appropriate patient population, budget and specific needs for the study.
</li><li>Assist Principal Investigators with internal and external funding application submissions.
</li></ul>This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. It is only a summary of the typical functions of the job, not an exhaustive list of all possible job responsibilities, tasks, duties, and assignments. Furthermore, job duties, responsibilities and activities may change at any time with or without notice.
Work Environment: This position will be 100% onsite due to the fact this is a patient facing role.
Required Qualifications:
Certification: MUST have Research certification such as Certified Clinical Research Coordinator (CCRC), or Certified Clinical Research Professional (CCRP).
Work Experience:
<ul><li>8 years related work experience. Education may be substituted for education on a year for year basis.
</li><li>Experience with regulations governing clinical research (CFR, GCP, HIPAA).
</li><li>Experience with statutes and guidelines relevant to regulatory affairs in clinical research.
</li></ul>Preferred Qualifications
Education : Master's degree
Skills
<ul><li>Communication.
</li><li>Presentation skills.
</li><li>Organization.
</li><li>Time management skills.
</li><li>Computer skills.
</li></ul>Required Documents
<ul><li>Resume/CV
</li><li>Cover Letter
</li></ul>Comprehensive Benefits Package:
<div><div><div><div>Coverage begins on day one for health, dental, and vision insurance and includes health expense accounts with generous employer contributions if the employee participates in a qualifying health plan. Employer-paid life insurance, long-term disability insurance, and various additional voluntary insurance plans are available. Paid time off, including vacation and sick, begins accruing upon hire, plus ten paid holidays. One paid discretionary day is available after six months of employment, and paid time off for bereavement, jury duty, military service, and parental leave is available after 12 months of employment. A retirement program with a generous employer contribution and additional voluntary retirement programs (457 or 403b) are available. https://www.kumc.edu/human-resources/benefits.html
</div></div></div></div><h2 class="jobSectionHeader">Employee Type:
</h2>Regular
<h2 class="jobSectionHeader">Time Type:
</h2>Full time
<h2 class="jobSectionHeader">Rate Type:
</h2>Salary
Compensation Statement:
The pay range listed for this position is determined by our compensation program using market data and salary benchmarking. A combination of factors is considered in making compensation decisions including, but not limited to, education, experience and training, qualifications relative to the requirements of the position, and funding. At the University of Kansas Medical Center, a reasonable estimate for the starting pay range will be the minimum to midpoint of the posted range, taking into account the combination of factors listed above.
<h2 class="jobSectionHeader">Pay Range:
</h2>$70,200.00 - $105,300.00
Minimum
$70,200.00
Midpoint
$87,700.00
Maximum
$105,300.00</div>

Senior Clinical Research Coordinator - Cancer Center

The Ohio State University Wexner Medical Center

<div>Position Summary
We are seeking a laboratory manager to join an interdisciplinary team led by Dr. Anand Mhatre, Assistant Professor in the School of Health and Rehabilitation Sciences and Director of Rehabilitation Engineering Design Laboratory at The Ohio State University. This position offers a unique opportunity to support cutting-edge research in the areas of assistive technology service provision, outcomes, and implementation.
The Lab Manager will plan, design and manage research projects under the supervision of Dr. Mhatre and be responsible for successful project execution. These projects require interaction with clinicians and patients, lab-based engineering setup, design and fabrication of hardware, digital software development and evaluation, human subject studies, data collection and analyses, and dissemination of research findings through publications and presentations. The lab manager will perform some of these activities while closely working with the researchers, clinicians, staff and students. Additional responsibilities include but are not limited to assistance with clinical coordination, set up agreements, training of undergraduate or graduate students, conduct library research on requested topics, and assist with writing articles or grants, as needed.
This is a great opportunity to build scientific skills and knowledge at the intersection of engineering and health science disciplines, learn new techniques, and position yourself well for your future training and career goals. Although an ideal candidate will have proficiency with some of the basic or advanced research and development work, training will be provided for required skillsets. This is a full-time position based in Columbus, Ohio, with an initial appointment of two years and the possibility of extension based on performance and funding.
Minimum Required Qualifications
Bachelor&rsquo;s Degree in Biological Sciences, Health Sciences, Social Sciences or other medical field, or equivalent combination of education experience required. 1 year of relevant experience required. 2-4 years of relevant experience preferred.
Preferred Qualifications
One year experience in a research capacity collaborating with an interdisciplinary group of practitioners; experience or knowledge in specialty area preferred; knowledge of medical terminology desired; clinical research certification from an accredited certifying agency desired; computer skills required with experience using Microsoft Software applications desired. Clinical or industry experience preferred. Requires excellent organizational, written, and verbal communication skills. Must be able to take direction and appropriate action in a stressful environment. A high degree of dexterity to produce materials on a computer; Requires normal or corrected vision and hearing to normal range; Extensive sitting and frequent walking, occasional lifting or carrying up to 25 pounds.
Function: Research and Scholarship
Sub-Function: Clinical Research
Career Band: Individual Contributor S2
Term (Fixed Term) 40 First Shift</div>

