"Clinical Research Coordinator A"

Posted Job Title

Clinical Research Coordinator A

Job Profile Title

Clinical Research Coordinator A

Job Description Summary

This position will support clinical and translational research studies led by the Susztaklab, including multi-site investigator-initiated projects such as Trident, PGDD, and KRAD. The role involves day-to-day coordination of study activities, including subject recruitment, data collection, regulatory documentation, and communication with internal and external collaborators.

The individual will work closely with study physicians, research nurses, and staff at Penn and partner institutions to ensure high-quality execution of research protocols. Attention to patient safety, data integrity, and regulatory compliance is essential.

This position requires adherence to University of Pennsylvania, IRB, and FDA guidelines, and may occasionally involve off-site work or flexible hours, depending on study needs.

Job Description

This position will assist in the management of multiple clinical trials and responsibilities in specific research area. 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.

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.

Effective problem solving abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations; prior experience in gene therapy trials preferred

This position is contingent upon funding

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$46,500.00 - $46,500.00 Annual Rate

Salary offers are made based on the candidate’s qualifications, experience, skills, and education as they directly relate to the requirements of the position, and in alignment with salary ranges based on external market data for the job’s level. Internal organization and peer data at Penn are also considered.

Equal Opportunity Statement

The University of Pennsylvania is an equal opportunity employer. Candidates are considered for employment without regard to race, color, sex, sexual orientation, religion, creed, national origin (including shared ancestry or ethnic characteristics), citizenship status, age, disability, veteran status or any class protected under applicable federal, state or local law.

Special Requirements

Background checks may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.