"Clinical Research Coordinator A/B"

Clinical Research Coordinator A/B

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.

Job Description Summary

The Center for Cellular Immunotherapies (CCI) drives scientific innovation in cellular and gene therapies and fast-tracks the development of effective new treatments under one umbrella. CCI supports early, high-risk yet promising research and engagement of clinical investigators to conduct early phase trials aimed at learning how the innate and/or adaptive immune system can be used to treat cancer and other diseases.

The Clinical Trials Unit (CTU) is comprised of well-educated and trained personnel who carry out a variety of responsibilities and functions directly related to the execution of clinical trials developed within CCI. The CTU seeks to shift the paradigm for the standards of clinical research in oncology.

Within the CTU, the Clinical Research Coordinator will work with various Principal Investigators to coordinate several aspects of the research being performed for their Phase I-Phase II clinical research studies.

Job Description

Clinical Research Coordinator A

• Coordinate study visits as per protocol
• Manage collection of data from source documents pertaining to study visits and transcribe to case report form, including concomitant medications and adverse events
• Updating subject binders, source documents, calendars, enrollment logs (AKA Patient List/Patient Tracker)
• Coordinating IP administration/performing IP verification (i.e., T cell infusion, vaccine)
• Review subject binders for completeness prior to monitor/audit visits, review eCRFs for completeness & accuracy
• AE/SAE collection, reporting, reconciliation: Ensure proper reporting of serious and non-serious adverse events to the Sponsor and all applicable institutional or study related committees and personnel (e.g., IRB, DSMC, DSMB/Medical Monitor) according to applicable regulations and policies

Clinical Research Coordinator B:

The Clinical Regulatory Coordinator B will have the same duties as A but will also include the following:

• This individual can work independently
• Participate in the development of unit guidance documents
• May be responsible for orientation/mentoring of new staff

Position is Contingent upon Funding

Qualifications

• Clinical Research Coordinator A Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required.
• Clinical Research Coordinator B Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required.

The candidate must be able to work independently and be a proactive problem-solver with the ability to critically evaluate and manage timelines and key deliverables. This includes coordination with the clinical team and sponsor teams. Have a thorough knowledge of ICH-GCP regulations and comprehensive understanding of clinical trial processes preferred.

Excellent communication skills, attention to detail, organizational and time management skills, and the ability to work independently and as a team member are essential qualities for this position. The successful candidate will assure compliance with all applicable regulatory requirements, SOPs, study contracts, etc.

Job Location - City, State

Philadelphia, Pennsylvania

Department / School

Perelman School of Medicine

Pay Range

$46,500.00 - $63,500.00 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.