About This Role
This Clinical Research Coordinator B role involves a variety of tasks related to clinical studies, from conducting in-home and on-site visits to managing regulatory submissions and providing administrative support. The position suits a professional who can ensure compliance with guidelines while also engaging with study participants.
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 and other regulatory groups as appropriate, 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, including possessing an in-depth knowledge of the federal regulations and guidance documents for the conduct of clinical studies and human subject protection
- Talk to participants to determine interest in participating in research
- Verbally walk participants through consent procedures
- Administer study protocol
- Oversee data entry in study data set
- Distribute study recruitment materials
- Travel between study visits
- Perform additional duties as assigned
Requirements
- Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required
Benefits
- Comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits
- Flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars
- Tuition assistance for employees, spouses, and dependent children at Penn and other institutions
- Generous retirement plans (Basic, Matching, and Supplemental) with pre-tax or Roth options through TIAA and Vanguard
- Substantial amount of time away from work
- Long-term care insurance in partnership with Genworth Financial (no proof of good health for new hires; eligible family members subject to underwriting)
- Wide variety of wellness and work-life programs and resources
- Array of professional and personal development resources
- Access to University resources, cultural, and recreational activities (libraries, athletic facilities, arboretum, art galleries, museums, Annenberg Center, Penn Relays)
- Discounts and special services (arts, entertainment, transportation, mortgages, new cars, cellular phone service, movie tickets, theme parks)
- Flexible work options, including non-traditional work hours, locations, and/or job structures
- Forgivable loan for eligible employees interested in buying a home or currently residing in West Philadelphia, usable for closing costs or home improvements
- Reimbursement for qualified expenses in connection with the legal adoption of an eligible child, for up to two adoptions in your household
Important Details
- Position is contingent on funding
- Background checks may be required after a conditional job offer is made
About the Company
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 & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate, and continuing education. Penn has been named one of America’s Best Large Employers in 2023 by Forbes. The University offers a unique working environment within the city of Philadelphia on a beautiful urban campus.
