Clinical Research Coordinator A
About The Position
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. 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.
Requirements
- Bachelor of Science and 1 to 2 years of experience or equivalent combination of education and experience is required.
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
Benefits
- excellent healthcare
- tuition benefits for employees and their families
- generous retirement benefits
- wide variety of professional development opportunities
- supportive work and family benefits
- wealth of health and wellness programs and resources
- Health, Life, and Flexible Spending Accounts
- comprehensive medical, prescription, behavioral health, dental, vision, and life insurance benefits
- flexible spending accounts to pay for eligible health care and dependent care expenses with pre-tax dollars
- Tuition assistance here at Penn for employee, spouse, and dependent children
- Tuition assistance at other institutions for dependent children
- generous retirement plans
- pre-tax or Roth basis retirement savings
- wide variety of investment options through TIAA and Vanguard
- substantial amount of time away from work
- Long-Term Care Insurance
- Wellness and Work-life Resources
- Professional and Personal Development resources
- access to a wide range of University resources as well as cultural and recreational activities
- Discounts and Special Services
- Flexible Work Hours
- Penn Home Ownership Services
- Adoption Assistance
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
