study design lead – clinical research , central labs services

associate director / director - global medicines quality organization

associate director, ts/ms manufacturing cmc project management

clinical research specialist Jobs in Indianapolis

clinical research specialist

research technician

study design lead – clinical research , central labs services Jobs in Indianapolis

associate director / director - global medicines quality organization Jobs in Indianapolis

associate director, ts/ms manufacturing cmc project management Jobs in Indianapolis

study design lead clinical research central labs services

Labcorp

<div>Labcorp is a global leader in laboratory services, providing the insights and answers that help healthcare providers, patients, researchers, pharmaceutical companies and health systems make confident decisions and improve outcomes. Through our unparalleled science, data, technology and laboratory network, we advance diagnostics, accelerate innovation and help address some of the world&rsquo;s most important health challenges. As we shape the future of healthcare, we are leveraging advanced technologies, intelligent digital solutions and data-driven innovation across our operations to enhance how work gets done and deliver greater value to customers and patients. With our global scale and deep expertise, you&rsquo;ll have the opportunity to do meaningful work, grow your career and make a real impact on people&rsquo;s health around the world. Together, we&rsquo;re improving health and improving lives. 
Labcorp is seeking a remote Study Design Lead to join our Central Labs Services (CLS) team.
Job Responsibilities<ul><li>Interpret sponsor protocol requirements and translate them into a precise, study‑specific database design that drives the creation of the Statement of Work for each CLS project.</li><li>Apply deep technical, therapeutic area, client, and CLS process knowledge to deliver a complete and accurate database design for the CLS project.</li><li>Engage regularly with external clients throughout all phases of study design and development.</li><li>Partner with internal departments to understand full organizational capabilities and evaluate feasibility of client requests related to study design.</li><li>Serve as a consultant on study design decisions, collaborating with the Global Study Manager (GSM) to identify risks and budget implications, and expanding advisory support at the program level.</li><li>Coordinate internal processes and communications&mdash;including feasibility assessments, material transfer agreements, and supply forecasting&mdash;and ensure all follow‑up actions are incorporated into the database and global monitoring plan. Conduct thorough quality self‑review.</li><li>Document all client requirements related to study design and ensure they are fully addressed.</li><li>Manage a diverse portfolio of global and local studies with varying levels of complexity.</li></ul>
Minimum Qualifications
High School Diploma
7 or more years of professional experience working in clinical or preclinical research
1 or more years of experience working directly with clients and stakeholders
Preferred Qualifications
Bachelor&rsquo;s degree in life sciences
2 or more years of experience working directly with clients and stakeholders
Additional Job Standards<ul><li>Strong scientific acumen with an investigative, analytical mindset.</li><li>Self‑starter with the ability to independently identify and obtain needed information.</li><li>Familiarity with clinical or preclinical research protocols.</li><li>Strong planning, organizational, and problem‑solving capabilities.</li><li>Excellent verbal and written communication skills.</li><li>Proven relationship‑building and relationship‑management skills.</li><li>Effective at managing shifting timelines, evolving priorities, and competing demands with clarity and discipline.</li></ul>
At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations.
Central Laboratory Services is part of a global contract research organization within Labcorp. We offer the world&rsquo;s largest network of central laboratories and support global clinical trials testing. A common set of processes, procedures, and instrumentation is offered throughout our sites in Europe, Asia/Pacific, and the United States, allowing us to receive samples globally and provide more than 700 assays across all laboratory science disciplines.
Application Window: Closes at the end of the day August 4, 2026.
Pay Range: 70-90K
All job offers will be based on a candidate&rsquo;s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data.
Benefits: Employees regularly scheduled to work 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(k), Paid Time Off (PTO) or Flexible Time Off (FTO), Tuition Reimbursement and Employee Stock Purchase Plan. Employees regularly scheduled to work less than 20 hours, Casual, Intern, and Temporary employees are only eligible to participate in the 401(k) Plan. For more detailed information, please click here. 
Labcorp is proud to be an Equal Opportunity Employer:
Labcorp strives for inclusion and belonging in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications and merit of the individual. Qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex (including pregnancy, childbirth, or related medical conditions), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. Additionally, all qualified applicants with arrest or conviction records will be considered for employment in accordance with applicable law. 
We encourage all to apply
If you are an individual with a disability who needs assistance using our online tools to search and apply for jobs, or needs an accommodation, please visit our accessibility site or contact us at Labcorp Accessibility. For more information about how we collect and store your personal data, please see our Privacy Statement.</div>

