Clinical Research Coordinator A/B

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Posted Job Title

Clinical Research Coordinator A/B

Job Profile Title

Clinical Research Coordinator A

Job Description Summary

The Clinical Research Coordinator A/B in the department of Radiation Oncology coordinates investigator-initiated and sponsored clinical trials involving radiation therapy; ensuring strict adherence to study protocols; regulatory requirements, and radiation safety standards. This role supports patient enrollment, scheduling and follow-up, data collection, and regulatory documentation while collaborating closely with the CRU team.
Position is contingent upon funding.
This position is hybrid eligible after successful completion of intro period and 6 months of service.

Job Description

Job Responsibilities

Clinical Research Coordinator A

• 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

• Promote good clinical practice in the conduct of clinical investigations, included possessing an in-depth knowledge of the federal regulations and guidance documents for the conduct of clinical studies and human subject protection

• Other duties and responsibilities as assigned

Clinical Research Coordinator B

In addition to above, the CRC-B 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