Clinical Research Coordinator - Health and Rehab Sciences

The Geneva Foundation

<div>About the Position
 
 
The Senior Clinical Research Coordinator (CRC) oversees and administers clinical research studies and associated activities. This position will assist with the development and management of study budgets. The Senior CRC will assist with the review of protocol requirements and assist with the collection of impact statements needed to properly assign costs to each assessment/procedure. The Senior CRC will provide feedback on the amount of time necessary for conduct staff to administer assessments and procedures as assigned during the budgeting process. The Senior CRC shall cooperate as necessary with the Geneva Corporate Manager to ensure that studies remain financially healthy, including but not limited to, the review of monthly budget reports as well as budget forecasts. The Senior CRC assists in project planning, and ensures that pre- established work scope, study protocol and regulatory requirements are followed. This position may recruit and coordinate research subjects, as appropriate, and serves as principal administrative liaison for the project. This position oversees and coordinates the provision of administrative and staff services to investigators; develops and maintains record keeping systems and procedures. The Senior CRC may also assist with the preparation of presentations for required review and approval processes, to include public
 
affairs office review as applicable.
 
 
About the Project 
 
This position will support multiple research projects under the MIRROR program. Musculoskeletal Injury Rehabilitation Research for Operational Readiness (MIRROR) delivers high value research, education, training, and infrastructure for over 40 clinically relevant musculoskeletal injury (MSI) studies within the military health system (MHS). MIRROR supports a broad scope of projects, including epidemiological investigation, investigator initiated pilots, and prospective randomized multisite clinical trials. Areas of clinical evaluation comprise general MSI care process models and highly prevalent anatomically-specific (e.g. back, knee, shoulder pain, etc.) targeted interventions with protocols examining effective return-to-duty activities. These studies particularly focus on deployment-limiting MSIs, ensuring that research addresses the challenges faced by service members in maintaining operational readiness. Results of these studies generate evidence-based approaches for future clinical practice guidelines as well as educational opportunities for future military and civilian providers at WRNMMC and USU. 
 
