Clinical Research Coordinator

Position: Clinical Research Coordinator A
University Overview

The University of Pennsylvania, the largest private employer in Philadelphia, is a world-renowned leader in education, research, and innovation. This historic, Ivy League school consistently ranks among the top 10 universities in the annual U.S. News & World Report survey. Penn has 12 highly-regarded schools that provide opportunities for undergraduate, graduate and continuing education, all influenced by Penn's distinctive interdisciplinary approach to scholarship and learning.

As an employer Penn has been ranked nationally on many occasions with the most recent award from Forbes who named Penn one of America's Best Large Employers in 2023.

Penn offers a unique working environment within the city of Philadelphia. The University is situated on a beautiful urban campus, with easy access to a range of educational, cultural, and recreational activities. With its historical significance and landmarks, lively cultural offerings, and wide variety of atmospheres, Philadelphia is the perfect place to call home for work and play.

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

Job Profile Title

Clinical Research Coordinator A

Job Description Summary

Assist in the coordination of Phase I - IV clinical trials. Complete, organize and maintain all documentation required by sponsor or Clinical Research Organizations (CROs) (i.e., case report forms and study binders) as directed by the supervisor. Conduct data entry in CRFs as provided by the study sponsor Organize study start up and generate materials to support trial workflows. Navigate eligibility criteria.

Develop recruitment strategies to poise trial for success. Minimize participant burden whenever possible through; reduction of barriers to recruitment, timely responses, answering questions, ongoing feedback, and support of concerns. Serve as an overall resource or point of contact for individuals interested in clinical trials. Resolve data queries with sponsor and CROs. Ensure data monitoring accuracy. Recruit, screen and enroll potential study subjects as specified per protocol.

Utilize the EMR to support and operationalize clinical research. Provide study related metrics and tracking. Participate in the conduct of audits by study sponsors, CROs, the FDA, and other entities as required. Process and ship blood, urine, and serum specimens for each trial. Schedule patient visits and any necessary testing. Attend Investigator Initiation meetings. Obtain slides from pathology and ship to sponsor/independent review per protocol guidelines.

Obtain records required to complete case report forms. Assist in the preparation of documents needed for initiation, monitoring and closeout visits with sponsors and/or CROs. Show vigilance in patient safety, protocol compliance, and data quality. Adhere to all University of Pennsylvania, informed consent form (ICF), and FDA guidelines. Assist PI with presentations and publications

Job Description

Job Responsibilities

Assist in the coordination of Phase I - IV clinical trials

Complete, organize and maintain all documentation required by sponsor or Clinical Research Organizations (CROs) (i.e., case report forms and study binders) as directed by the supervisor

Conduct data entry in CRFs as provided by the study sponsor

Organize study start up and generate materials to support trial workflows

Navigate eligibility criteria

Develop recruitment strategies to poise trial for success

Minimize participant burden whenever possible through; reduction of barriers to recruitment, timely responses, answering questions, ongoing feedback, and support of concerns

Serve as an overall resource or point of contact for individuals interested in clinical trials

Resolve data queries with sponsor and CROs

Ensure data monitoring accuracy

Recruit, screen and enroll potential study subjects as specified per…