Clinical Research Coordinator
About The Position
The University of Pennsylvania, a world-renowned leader in education, research, and innovation, is seeking a Clinical Research Coordinator B. This role involves conducting in-home and on-site study visits, distributing participant incentives, conducting literature reviews, assisting in interview coding, and preparing and processing all Institutional Review Board (IRB) submissions and other regulatory requirements. The coordinator will also manage documentation required by sponsors or CROs, adhere to all University of Pennsylvania, ICF, and FDA guidelines, and prepare manuscripts and findings for presentation. Additionally, the position provides administrative support for research operations and participates in weekly study progress meetings.
Requirements
- Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required
- Possessing an in-depth knowledge of the federal regulations and guidance documents for the conduct of clinical studies and human subject protection
Responsibilities
- Conduct in-home and on-site study visits
- Distribute participant incentives to participants
- Conduct literature reviews and synthesis
- Assist in coding of interviews
- Prepare and process all Institutional Review Board (IRB) submissions, including initial submissions, amendments, continuing reviews, adverse events, and serious adverse events
- Coordinate, organize, and maintain all documentation required by sponsor or CRO (case report forms, source documentation, study and regulatory binders, subject binders)
- Adhere to all University of Pennsylvania, ICF, and FDA guidelines and NIH policies
- Prepare manuscripts and findings for presentation
- Provide administrative support for research operations
- Participate in weekly study progress meetings with the PI and research team
- Manage IRB submissions and renewals in accordance with FDA and IRB guidelines
- Assure compliance with the protocol and regulatory requirements including collecting, recording, and maintaining data and source documentations
- Promote good clinical practice in the conduct of clinical investigations
- Talking to participants to determine interest in participating in research
- Verbally walking participants through consent procedures
- Administering study protocol
- Overseeing data entry in study data set
- Distributing study recruitment materials
- Traveling between study visits
- Perform additional duties as assigned
Benefits
- Excellent healthcare
- Tuition benefits for employees and their families
- Generous retirement benefits
- Wide variety of professional development opportunities
- Supportive work and family benefits
- Wealth of health and wellness programs and resources
- Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits
- Flexible spending accounts for eligible health care and dependent care expenses with pre-tax dollars
- Tuition assistance for employee, spouse, and dependent children at Penn and other institutions
- Generous retirement plans (Basic, Matching, and Supplemental) with pre-tax or Roth basis options
- Substantial amount of time away from work
- Long-Term Care Insurance
- Wellness and Work-life Resources
- Professional and Personal Development resources
- Access to a wide range of University resources as well as cultural and recreational activities
- Discounts on arts and entertainment, transportation, mortgages, cellular phone service plans, movie tickets, and theme parks
- Flexible Work Hours
- Penn Home Ownership Services (forgivable loan for eligible employees)
- Adoption Assistance
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