Compensation: $85,000 - $110,000
Qualifications<ul><li>
Bachelors degree or equivalent work experience required; masters degree preferred</li><li>
8 years&rsquo; experience in clinical research preferred</li><li>
5+ years non-profit, research, or healthcare experience desired</li><li>
Certified Clinical Research Coordinator (CCRC) certification preferred</li><li>
US Citizenship required to work at this government site</li><li>
Demonstrated competence in oral and written communication</li><li>
Must be organized, attentive to detail, and possess a positive, friendly and professional demeanor</li><li>
Must be flexible with changing priorities and able to communicate in a diplomatic and professional manner</li><li>
Computer skills including at least intermediate level experience with Excel and other Microsoft Office Software</li><li>
Knowledge of CFR, GCP and ICH guidelines</li></ul>
Management Responsibilities<ul><li>
May manage CRCs in entry-level to mid-level roles, research assistants, and other entry level to mid-level members of the conduct team, as assigned</li><li>
The following management responsibilities are applicable to the Senior CRC in a supervisory role:<ul><li>
Assist with staffing, hiring, salary negotiations and performance review process for conduct staff</li><li>
Conduct counseling, corrective action, up to and including termination, with Human Resources and Director</li><li>
Oversee programmatic/study related conduct ensuring staff perform tasks within scope of project</li><li>
Manage conduct staff to ensure optimal performance on each study</li><li>
Ensure staff demonstrate basic understanding of their job description</li><li>
Plan and facilitate individual and team meetings</li><li>
Assure all staff comply with Foundation and site policies, procedures and SOPs</li><li>
Proactively prepare and conduct site evaluation and study initiation visits</li><li>
Ensure sponsor and Geneva enrollment/milestones, study execution, and monitoring expectations are met on 100% of all studies</li><li>
Cognizant of and promotes networking opportunities with sponsors, subjects, and researchers</li></ul></li></ul>
Responsibilities<ul><li>
Promote safety and confidentiality of research participants at all times</li><li>
Adhere to Occupational Safety and Health Administration (OSHA), Good Clinical Practices (GCP), Good Laboratory Practices (GLP), and infection control procedures</li><li>
Plan and coordinate the initiation of research study protocol, and the implementation of operating policies and procedures</li><li>
Plan, implement and maintain data collection and analysis systems in support of research protocol; may coordinate the collection and analysis of research data</li><li>
Recruit, instruct and coordinate research subjects and/or volunteers, as appropriate to specific study objectives and work scope</li><li>
Coordinate the day-to-day activities of technical support staff specifically engaged in the carrying out of research/clinical protocol, as appropriate to the position; may perform aspects of research protocol, as required, in accordance with specified program objectives</li><li>
Organize and facilitate meetings, conferences, and other events associated with research activities; may perform and/or coordinate outreach activities, as appropriate to research objectives</li><li>
Document all correspondence and communication pertinent to the research</li><li>
Interact and communicate effectively with Principal Investigator, other site personnel, research participants, The Geneva Foundation, and the funding organization</li><li>
Comply with all the rules and regulations as applicable to assigned duty station</li><li>
Create and adhere to a data quality and quality assurance plan</li><li>
Assist with interim and annual reports. S/he will be the primary liaison at the data collection site and will be responsible for explaining the project to military personnel associated with the study</li><li>
Demonstrate proficiency in performing basic study related procedures</li><li>
Complete required and applicable research training needed to complete research</li><li>
Maintain and update files of all applicable regulatory documentation for IACUC or IRB (including protocols, approvals, amendments, modifications, etc.) as well as any communications with the sponsor or any other Federal or regulatory office (including prior approvals, change in scope, etc.</li><li>
Manage study budgets to ensure that projects remain financially healthy and viable</li><li>
Cooperative with institutional compliance and monitoring efforts related to the study(ies) and report instances of noncompliance to the PI and the institutional compliance office as appropriate. Coordinate and facilitate monitoring and auditing visits. Notify PI and appropriate institutional officials of external audits and inspections by FDA and sponsors.</li></ul></div>

Senior Clinical Research Coordinator

Terumo Aortic

<div>
 
 
 JOB TITLE
 
 
 
 Clinical Trials Assistant
 
 
 
 DEPARTMENT
 
 
 
 Clinical Affairs
 
 
 Non-Exempt
 
 
 
 MAIN PURPOSE OF JOB AND OBJECTIVES
 
 
 
 
 
 
 Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
 
 
 
 
 
 Clinical Research Assistant is responsible for providing administrative, organizational, technical, and project management support to Study Manager, for new and ongoing medical device trials.
 
 
 
 
 
 
 POSITION IN ORGANISATION
 
 
 
 
 
 
 Position in organization can be found on the Organizational Chart via the company intranet.
 
