Clinical Research Coordinator A/B/C

University Overview 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, all influenced by Penn''s distinctive interdisciplinary approach to scholarship and learning. As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America''s Best Large Employers in 2023. Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play. The University offers a competitive benefits package that includes excellent healthcare and tuition benefits for employees and their families, generous retirement benefits, a wide variety of professional development opportunities, supportive work and family benefits, a wealth of health and wellness programs and resources, and much more. Posted Job Title Clinical Research Coordinator A/B/C Job Profile Title Clinical Research Coordinator A Job Description Summary 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 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. Job 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. Clinical Research Coordinator A: May assist with training research support staff on study-specific procedures and workflows. 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. Clinical Research Coordinator B: With guidance from leadership, assist with coordination and organization of research support staff activities related to recruitment, study visits, regulatory maintenance, and data collection. Attend investigator meetings and communicate updates to the study team. With limited supervision, develop and maintain source documents, study trackers, case report forms, consent documents, and other moderately complex study materials and tools. Clinical Research Coordinator C: 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. 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. Other duties and responsibilities as assigned. Qualifications Clinical Research Coord #J-18808-Ljbffr Technical University of Denmark