Clinical Research Coordinator B/C

Pennsylvania (US)
17 Nov 2018
End of advertisement period
17 Jan 2019
Contract Type
Full Time

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.

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.

The Perelman School of Medicine at the University of Pennsylvania is the oldest and one of the finest medical schools in the United States. Penn is rich in tradition and heritage and at the same time consistently at the forefront of new developments and innovations in medical education and research. Since its founding in 1765 the School has been a strong presence in the community and prides itself on educating the leaders of tomorrow in patient care, biomedical research, and medical education.

Participate in all phases of clinical research, including study design, protocol development, submission to review boards, subject recruitment and enrollment, study visits and regulatory compliance in one or more studies within the Penn Department of Medicine’s Clinical Trials Unit. Studies may be investigator-initiated or industry-sponsored Phase I-IV trials.

Clinical Research Coordinator B: Participate in and coordinate clinical trials within the Penn Department of Medicine’s Clinical Trials Unit. The person will support a diverse group of investigators, involving work on a wide spectrum of clinical trials ranging from phase I to IV, investigator and industry initiated, different disease states and varying complexities.

Involvement in trials will range from consulting to serving as the primary coordinator for a study handling all coordinator activities such as:
Assist in development of study documents. Communicate with study team members and regulatory review boards. Recruit, consent and screen patients according to protocol. Schedule patient visits and any necessary testing. Conduct patient visits. Monitor patients per protocol requirements and ensure adherence to protocol requirements. Organize and maintain all documentation required by the Investigator, sponsor or CRO, includes source documentation, case report forms, and research charts. Collect, review and report study data. Complete case report forms and resolve data queries. Process and ship study specimens including blood and urine. Participate in initiation, monitoring, audit and close-out visits.

Participate in study team meetings, and ongoing protocol training. Assist in the development/maintenance of study specific case report forms and source document tools. Show vigilance in patient safety, protocol compliance and data qualify. Adhere to all University of Pennsylvania, FDA and GCP guidelines.

The Clinical Research Coordinator C is expected to perform the duties above with more limited supervision from the project manager. In addition, will develop complex documents such as protocols and consents, lead team meetings, and may take a lead role in study communication with internal and external groups. Work directly with investigators to design, set-up and execute studies. Accountable for making sure study timelines and goals are met. Independently move a clinical trial through each phase of development, resolving issues and queries with input from a supervisor as required. Management of clinical trials and will need to use more independent judgment. 

CRC-B- Bachelor’s degree and 2 years to 4 years of experience or an equivalent combination of education and experience required.
CRC-C – Bachelor’s degree and 4years to 6 years of experience or an equivalent combination of education and experience required. 

Both positions: 
Effective problem solving abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations 

Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.