 
 
 KEY DUTIES
 
 
 
 
 
 <ul>
 <li>
 Maintain study information on a variety of databases, tracking this information and filing as appropriate.
 </li>
 <li>
 Assist Clinical Operations Manager in creating, processing, distributing, and managing the receipt of study-related documents (Protocol, Patient Binders, Newsletters, Regulatory Binders, and initial and updated study documents, etc.)
 </li>
 <li>
 Coordinating and scheduling team meetings and teleconferences, with internal and external participants, and responsible for generation of meeting minutes
 </li>
 <li>
 Assist Clinical team with managing team calendars, travel arrangements, and expense reports.
 </li>
 <li>
 Assist in setting up and maintaining project files (both computer and hard copies)
 </li>
 <li>
 Serve as a liaison between Clinical Operations Manager, study centers, regional monitors, and Clinical Research Organization
 </li>
 <li>
 Communicate with Clinical Operations Manager as required for study implementation and problem resolution.
 </li>
 <li>
 Assist Clinical Operations Manager in tracking site monitoring frequency and monitoring report submission.
 </li>
 <li>
 Assist in tracking Pre-Study, Initiation, Interim and Close-Out Monitoring Visits
 </li>
 <li>
 Assist in the tracking, communication, and processing of all device orders.
 </li>
 <li>
 Assist in coordination of technical support for implants, and responsible for maintaining calendars and implant schedules.
 </li>
 <li>
 Assist in reviewing data and outstanding/resolved queries to determine site payments and informing accounting when payments are to be issued.
 </li>
 <li>
 Assist in the ongoing review of all Adverse and Serious Adverse Events
 </li>
 <li>
 Assist in the processing and tracking of all Clinical Trial Agreements
 </li>
 <li>
 Assist in site identification and selection.
 </li>
 <li>
 Assist in setting up new study center (sending out study start-up material, providing the site with assistance, coordinating IRB submission, etc.)
 </li>
 <li>
 Preparation of correspondence to the sites (mailings, memos/notes to file, etc.)
 </li>
 <li>
 Assist in the planning, coordination, set-up, and implementation of Investigator Meetings
 </li>
 <li>
 Perform various clerical duties (filing, mailing, faxing, creating site files, etc.)
 </li>
 </ul>
 
 
 
 
 
 COMPANY
 
 
 
 
 REQUIREMENTS
 
 
 
 
 
 <ol>
 <li>
 Must work within requirements of company handbook and policy statements.
 </li>
 </ol>
 
 Note: Company Handbook, Policy Statement and Authorization of Limits do not form part of the quality system
 
 
 
 QUALITY
 
 
 
 
 REQUIREMENTS
 
 
 <ol>
 <li>
 Maintain awareness of the relevance and importance of activities performed and how they contribute to the achievement of quality objectives.
 </li>
 <li>
 Work within the QMS always, ensure accurate completion of records and highlight issues to immediate supervisor any issues affecting quality.
 </li>
 <li>
 Responsible to ensure facility, processes and documentation always remain in a state of audit readiness.
 </li>
 </ol>
 
 
 
 
 
 EH&amp;S REQUIREMENTS
 
 
 
 
 
 <ol>
 <li>
 Take care of your own health and safety and that of others who may
 </li>
 <li>
 be affected by your actions.
 </li>
 <li>
 Work co-operatively to highlight issues affecting Environmental Health and Safety
 </li>
 </ol>
 
 
 
 
 
 QUALIFICATIONS &amp; EXPERIENCE
 
 
 
 
 
 <ul>
 <li>
 Excellent written and verbal communication
 </li>
 <li>
 Ability to interact with all levels within internal and external organizations.
 </li>
 <li>
 B.S. in health care/life sciences (strongly preferred)
 </li>
 <li>
 Two years&rsquo; experience in commercial, scientific, laboratory, or administration environment
 </li>
 <li>
 Extremely detail-oriented and organized, with excellent communication and administrative skills
 </li>
 <li>
 Able to manage multiple tasks simultaneously.
 </li>
 <li>
 Excellent computer skills, including expertise in Microsoft Office Programs; familiarity with IBM / Lotus Notes beneficial.
 </li>
 <li>
 Good understanding of the clinical trial process and regulatory requirements (preferred)
 </li>
 </ul>
 
