Clinical Research Coordinator

About This Role

This Clinical Research Coordinator role involves conducting in-home and on-site study visits, managing participant incentives, and supporting various research operations. The position is ideal for someone who can handle IRB submissions, maintain compliance with regulatory requirements, and promote good clinical practice.

Responsibilities

• Conduct in-home and on-site study visits
• Distribute participant incentives
• 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 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
• Tuition assistance for dependent children at other institutions
• Generous retirement plans (Basic, Matching, and Supplemental) with various investment options through TIAA and Vanguard