Study Design Lead – Clinical Research , Central Labs Services

American Oncology Network

<div>Location:
Hematology Oncology of Indiana
Pay Range:
$24.83 - $46.12<h1 class="jobSectionHeader">
Job Description Summary</h1>
Responsible for the performance of the research study under the medical supervision of the Principal Investigator. Clinical Research Coordinator III (RN) performs tasks independently, consistently and accurately, and demonstrate that they have achieved a moderate level of expertise in all of their skills and abilities resulting in high quality work. Responsibility includes complex types of study designs (phase 1-3 interventional trial design) and associated study procedures. Demonstrates working knowledge of all facets of role, relevant regulations, and organizational and departmental policies and procedures. Performs other duties and projects as assigned. Performs all duties in accordance with regulatory requirements and organizational policies and procedures.<h1 class="jobSectionHeader">
Primary Key Performance Areas</h1>
KPA 1 &ndash; Protocol Comprehension and Implementation: Coordination of care for patients on clinical research protocols in accordance with GCP, ICH/FDA guidelines and requirements.<ul><li>
Demonstrate an understanding of protocol elements / requirements and demonstrate the ability to execute study procedures. Demonstrate the ability to anticipate and mitigate the potential for protocol non-compliance.</li><li>
Conduct protocol feasibility assessments and complete feasibility/site assessment questionnaires.</li><li>
Assess subjects on the basis of inclusion/exclusion criteria and demonstrate the ability to evaluate and document subject eligibility independently.</li><li>
Reviews draft informed consent documents in compliance with regulatory requirements and GCPs. Conduct an informed consent discussion in compliance with SOPs.</li><li>
Review and interpret diagnostic test results and related documentation required per protocol.</li><li>
Follows process for capturing, assessing, determining causal relationship of adverse events to the investigational product, investigator oversight, reporting and following up on adverse events. Recognize, report and follow up on all types of adverse events.</li><li>
Dispense study medication in a professional and accountable manner following protocol requirements.</li><li>
Maintain accurate records of the receipt, inventory, distribution and destruction of study-related materials / investigational products and research specimens.</li><li>
Ensure that the investigational drug is received, stored, and documented, and that excess materials are returned to the sponsor according to sponsor guidelines and in accordance with Code of Federal Regulations. Assesses and manages investigational products that have been compromised.</li></ul>
KPA 2 &ndash; Regulatory and Data Integrity<ul><li>
Understanding of the IRB/IEC review, key elements of review considerations, approval and reporting requirements for the site. Complete all IRB/IEC-related documents over the course of a clinical study. Maintains site credentials and ensures updated GCP, licenses remain on file.</li><li>
Comply with reporting of safety related subject discontinuation and safety concerns (AE, SAE or AE of Interest) to the sponsor and IRB/IEC.</li><li>
Autonomously collect, record and report accurate data and demonstrate per FDA guidelines, and review them against the patient&rsquo;s medical record for completeness and accuracy.</li><li>
Ensure scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials.</li><li>
Manage a monitoring visit including appropriate preparations, support, documentation and follow up. Maintain proper (accurate and timely) communication with the monitor and follow up on all monitor requests.</li><li>
Implement a CAPA assessment and follow CAPA related issues through to resolution.</li><li>
Escalates issues of protocol non-compliance to study PI and research department leadership.</li></ul>
KPA 3 &ndash; Research Financial Practices: Budget/Contract execution and practices research billing compliance
<ul><li>Assess a protocol and study plan to develop a study budget.</li><li>
Understanding of the payment terms of the study budget and the and tract items that need to be invoiced for a clinical study.</li></ul><h1 class="jobSectionHeader">
Position Qualifications/Requirements</h1>
Education<ul><li>
Bachelors or Associates degree in Nursing is required.</li></ul>
Certifications/Licenses<ul><li>
Unencumbered RN License in state of employment or multi-state license.</li><li>
Valid state Driver&rsquo;s License for travel to satellite offices and offsite meetings. Compliance with the company Driver Safety Operations and Motor Vehicle Records Check Policy is required.</li></ul>
Previous Experience<ul><li>
2-5 years nursing experience required, oncology preferred.</li></ul>
Core Capabilities<ul><li>
Analysis &amp; Critical Thinking: Critical thinking skills including solid problem solving, analysis, decision-making, planning, time management and organizational skills. Must be detailed oriented with the ability to exercise independent judgment.</li><li>
Interpersonal Effectiveness: Developed interpersonal skills, emotional intelligence, diplomacy, tact, conflict management, delegation skills, and diversity awareness. Ability to work effectively with sensitive and confidential material and sometimes emotionally charged matters.</li><li>
Communication Skills: Good command of the English language. Second language is an asset but not required. Effective communication skills (oral, written, presentation), is an active listener, and effectively provides balanced feedback.</li><li>
Customer Service &amp; Organizational Awareness: Strong customer focus. Ability to build an engaging culture of quality, performance effectiveness and operational excellence through best practices, strong business and political acumen, collaboration and partnerships, as well as a positive employee, physician and community relations.</li><li>
Self-Management: Effectively manages own time, conflicting priorities, self, stress, and professional development. Self-motivated and self-starter with ability work independently with limited supervision. Ability to work remotely effectively as required.</li><li>
Must be able to work effectively in a fast-paced, multi-site environment with demonstrated ability to juggle competing priorities and demands from a variety of stakeholders and sites.</li></ul>
Computer Skills:
<ul><li>Proficiency in MS Office Word, Excel, Power Point, and Outlook required.</li><li>
Prior experience with electronic medical records (EMR) is preferred.</li><li>
Prior experience with clinical trial data entry systems (EDC) preferred.</li><li>
Prior Clinical Trial Management Systems (CTMS) preferred.</li></ul>
Travel: 0%
Standard Core Workdays/Hours: Monday to Friday 8:00 AM &ndash; 5:00 PM
#AONN
#LI-ONSITE</div>