 
</div>

Clinical Research Assistant

Kaiser Permanente

<div><div>Job Summary:</div>
 
Collects data for clinical trials research, independently. Prepares and/or supports the submission of study documentation to regulatory bodies (e.g., IRB) for pre-implementation review and approval. May support clinical trials activities and research lab operations. Completes timely and accurate documentation of all research activities (e.g., consent forms, reports). Assists with the development and/or implementation of standard and non-standard quality control and/or assurance measures and documents feedback to research staff and management. Supports and develops materials for the education of research staff and/or participants on protocols, documentation procedures, clinical best practices, or timeliness of submissions, with limited guidance. Learns about providing input on implementing budgeting components for internally funded standard and non-standard projects. Drafts and/or prepares and submits clinical trials applications in compliance and consistency with all applicable federal, state, and local regulations and KP policies and procedures.<div> 

Essential Responsibilities:</div> 
 
<ul><li>Pursues effective relationships with others by proactively providing resources, information, advice, and expertise with coworkers and members. Listens to, seeks, and addresses performance feedback; provides mentoring to team members. Pursues self-development; creates plans and takes action to capitalize on strengths and develop weaknesses; influences others through technical explanations and examples. Adapts to and learns from change, challenges, and feedback; demonstrates flexibility in approaches to work; helps others adapt to new tasks and processes. Supports and responds to the needs of others to support a business outcome.</li> 
<li>
Completes work assignments autonomously by applying up-to-date expertise in subject area to generate creative solutions; ensures all procedures and policies are followed; leverages an understanding of data and resources to support projects or initiatives. Collaborates cross-functionally to solve business problems; escalates issues or risks as appropriate; communicates progress and information. Supports, identifies, and monitors priorities, deadlines, and expectations. Identifies, speaks up, and implements ways to address improvement opportunities for team.</li> 
<li>
Works on budgeting and financing by: developing a working understanding of how to provide input on implementing budget components for internally funded standard and nonstandard projects.</li> 
<li>
Conducts clinical research by: independently collecting data in clinical trials (e.g., recruiting human subjects, administering surveys and/experiments); leveraging a comprehensive foundational knowledge of source data and the tools leveraged for analyzing, and interpreting clinical data; leveraging a comprehensive foundational knowledge of clinical trials, studies, and interventions at the site-level; independently contributing to the development of standard and nonstandard clinical research protocols and other processes of clinical trials; preparing and/or supporting the submission of study documentation to regulatory bodies (e.g., IRB) for review and approval prior to implementation; may also be responsible for executing standard and non-standard clinical trial activities (e.g., informed consent process, lab support and processing, pharmaceutical documentation data, sample processing, adverse event assessment process); and may be involved in supporting standard and non-standard research lab operations(e.g., biological specimen collection, including patient preparation, labeling, handling, preservation or fixation, processing or preparation, and transportation and storage of specimens).</li> 
<li>
Ensures research compliance by: independently drafting and/or preparing and submitting clinical trial applications in compliance and consistency with all applicable federal, state, and local regulations, and reviewing and providing input on KP compliance policies and procedures; identifying compliance and/or quality issues and assisting in the development of corrective action plans, escalating as necessary; identifying opportunities to update compliance-monitoring/audit systems and documentation; utilizing standard approaches to analyze risk-management data and making recommendations to mitigate potential risk; independently implementing research protocols, procedures, and guidance to ensure confidentiality, privacy, and security of clinical research data; and leveraging comprehensive research expertise to provide guidance to investigators and other key stakeholders to ensure compliance with IRB approved protocols and local and federal guidelines.</li> 
<li>
Maintains internal and external effective working relationships by: leveraging a comprehensive foundational knowledge of how to partner with research stakeholders and investigators within and across units to contribute to research projects; independently communicating with key contractors and subcontractors, study sponsors, collaborating internal and/or external clinical sites, and data coordinating centers as applicable; and developing materials for supporting the education of staff and/or participants on protocols, documentation procedures, clinical best practices, or timeliness of submissions with limited guidance.</li> 
<li>
Ensures documentation of clinical research files by: completing documentation of all research activities (e.g., consent forms, reports, tracking forms) in a timely and accurate manner; assisting with the development and/or implementation of standard and nonstandard quality control and/or assurance measures and documenting feedback for the research staff and management; assessing volunteers and/or patients for eligibility to participate in Clinical Trials using standard procedures and criteria; and leveraging a comprehensive foundational knowledge of how to monitor and audit Clinical Trials as well as documenting findings.</li></ul><div> 
Knowledge, Skills and Abilities: (Core)</div><ul><li>
Ambiguity/Uncertainty Management</li><li>
Attention to Detail</li><li>
Business Knowledge</li><li>
Communication</li><li>
Critical Thinking</li><li>
Cross-Group Collaboration</li><li>
Decision Making</li><li>
Dependability</li><li>
Diversity, Equity, and Inclusion Support</li><li>
Drives Results</li><li>
Facilitation Skills</li><li>
Health Care Industry</li><li>
Influencing Others</li><li>
Integrity</li><li>
Learning Agility</li><li>
Organizational Savvy</li><li>
Problem Solving</li><li>
Short- and Long-term Learning &amp; Recall</li><li>
Teamwork</li><li>
Topic-Specific Communication</li></ul><div> 
Knowledge, Skills and Abilities: (Functional)</div><ul><li>
Accountability</li><li>
Adaptability</li><li>
Autonomy</li><li>
Business Relationship Management</li><li>
Clinical Research</li><li>
Clinical Research Quality</li><li>
Compliance</li><li>
Computer Literacy</li><li>
Data Quality</li><li>
Experimental Design</li><li>
Innovative Mindset</li><li>
Laboratory Equipment</li><li>
Laboratory Procedures</li><li>
Managing Diverse Relationships</li><li>
Organizational Skills</li><li>
Project Management</li><li>
Project Management Tools</li><li>
Quality Assurance Process</li><li>
Quantitative Research Methods</li><li>
Research Ethics</li><li>
Stakeholder Management</li><li>
Survey Methodology</li><li>
The Scientific Method</li></ul><div> 
Minimum Qualifications:</div> 
 
