Clinical Research Coordinator A

Clinical Research Coordinator A

This position will assist in the management of multiple clinical trials and responsibilities in Urology. Coordinate the screening of patients, subject enrollment, collection and storage of biological samples and related study documents, and collection of clinical data. Assist with Institutional Review Board (IRB) filings and inquiries, and assist in the preparation of manuscripts, grant proposals, and research related presentations. Works closely with the Principal Investigator, manager, and study team to identify problems and develop solutions. Implement approved changes to procedures as needed and monitor results. Responsible for study coordination for investigator-initiated studies, multi-center research studies, and patient-oriented clinical and translational research projects.

The day-to-day responsibilities of a CRC-A include, but are not limited to, recruitment and enrollment (i.e., pre-screening patients, explaining the study to patients and their families, consenting patients if appropriate, and confirming eligibility in conjunction with Investigators); completing case report forms (CRFs), abstracting data from electronic health records, and conducting telephone visits per protocol; maintaining contact with/tracking study participants per protocol throughout their participation; inputting data into electronic CRFs in a dedicated electronic data capture (EDC) system; responding to regulatory and operational queries in a timely manner; safety monitoring and submitting AEs, SAEs, and UADEs reports to the Investigator and Institutional Review Board (IRB) per protocol, federal, and institutional guidelines; ongoing study maintenance and oversight within institutional/study systems such as PennCTMS, PennChart, and other study platforms; regularly reporting study progress to investigators and other managers upon request; storage, and shipping/delivery of biospecimens per protocol and institutional policies; reviewing and approving research billing; organizing, maintaining, and assuring the accuracy of all study documentation including qualification materials/certifications; and preparing for and participating in study meetings.

Job Description

Job Responsibilities

• Coordinate and conduct clinical studies, includes; subject recruitment, informed consent, chart maintenance and data entry

• Coordinate IRB submissions and renewals in accordance with FDA and IRB guidelines

• Assure compliance with the protocol and regulatory requirements includes: collecting, recording, and maintaining data and source documentations.

• Oversee study preparation and blood sample processing and analysis

• Database management and analysis

• Ordering and stocking supplies, maintaining equipment

• Educate patients and family members

• 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

Qualifications

• Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required.

• This position is contingent upon grant funding.