"Clinical Research Coordinator A/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.

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 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 source documents and study trackers.
• CRC B: With supervision, assist in preparation of source documents, case report forms, study trackers, protocols and consent forms, and other moderately complicated study documents.
• CRC A will not oversee research assistants but may train the assistants on their study. Attend Investigator Meetings and communicate meeting information to the study team.
• CRC B: 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.
• CRC A: Participate in and coordinate clinical trials within the renal division. 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. 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/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.
• CRC B, in addition to 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.
• Perform additional duties as assigned.

CONTINGENT UPON FUNDING

Qualifications

• CRC A - Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required.
• CRC B - Bachelor's degree required and 2-4 years of related experience or equivalent combination of education and experience is required.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$46,500.00 - $55,000.00 Annual Rate