<ul><li>Bachelors degree in Science, Public Health, Health Care Administration, or related field AND minimum two (2) years of experience in clinical research or a directly related field OR Minimum five (5) years of experience in clinical research or a directly related field.</li></ul><div> 
Preferred Qualifications:</div><ul><li>
Certified Clinical Research Professional (CCRP) from Society of Clinical Research Associates (SoCRA); OR ACRP Certified Professional, Certified Clinical Research Associate, Certified Clinical Research Coordinator, Certified Principal Investigator, ACRP Medical Device Professional, or ACRP Project Manager from Association of Clinical Research Professionals (ACRP); OR Certified in Healthcare Compliance (CHC) from Healthcare Compliance Association (HCCA).</li><li>
Basic Life Support (BLS) Certification.</li></ul> 
PrimaryLocation : Oregon,Portland,Center for Health Research 
HoursPerWeek : 40 
Shift : Day 
Workdays : Mon, Tue, Wed, Thu 
WorkingHoursStart : 07:00 AM 
WorkingHoursEnd : 05:30 PM 
Job Schedule : Full-time 
Job Type : Standard 
Employee Status : Regular 
Employee Group/Union Affiliation : NUE-NW-01|NUE|Non Union Employee 
Job Level : Individual Contributor 
Job Category : Research 
Department : Center for Health Research - RI Leadership - 1001 
Travel : No 
Kaiser Permanente is an equal opportunity employer committed to fair, respectful, and inclusive workplaces. Applicants will be considered for employment without regard to race, religion, sex, age, national origin, disability, veteran status, or any other protected characteristic or status.</div>

Clinical Research Coordinator III, Clinical Trials

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