Clinical Research Coordinator B/C

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Posted Job Title

Clinical Research Coordinator B/C

Job Profile Title

Clinical Research Coordinator B

Job Description Summary

Clinical Research Coordinator B
Responsible for implementing clinical research activities within the Cardiovascular Division of PPMC
Responsible for assisting with study coordination and recruitment for industry sponsored studies. Works directly with study physicians, research director and other research staff. Major duties include screen/enroll patients, conduct follow-up assessments, data collection and use of EDC systems, assessment of adverse events. This coordinator will assist in ensuring patient and data safety, manage samples and related processing, and will be a proactive communicator with the team and its PIs.

Clinical Research Coordinator C
Responsible for implementing clinical research activities within the Cardiovascular Division of PPMC.
Responsible for assisting with study coordination and recruitment for industry sponsored studies. Works directly with study physicians, research director and other research staff. Performs screening visits, consenting of participants, processing and shipping of labs, entering data into databases, escorting participants to other testing/procedure areas.. . Coordinate several investigational device trials in the cath lab, instruct and support investigators and study staff on carrying out clinical protocol and other study related requirements.

Job Description

This position is contingent upon favorable funding.

Clinical Research Coordinator B

Job Responsibilities

• Assist in coordinating the conduct of assigned clinical trials performed by the physicians of Penn Cardiology and collaborates with principal investigators to assure research activities are conducted

   with the currently approved protocol/amendments, according to Good Clinical Practice (GCP) guidelines applicable federal and state requirements and University policies.

• Provides oversight of administration of medications, study drugs or study interventions and monitor subject care and status throughout the course of the study.

• Creates and maintains research data, regulatory files, subject data and patient tracking databases.  

• Assures reported trial data are accurate, complete and verifiable from source documents; collects data on adverse events and reports serious adverse events according to regulatory requirements.   

• Prepares all documents for IRB review including draft informed consents written for subject reading levels.

• Assist in conducting in conducting initiation, monitoring and closeout visits with sponsors  .

• Provides training and education for patient care staff in all aspects of trial initiation, conduct and closure.