"Clinical Research Coordinator B (Department of Endocrinology, Diabetes and Metabolism)"

Clinical Research Coordinator B (Department of Endocrinology, Diabetes and Metabolism)

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.

Job Description Summary

This position will assist in the management of clinical trials and responsibilities in specific research area. Coordinate the screening of patients, subject enrollment, collection and storage of biological samples and related study documents, and collection of clinical data. Assist with Institutional Review Board (IRB) filings and inquiries, and assist in the preparation of manuscripts, grant proposals, and research related presentations. Works closely with the Principal Investigator, manager, and study team to identify problems and develop solutions. Implement approved changes to procedures as needed and monitor results. Responsible for study recruitment and coordination/conduction of study events.

Job Responsibilities

• 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 related medications including obtaining orders, scheduling administration dates, 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)
• 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 doc.(e.g., visit guides, source document templates), subject study binders, regulatory binders (hard and electronic version), 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

Qualifications

Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required.

This position is contingent upon funding.

Job Location - City, State: Philadelphia, Pennsylvania

Department / School: Perelman School of Medicine

Pay Range: $52,500.00 - $52,661.00 Annual Rate