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

The Clinical Research Coordinator A/B will be responsible for coordinating trial related activities to ensure the execution of the trials is adherence to the protocol and regulatory compliance; Maintaining regulatory documents per sponsor requirements, University of Pennsylvania, FDA, and GCP standards and guidelines; Preparing and participating study monitoring and audit visits; Communicating with potential patients, Pre-screening, scheduling, consenting, and enrolling patients; Making sure all the enrolled subjects have documented eligibility check list and signed appropriate version of consent; Coordinating research visits; Maintaining source documentation, Data collection and Completing CRFs; Obtaining, handling, processing, transferring /shipping of biospecimens when applicable; Tracking AE/SAE, maintaining documentation, and study logs; Coordinating with regulatory specialist when regulatory entities report is needed, such as reportable AE/SAE, Deviations; Conduct follow up phone calls to participants; includes tracking participants through the timepoints Uploading data to relevant databases; Perform data QC and address queries; Performing research billing review, subject reimbursement when applicable; Documenting all trainings and essential correspondence that related to study; Attending study related meetings and other meetings as required, Maintaining/ordering study materials as needed.
This position is contingent upon grant funding and is hybrid eligible after successful completion of intro period and 6 months of service.

Job Description

Job Responsibilities

Clinical Research Coordinator A:

Under direct supervision of senior clinical research coordinator or project manager, the primary role of Clinical Research Coordinator A is the organization, coordination and implementation of research studies. The coordinator will participate as part of a multidisciplinary team member in the care of patients on clinical research protocols. The Coordinator will assist in clinical trial coordination including: participant recruitment, data entry and QC, patient visits, tracking study progress and subject AEs, study monitoring/audit visits, perform research billing review, conduct follow up phone calls to participants; includes tracking participants through the timepoints, and assists regulatory submissions as needed.

Clinical Research Coordinator B: In addition to the above, the Clinical Research Coordinator B will be expected to effectively and independently manage multiple trials, while also assisting other coordinators as needed. The CRC B will demonstrate leadership skills within the program, be able to identify common challenges, and brain­storm creative ideas to problem-solve eme