RN - Clinical Research Coordinator

Indiana University

<div>Department
MMGE - HEREDITARY GENOMICS DIV (IN-HGN-IUINA)
Department Information
One of the first human genetics departments in the country, the Department of Medical and Molecular Genetics at IU School of Medicine has a rich history of training geneticists and genetic counselors and providing genetic consultation and counseling services. Currently ranked 5th in the nation among Genetics Departments for NIH Funding, received in 2023, the department contributes to the understanding of numerous genetic conditions through the integration of basic research in genetic and genomic mechanisms, translational research in disease models, and clinical trials in rare and common genetic diseases.
Job Summary
Department Specific Responsibilities<ul><li>
Assists study team in managing travel arrangements for participants with Parkinson's disease, or with an increased risk for developing Parkinson's disease.</li><li>
Processes reimbursements and coordinate with clinical research teams across the US and Canada to aid in study retention.</li></ul>
General Responsiblities<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 procedures (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>
Qualifications
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
EDUCATION/ WORK EXPERIENCE
Required<ul><li>
Bachelor's degree in science or a health-related field and 1 year of health-related or research experience. OR</li><li>
Associate's degree in an allied health profession and 3 years of health-related or research experience.</li></ul>
SKILLS
Required<ul><li>
Proficient 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>
Working Conditions / Demands
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.
Additional Information
This position is grant funded with expected annual renewals. Renewals are contingent on the availability of grant funds.
This position is not eligible for visa sponsorship.
Work Location
IU Indianapolis
This position is eligible for remote work or in-person work. However, this is subject to change in the future based on university policy and business needs.
Advertised Salary
$47,589.00 per year to $52,589.00 per year based upon experience and internal equity within the department.
Benefits Overview
For full-time staff employees, Indiana University offers a wide array of benefits including:<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>
Learn more about our benefits by reviewing the IU Benefit Programs Brochure.
Job Classification
Career Level: Mastery
FLSA: Nonexempt
Job Function: Research
Job Family: Clinical Research
Click here to learn more about Indiana University's Job Framework.
Posting Disclaimer
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.
If you wish to include a cover letter, you may include it with your resume when uploading attachments.
Equal Employment Opportunity
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.
Campus Safety and Security
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.
Contact Us
Request Support 
Telephone: 812-856-1234</div>

