Job Description

As part of the Department of Medicine, the DOM Clinical Trials Unit supports 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. Research coordinator work includes study design, protocol development, submission to review boards, subject recruitment and enrollment, study visits and regulatory compliance in one or more studies.

Clinical Coordinator A

Participate in and coordinate clinical trials within the Penn Department of Medicine Clinical Trials Unit. Assist in development of study documents. Work with Regulatory Specialist for regulatory submissions. Communicate with study team members. 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 and 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.

Clinical Coordinator B

In addition to the above, will develop study specific source documents and trackers, prepare and submit regulatory packages, correspond with sponsor & regulatory review boards, and help with study start-up activities. The CRC B will have less supervision in the management of clinical trials and will need to use more independent judgment.

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.

Qualifications

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

Position is contingent upon continued funding

CRC-A

• Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required.

CRC-B

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

CRC-C

• Bachelor of Science and 4 to 6 years of experience or equivalent combination of education and experience is required.