Clinical Research Coordinator B

Requirements

• Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required.
• Position is contingent upon continued funding.
• Job Location - City, State
• Philadelphia, Pennsylvania
• Department / School
• Perelman School of Medicine
• Pay Range
• $53,418.00 -

Benefits

Additional Information

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 B Job Profile Title Clinical Research Coordinator B Job Description Summary Manages phases of complex clinical trials under general supervision, ensuring compliance with good clinical practice. Oversees study operations, mentors junior staff, and contributes to budget preparation and expense management for multi-center trials. Coordinates with partnering institutions, supports monitoring of external sites, and participates in study and protocol training meetings. Job Description Job Responsibilities Prepare and process all Institutional Review Board (IRB)through the IRB and other regulatory groups as apropriate 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) Assist in the coordination of Phase I-IV clinical trials Participate in the conduct of study audits by sponsors,CRO's, the FDA and other entities as required. Participate in the conduct of study audits by sponsors, CRO's, the FDA and other entities as required. Schedule patient visits and any necessary testing. Adhere to all University of Pennsylvania, ICF, and FDA guidelines. Process and ship blood, urine and tissue as required per trial Conduct initiation, monitoring and closeout visits with sponsors and/or CROs Ensure proper screening and enrollment of all study participants, including administering informed consent and confirming subject study eligibility prior to participation, Ensure proper reporting of serious and non-serious adverse events to the Sponsor and all applicable institutional or study related committees and personnel (e.g., IRB, DSMC, DSMB/Medical Monitor) according to applicable regulations and policies, Coordinate the administration of the investigational product and study related medications including obtaining orders, scheduling administration dates, administration of investigational and study related medications (as applicable), monitoring subjects for post-administration adverse events or reactions, Manage scheduling and coordination of subject study specified treatment, follow-up visits and procedures, Meet with Principal Investigator routinely to discuss study related issues and to ensure completion of study related procedures (e.g., determination of causality for adverse events, deviation/exception requests), Manage collection of data from source documents pertaining to study visits and transcribe to case report form, including concomitant medications and adverse events, Ensure preparation of study related document templates (e.g., visit guides, source document templates), subject study binders, regulatory binders (hard and electronic version), patient list (enrollment log) for study start up, Ensure preparation of all required study related documents for submission to all applicable PENN institutional committees for review and approval to start trial (e.g., IRB, CTSRMC), Assist with protocol development to ensure logistical feasibility of all study related procedures and study work-flow, Other duties and responsibilities as assigned. Other duties and responsibilities as assigned

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