Clinical Research Specialist

<div>Department
MMGE - HEREDITARY GENOMICS DIV (IN-HGN-IUINA)
Department Information
One of the first human genetics departments in the country, the Department of Medical and Molecular Genetics at Indiana University (IU) School of Medicine has a rich history of training geneticists and genetic counselors and providing genetic consultation and counseling services. Currently ranked 5th in the nation among Genetics Departments for National Institutes of Health (NIH) Funding, received in 2023, the department contributes to the understanding of numerous genetic conditions through the integration of basic research in genetic and genomic mechanisms, translational research in disease models, and clinical trials in rare and common genetic diseases.
Job Summary<ul><li>
Assists in the conduct of clinical research studies or trials following established protocols and standard operating procedures.</li><li>
Assists with identifying and recruiting subjects for clinical research studies or trials; calls/schedules subjects for appointments per protocol; performs screening, consenting and interviewing/data collection in adherence with the assigned study protocol and in accordance with good clinical principals; collects patient consent and authorization for treatment intervention documents and performs those interventions as needed.</li><li>
Conducts routine experiments and/or coordinates research study procedures in accordance with standard operating procedures (SOPs); receives, collects, and records study data in database; communicates and keeps researchers and/or principal investigator (PI) up-to-date on any problems or concerns related to the research study or trial; may be responsible for collecting clinical samples (such as blood, sample tissue, etc.) for research including any storage measures.</li><li>
Assists with advertising and other information for participant recruitment; assists in developing and sharing educational and informational resources with subjects and families.</li><li>
Ensures proper documentation of Case Report Forms, regulatory documents, PI notes, and any other mandatory study-related documents and ensures quality and accuracy; archives documents for study per sponsor, government and institutional requirements; keeps accurate records and provides necessary documents for regulatory audits.</li><li>
Maintains and manages inventory and research study supplies; may be responsible for facilitating disbursement of study participant payments.</li><li>
Provides various additional research study support (such as protocol research in medical library/online databases, summarizing literature reviews for study hypothesis, grant preparation, manuscript review/editing, literature searches, and/or transcription).</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></ul>
Qualifications
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.
EDUCATION / WORK EXPERIENCE
Required<ul><li>
High school diploma or equivalent (such as HSED or GED) plus 5 years patient-related or research experience that includes 2 years of experience with clinical studies; OR</li><li>
Associate's degree in an allied health profession plus 1 year of patient-related or research experience; OR</li><li>
Bachelor's degree in any field or 3 years of college-level science plus 2 years of patient-related or research experience; OR</li><li>
Bachelor's degree in science or a health-related field.</li></ul>
SKILLS
Required<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></ul>
Working Conditions / Demands
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.
Additional Information
This position is grant funded with expected annual renewals. Renewals are contingent on the availability of grant funds.
This position is not eligible for visa sponsorship.
Work Location
IU Indianapolis
This position is eligible for a hybrid schedule (mix between remote and in-person work), subject to change in the future based on university policy and business needs.
Advertised Salary
$37,598.40 - 42,598.40 per year based on experience and internal equity within the department.
Benefits Overview
For full-time staff employees, Indiana University offers a wide array of benefits including:<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>
Learn more about our benefits by reviewing the IU Benefit Programs Brochure.
Job Classification
Career Level: Intermediate
FLSA: Nonexempt
Job Function: Research
Job Family: Clinical Research
Click here to learn more about Indiana University's Job Framework.
Posting Disclaimer
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.
If you wish to include a cover letter, you may include it with your resume when uploading attachments.
Equal Employment Opportunity
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.
Campus Safety and Security
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.
Contact Us
Request Support 
Telephone: 812-856-1234</div>

