Clinical Research Coordinator
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.
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.
Job Description Summary
This position's primary function is to facilitate, promote, and ensure good clinical practice in the conduct of all research protocols in the Department/Center. Independently manages different phases of complex clinical trials and mentors Coordinators and Research Assistants. Works with partnering institutions and creates multi-center budgets and manages expenses. Participates in study team meetings, disease site group meetings, and ongoing protocol training/compliance meetings. Supports in the monitoring of external sites and assists in the management of multi-site trials. Adheres to all University and other regulatory guidelines.
The coordinator assists with clinical research on inherited blinding disorders. He/She will carry out mobility tests of vision as part of natural history studies and interventional clinical trials for study patients. He/She will run test validation studies. Coordinator will be responsible for writing and updating the protocols, carrying out testing procedures, and maintaining regulatory documents for gene therapy human clinical trials. The coordinator will also be responsible for reviewing the raw data for consistency and compliance with standard operating procedures. The coordinator may be asked to expedite collection of materials for genotyping and transfer of those materials between facilities. The coordinator may also carry out specific additional clinical tests for study patients.
- Coordinate the conduct of mobility testing protocols for Phase I-IV clinical trials including scheduling and arranging subject visits, coordinating the testing procedures and carry out test procedures with minimal supervision
- Carry out designated retinal/visual function tests (visual acuity, visual fields, questionnaire completion) and complete the relevant source documentation and case report forms.
- Participate in the conduct of audits by study sponsors, CRO's, the FDA and other entities as required and adhere to University of Pennsylvania, ICF, and FDA guidelines
- Conduct initiation, monitoring and closeout visits with sponsors and/or CROs.
- Enter data into case report forms, assist in purification, storage and analysis of human clinical samples, and organize and maintain all documentation required by sponsor or CRO (source documentation, case report forms, study and regulatory binders, and patient binders or electronic records)
- Resolve data queries with sponsor and CROs
- Recruit, screen and enroll potential study patients as specified per protocol and show vigilance in patient safety, protocol compliance and quality data while communicating information to the subjects and their families
- Process and ship biologic samples for each trial and interface with the Ophthalmic induced pluripotent stem cell (iPSC) facility and genotyping facilities
- Train additional personnel how to carry out mobility tests and/or retinal/visual function tests and carry out trouble-shooting and maintenance of equipment
- Review raw data sets to monitor compliance with standard operating procedures and equipment reliability
- Carry out maintenance of equipment and software and trouble-shoot and fix the equipment when there is evidence of malfunction
- Perform additional duties as assigned.
Bachelor's Degree and 2-4 years of related experience in research and clinical study methodologies or an equivalent combination of education and experience required.
Office, Library, Computer Room; Requires extensive safety
Typically sitting at a desk or table; Occasional lifting 25 lb. or less
Position is contingent on grant funding.
Job Location - City, State
Department / School
Perelman School of Medicine
$42,953.00 - $77,315.00
Affirmative Action Statement
Penn adheres to a policy that prohibits discrimination on the basis of race, color, sex, sexual orientation, gender identity, religion, creed, national or ethnic origin, citizenship status, age, disability, veteran status, or any other legally protected class.
Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.