Clinical Research Coordinator A/B/C

University of Pennsylvania Perelman School of Medicine

3d•Onsite

About The Position

The Clinical Research Coordinator A/B/C will support the coordination and execution of clinical research studies within the Division of Cardiovascular Medicine at the University of Pennsylvania. This role will assist with single-center and multi-center clinical trials ranging from Phase I–IV, including investigator-initiated, federally funded, and industry-sponsored studies of varying complexity. Responsibilities include study coordination, regulatory support, subject recruitment and enrollment, study visits, data collection and management, and ensuring compliance with institutional, sponsor, and regulatory requirements. The CRC A level will work under close supervision, while the CRC B and C levels will assume increasing independence, responsibility, and oversight of more complex research activities and workflows.

Requirements

Clinical Research Coordinator A: Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required.
Clinical Research Coordinator B: Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required.
Clinical Research Coordinator C: Bachelor of Science and 4 to 6 years of experience or equivalent combination of education and experience is required.

Responsibilities

Screen, recruit, consent, and enroll research participants in accordance with study protocols, Good Clinical Practice (GCP) guidelines, and institutional requirements.
Conduct ongoing participant follow-up and compliance monitoring throughout study participation.
Conduct study-related visits and research procedures, including collection of medical history, vital signs, ECGs, specimen collection and processing, and other protocol-required activities.
Maintain accurate study documentation, source records, study data, and regulatory files in compliance with GCP, sponsor, and institutional requirements.
Collaborate with Regulatory Affairs staff and study teams to prepare for sponsor, CRO, FDA, and internal audits or monitoring visits.
Assist with review and maintenance of regulatory binders, quality assurance activities, and resolution of monitoring findings and data queries.
Assist with preparation and submission of regulatory documents to the Institutional Review Board (IRB), sponsors, and other regulatory entities, including protocols, amendments, continuing reviews, adverse event reporting, and study-related correspondence.
May assist with training research support staff on study-specific procedures and workflows (CRC A).
Attend investigator meetings and communicate relevant study updates to the research team.
With supervision, assist with preparation and maintenance of source documents, study trackers, research records, and study-specific tools (CRC A).
With guidance from leadership, assist with coordination and organization of research support staff activities related to recruitment, study visits, regulatory maintenance, and data collection (CRC B).
With limited supervision, develop and maintain source documents, study trackers, case report forms, consent documents, and other moderately complex study materials and tools (CRC B).
Independently develop, maintain, and oversee complex study documents, operational workflows, trackers, consent forms, and study management tools, and assist with protocol implementation and study execution activities (CRC C).
May provide day-to-day operational guidance, mentorship, and training to junior coordinators or research support staff, assist with workflow oversight, and lead study-related communications and meetings as appropriate (CRC C).
Other duties and responsibilities as assigned.

Benefits

Excellent healthcare and 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
Tuition assistance for employees, spouses, and dependent children
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, cultural and recreational activities
Discounts on arts and entertainment, transportation, mortgages, new cars, cellular phone service plans, movie tickets, and theme parks
Flexible work options
Home Ownership Services (forgivable loan for eligible employees)
Adoption Assistance