Clinical Research Technician

Community Health Network

<div><div><div><div>Category</div>
<div>Administrative &amp; General Support</div>
</div><div><div>Department</div>
<div>Clinical Research Oncology</div>
</div><div><div>Schedule</div>
<div>Full-time</div>
</div><div><div>Facility</div>
<div>Cancer Center South</div>
<div>1440 E County Line Rd 
Indianapolis, IN 46227 
United States</div>
</div><div><div>Shift</div>
<div>Day Job</div>
</div><div><div>Hours</div>
<div>80 hours per pay period</div> 
</div></div><div><div>Join our community 
Community Health Network has an excellent opportunity available within our Clinical Research Oncology Team. If you are looking for challenging work and meaningful advancement, then you should consider a career with Community. 
Where you fit in 
The Clinical Research Assistant will be responsible for recruiting, screening interviewing and consenting study patients to the study protocol; completes study-related documentation and data entry; and assists with administrative activities generally associated with the conduct of clinical trials and support of the department. Supports the coordinators and investigators in identifying, screening, interviewing, and consenting eligible patients for the clinical trial and completing the associated data entry and source documentation in accordance with protocol guidelines, GCP, ICH, local, state and federal standards. Maintains effective data management system to track and report patient recruitment for the clinical trials. Assists with administrative activities generally associated with the conduct of the clinical trials and support of the department as needed and as trained. Collects, processes and ships specimens per protocol and regulations as needed and as trained 
Your exceptional skills<ul><li>
Demonstrates knowledge and understanding of the patient care process</li><li>
Demonstrates compliance with hospital standards, policies and procedures</li><li>
Demonstrates effective written and oral communication skills to a varied audience</li><li>
Demonstrates ability to interact with people from diverse socioeconomic, cultural and ethnic backgrounds</li><li>
Demonstrates organizational and time management skills and must be detail oriented</li><li>
Demonstrates computer competencies in MS Word, Excel, Outlook, and EMR</li></ul> 
Your exceptional qualifications<ul><li>
Minimum of 1-2 years of healthcare experience.</li><li>
High school diploma or equivalent required.</li><li>
Medical Assistant or Medical Office Assistant or combined equivalent experience preferred.</li></ul> 
Your life with Community 
You work hard to provide our patients with the exceptional care, and you deserve benefits to match. Community offers a unique employment package that encompasses not only your day-to-day job, but also your career. 
 
You will have the opportunity to grow your career thanks to scholarships and tuition reimbursement from the Community Health Network Foundation and receive recognition for your achievements. 
 
Apply today for immediate consideration.</div>
Why Community?
At Community Health Network, we build teams that deliver exceptional care through empathy, communication and collaboration. We consider ALL an integral part of the exceptional patient experience. We PRIIDE ourselves on not having employees but Caregivers. Join our Community as we make a difference in your community.</div></div>

Clinical Research Assistant

Eli Lilly

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.
 
Lilly recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development in Lebanon, IN. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact.
 
What You’ll Be Doing: 
As an Informatics Engineer, you will partner with the Process Translation and Analytical Laboratories functional areas and site, group, and global IT teams to implement and support digital laboratory solutions that enable the Foundry’s operational objectives. Your scope includes key lab systems such as Laboratory Information Management Systems (LIMS), Laboratory Execution Systems (LES), Electronic Lab Notebooks (ELN), Chromatography Data Systems (CDS), and Environmental Monitoring (EM) platforms.
 You will be driving and supporting system design, configuration, validation, and release - serving as an IT domain expert (SME) for analytical laboratory IT systems at the Foundry.
 
How You’ll Succeed: 
System Implementation & Configuration
 
<ul>
<li>Lead system design and configuration sessions with analytical lab SMEs for LIMS, LES, ELN, and CDS platforms, translating business and scientific processes into validated technical solutions.</li>
<li>Develop and implement Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols in compliance with 21 CFR Part 11 and EU Annex 11.</li>
<li>Lead data integrity requirements across lab systems and ensure audit readiness for regulatory inspections.</li>
<li>Coordinate instrument integration and data flows between lab equipment and LIMS/LES platforms.</li>
<li>Support site deployment and upgrade of analytical laboratory IT systems throughout the facility’s startup and operational phases.</li>
</ul>
Validation & Compliance
 
<ul>
<li>Produce and maintain Computer System Validation (CSV) documentation, standard operating procedures (SOPs), and validation plans in alignment with applicable regulatory frameworks.</li>
<li>Ensure systems remain in a validated state and lead their lifecycle through releases, recapitalization, and retirement.</li>
<li>Build and maintain awareness of regulatory, legal, and quality requirements impacting the quality control laboratory, ensuring solution requirements comply.</li>
</ul>
Collaboration & Readiness
 
