Clinical Research Coordinator B/C

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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.

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. 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.

Job Responsibilities (B)

• 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 initiation, monitoring and closeout visits with sponsors.
• Provides training and education for patient care staff in all aspects of trial initiation, conduct and closure.
• Serves as primary contact for subjects, sponsors and staff of research related University offices and hospital departments in nursing, pharmacy, billing, medical records related to assign studies.
• Travel to attend investigator's meeting presented by study sponsors.

Qualifications (B)

Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required.

Job Responsibilities (C)

• Identify and recruit study subjects - screen regularly to identify potential patients for specific studies and determine patient eligibility by communicating with physicians, clinical staff, and by reviewing medical data.
• Data entry - complete source documents and worksheets and complete and/or enter all clinical record forms (CRFs) in a timely manner.
• Organize and coordinate study procedures - schedule study visits within protocol designated time frames.
• Sample processing - process, label, and store human subject blood samples according to study protocol.
• Follow-up telephone calls/interview - conduct study visits, including administering questionnaires, escorting patients to protocol-required tests and procedures.
• Assist with completing and maintaining regulatory correspondence under the direction of research director.
• Provide subject and family education and support.
• Assist interventionalists in investigational device trials, device dispensing/accountability.
• Provide in service training and education to PPMC inpatient/cath lab cardiology nurses.
• Support and train new research coordinator.
• Review all new trials in the cath lab to help identify the challenges and implement a plan to solve the challenges.

Qualifications (C)

Bachelor of Science and 4 to 6 years of experience or equivalent combination of education and experience is required.