Clinical Research Coordinator A/B

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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 A/B

Job Profile Title

Clinical Research Coordinator A

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.
Assist the regulatory specialist in preparing for all local and Central Institutional Review Board (IRB) documentation through the IRB,
including submissions, continuing reviews, amendments, modifications, and adverse event reporting and all regulatory documentation
with pharmaceutical companies and clinical research organizations (CROs). Assist with creation of master trial file and obtain the appropriate signatures for the regulatory forms. The candidate must have the ability to multi-task and be flexible. Should have excellent interpersonal skills and be able to work as part of several teams. Must be able to direct his or her own work and is able to
work independently.

Job Description

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.

CRC A: With supervision, assist in preparation of so