<ul>
<li>Collaborate with site and global IT system teams to ensure operational readiness of laboratory systems supporting the Foundry’s release objectives.</li>
<li>Act as a key IT SME for analytical laboratory IT systems, organizing and educating peers on system use and best practices.</li>
<li>Support audits and provide oversight for management reviews, laboratory metrics, equipment records, and laboratory documentation.</li>
</ul>
Your Basic Qualifications: 
<ul>
<li>Bachelor of Science degree in IT, Chemistry, Pharmacy, Science, Engineering, or related field.</li>
<li>1+ year of relevant experience in information technology, engineering, computer system validation, quality control support, or a related area.</li>
<li>Experience with Computer System Validation (CSV) methodology.</li>
<li>Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.</li>
</ul>
Additional Skills / Preferences: 
<ul>
<li>Strong working knowledge of analytical laboratory IT systems including:</li>
<li>LIMS: LabVantage, LabWare</li>
<li>ELN: Benchling, Signals Notebook, or equivalent</li>
<li>CDS: Empower, or equivalent</li>
<li>LES/MES: L7, MODA, or equivalent</li>
<li>Solid knowledge of CSV process and electronic records/electronic signatures (ERES) requirements.</li>
<li>Experience working in a GMP-regulated environment (pharmaceutical, biotech, or equivalent).</li>
<li>Demonstrated ability to prepare and implement IQ/OQ/PQ protocols and associated documentation.</li>
<li>Experience with API/middleware integration and instrument connectivity between lab equipment and informatics platforms.</li>
<li>Understanding of data integrity frameworks applicable to GMP lab environments.</li>
<li>Familiarity with Agile or iterative delivery methodologies in a regulated setting.</li>
<li>Demonstrated learning agility and curiosity; ability to analyze, anticipate, and resolve complex issues through sound problem-solving.</li>
<li>Ability to accurately translate business and scientific processes into IT requirements and solutions.</li>
<li>Effective communicator across diverse forums and audiences, including technical peers, QA, and business customers.</li>
<li>Certification in relevant IT areas (e.g., ITIL, cloud, AI) is a plus.</li>
</ul>
Location & Work Flexibility
 This role will initially be located out of Indianapolis, IN. Once constructed the permanent location will be based at our new Lilly Medicine Foundry in nearby Lebanon, IN.
 #WeAreLilly
 
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.
 
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.
 
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 (AMECA), Black Employees at Lilly (BE@Lilly), Chinese Culture Network (CCN), EnAble, Evolve, Lilly Indian Network (LIN), Organization of Latinx at Lilly (OLA), Pride (LGBTQ+ Allies), Veterans Leadership Network (VLN) and Women’s Initiative for Leading at Lilly (WILL).
 
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
 $64,500 - $158,400
 
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’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
 
