Clinical Research Coordinator B

Job Description Summary

Renal division in the department of medicine 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 trials. 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. This position is responsible for study coordination for investigator-initiated studies, multi-center research studies, and patient-oriented clinical and translational research projects within the Renal, Electrolyte, and Hypertension Division. The position involves working directly with study physicians, research nurses, and other research staff at Penn and at other sites. He/She will recruit and perform study visits, enter data, resolve queries, obtain, process, and ship specimens. The position will help advance the research mission of the Division and University and show vigilance in patient safety, protocol compliance, and data quality. It requires adherence to all University of Pennsylvania, IRB, and FDA guidelines and may require working off site and flexible hours.

In addition, he/she 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. He/She will 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, prepare and submit regulatory packages, correspond with sponsor & regulatory review boards, and help with study start up activities Management of clinical trials and will need to use more independent judgment.

Job Responsibilities

• Screen, recruit and enroll consenting patients using Good Clinical Practice guidelines and conduct compliance monitoring of study participants.
• Conduct study related visits, including procedures such as blood draws, vitals, medical history, ECGs and processing of biological specimens and manage study data and regulatory files per GCP.
• Work with Regulatory Affairs Specialist to prepare for audits, review regulatory binders, perform internal audit and other QA activities, and handle monitor/audit visits with CROs, the FDA and other entities.
• Correspond regularly with the Institutional Review Board and other regulatory agencies, including preparation and submission of protocols, protocol amendments, SAE reports and DSMB subject narratives.
• With supervision, assist in preparation of research protocols and documents.
• With the help of the project manager, manage/coordinate/organize the daily work of research assistants for tasks such as recruitment, study visits, and regulatory, and train them in these tasks. Attend Investigator Meetings and communicate meeting information to the study team.
• Perform additional duties as assigned

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