Clinical Research Coordinator A/B (Department of Cardiovascular Surgery)

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Posted Job Title

Clinical Research Coordinator A/B (Department of Cardiovascular Surgery)

Job Profile Title

Clinical Research Coordinator A

Job Description Summary

CRC A: The clinical research coordinator will be responsible for data entry, organizing, maintaining, and assuring the accuracy of all study documentation. The coordinator will oversee 2 or more clinical trial ensuring that the integrity of the protocol is maintained, all data and queries are answered in a timely manner, appropriate AEs and SAEs are reported to the sponsor and IRB per protocol. The CRC will participate in clinic to explain the trial to the patient and family, enroll and consent patients and complete any follow-up or research activity required. All communication with the participant or on behalf of the participant must be documented in PennChart. The CRC will be responsible for gather the data per the protocol and bring any adverse events to the attention of the PI or any other part of the research team that the PI delegates the task. The CRC will work closely with the administrative assistant to ensure that study visits are scheduled along with the appropriate studies according to the protocol. The CRC will conduct phone interviews if necessary. The CRC must complete relevant training to function in the role including electronic databases, processing and shipping specimens and phlebotomy. The CRC will maintain all mandatory trainings required to oversee and manage the trials which they are the lead CRC or backup CRC. The CRC will report directly to the Project Manager or the program Supervisor. The CRC must be sufficiently knowledgeable about Microsoft word, Excel, and other standard programs. The CRC must maintain professionalism and follow the guidelines of the institution.

CRC B: The CRC B will have all of the same responsibilities as a CRC A with added responsibilities and better knowledge base of clinical research. A CRC B is expected to manage 5 or more clinical trials. The CRC B will be well versed in Good Clinical Practice. The CRC B will have experience in managing all aspects of a trial including trial start-up, creating consents, IRB submissions, recruitment, enrollment, AE management, investigational and drug management, data entry, resolution of queries, strategies to maintain compliance and closeout of a trial. The CRC B will be able to effectively manage multiple trials and assist in aspects of other trials. The CRC B will demonstrate leadership skills within the program and be able to identify common challenges and brain-storm creative ideas to problem-solve issues.
The CRC will update the PI and Subs of all protocol modifications, AEs, SAEs and deviations related to the protocol. The CRC will document education and notification of p