#WeAreLilly

Informatics Engineer - Lilly Medicine Foundry

TRIMEDX

<div>If you are wondering what makes TRIMEDX different, it's that all of our associates share in a common purpose of serving clients, patients, communities, and each other with equal measures of care and performance.<ul><li>
Everyone is focused on serving the customer and we do that by collaborating and supporting each other</li><li>
Associates look forward to coming to work each day</li><li>
Every associate matters and makes a difference</li></ul>
It is truly a culture like no other &mdash; We hope you will join our team! Find out more about our company and culture here.
Ready to lead the way in systems training? Apply today &amp; help us transform healthcare through technology and education.
The Systems Training Specialist II provides TRIMEDX business systems and processes training to associates at the corporate office and onsite in the field. Training is delivered through webinars and in field-based medical environments. Responsibilities include delivering training on TRIMEDX proprietary software and data, developing curriculum, maintaining training materials, and establishing relationships with internal stakeholders and departments. Additionally, this position will assist in developing training measurement processes and test writing. There is frequent interaction with field operations technicians and compliance teams and could require up to 60% travel to support new customer implementations across the US.
The Systems Training Specialist II also works closely with IT Development teams using the SAFe Agile development methodology.
Location: Candidates must currently reside in the Eastern or Central time zones of the continental United States, with ability to travel up to 60% and reside in close proximity to a major airport. Role is Hybrid: Candidates must have the ability to travel for business to client sites, conferences, seminars, meetings &amp; trainings, etc., including to our Indianapolis, Indiana Central Office. Relocation is not available.<h2 class="jobSectionHeader">
Responsibilities
</h2>Training and Support<ul><li>Facilitate instructor-led classroom and web-based learning on proprietary business systems and processes for associates as assigned, including new customer implementations.</li><li>Ensure on-site support of new customer field system training Implementation training is accurate, engaging, and successful. Support potential follow up testing, evaluation, and training for new implementations.</li><li>Work with management to gather feedback on training effectiveness, including to: post training surveys, assessments and on the job performance checklists.</li><li>Assist with the management of the monthly new associate CORE training, including scheduling, training delivery, and materials creation and maintenance.</li><li>Oversee software training environments including; updates, readiness for training, and submit and manage defect tickets.</li><li>Build relationships with other internal departments that are dependent on training results and outcomes and report out on successes, action items and other information as needed.</li><li>Serve as a positive representative for training initiatives and acting as a catalyst to help teams understand the why and how of system changes.</li><li>Lead or participate in key initiative projects as defined by the leader of Business Operations Training.</li></ul>
Instructional Design<ul><li>Develop and maintain training curriculum and materials using Instructional Design methodologies.</li><li>Work with subject matter experts to gather content for training development.</li><li>Participate in needs assessments for training content development.</li><li>Write quality test items (question stems and distractors).</li><li>Develop and maintain job aids, presentations, and instructor and user guides.</li><li>Support the development of training for company-wide training projects as needed.</li><li>All other duties as assigned.</li></ul>
Skills and Experience<ul><li>Minimum 5 years of experience delivering software/application training required; healthcare, database, or technical systems or services industry preferred.</li><li>Experience with Instructional Design and development methodology is required (ADDIE, backwards design model, ABCD learning objectives or other similar methodologies).</li><li>Ability to work with autonomy is required, prioritizing work and balancing multiple and/or large-scale projects without supervision.</li><li>Experience using Camtasia, GoAnimate, Articulate360, or other educational multimedia production software preferred.</li><li>Experience writing instructor led webinars (scripts, user guides, interactive exercises) preferred.</li><li>Experience writing test items and distractors preferred.</li><li>Familiarity with the Kirkpatrick Model of training evaluation a plus.</li><li>Some experience with SAFe Agile software development methodology a plus.</li><li>Strong Microsoft Office skills required with ability to quickly learn new computer software.</li><li>Strong written, verbal, and presentational communication skills required.</li><li>Able to present to small (1 on 1) and large groups (100+ attendees), both in-person and virtually.</li><li>Able to present complex information to a variety of audiences while demonstrating confidence and inspiring/motivating other to perform well.</li><li>Proven ability to master the full training cycle.</li><li>Able to establish and manage relationships with stakeholders, associates, Subject Matter Experts, Leadership, and various departments.</li><li>Excellent problem solving and analytical thinking skills.</li><li>Experience with web-based conferencing such as Teams, Adobe Connect, or GoToMeeting required.</li><li>Travel up to 60% of the time required to support New Customer Implementations.</li></ul>
Education and Qualifications<ul><li>Bachelor&rsquo;s degree or equivalent in Education/Training, Healthcare Administration, or other-related field is required.</li></ul>
#LI-Hybrid
At TRIMEDX, we are committed to cultivating a workplace culture where every associate feels valued, supported, and empowered to thrive. This culture reflects our belief that our people are our foundation, their well-being is essential, and shared success is built through meaningful work, recognition, and opportunities for growth.
We embrace people&rsquo;s differences which include age, race, color, ethnicity, gender, gender identity, sexual orientation, national origin, education, genetics, veteran status, disability, religion, beliefs, opinions and life experiences.
Visit our website to view our Workplace Culture Commitment , along with our social channels to see what our team is up to: Facebook, LinkedIn, Twitter. 
TRIMEDX is an Equal Opportunity Employer. Drug-Free Workplace.
Because we are committed to providing a safe and productive work environment, TRIMEDX is a drug-free workplace. Accordingly, Associates are prohibited from engaging in the unlawful manufacture, sale, distribution, dispensation, possession, or use of any controlled substance or marijuana, or otherwise being under the influence thereof, on all TRIMEDX and Customer property or during working/on-call hours.</div>

Systems Training Specialist II

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