Bachelor of Science and 2 to 3 years of experience or equivalent combination of education and experience is required.
Clinical Research Coordinator C
Job Responsibilities
Screen, recruit and enroll consenting patients using Good Clinical Practice guidelines and conduct compliance monitoring of study participants.
Conduct study related visits, including procedures such as blood draws, vitals, medical history, ECGs and processing of biological specimens and manage study data and regulatory files per GCP.
Work with Regulatory Affairs Specialist to prepare for audits, review regulatory binders, perform internal audit and other QA activities, and handle monitor/audit visits with CROs, the FDA and other entities.
Correspond regularly with the Institutional Review Board and other regulatory agencies, including preparation and submission of protocols, protocol amendments, SAE reports and DSMB subject narratives.
Work with primary investigators to develop investigator-initiated protocols, case report forms and databases. Independently design research documents including consent forms, source documents, CRFs and training SOPs.
A CRC C will be expected to do this independently.
Other duties and responsibilities as assigned
Bachelor of Science and 4 to 6 years of experience or equivalent combination of education and experience is required.
The position is contingent upon grant fundi
Benefits
Health insuranceVision insurance
Additional Information
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 B/C
Job Profile Title
Clinical Research Coordinator B
Job Description Summary
The responsibilities of this position will be to provide assistance and oversight with single-center and multi-center clinical research trials conducted within the Cardiovascular Medicine Division of the University of Pennsylvania. This position will support specific specialty sections in Cardiology and will require coordinating efforts within the Division with collaborating sites and external institutions, involving work on a wide spectrum of clinical trials ranging from phase I to IV, investigator and industry initiated, different interventions and varying complexities. Research coordinator work includes study design, protocol development, submission to review boards, subject recruitment and enrollment, study visits and regulatory compliance in one or more studies.
Job Description
This position is contingent upon favorable funding.
Clinical Research Coordinator B
Job Responsibilities
Screen, recruit and enroll consenting patients using Good Clinical Practice guidelines and conduct compliance monitoring of study participants.
Conduct study related visits, including procedures such as blood draws, vitals, medical history, ECGs and processing of biological specimens and manage study data and regulatory files per GCP.
Work with Regulatory Affairs Specialist to prepare for audits, review regulatory binders, perform internal audit and other QA activities, and handle monitor/audit visits with CROs, the FDA and other entities.
Correspond regularly with the Institutional Review Board and other regulatory agencies, including preparation and submission of protocols, protocol amendments, SAE reports and DSMB subject narratives.
With supervision, assist in preparation of research protocols and documents.
With the help of the project manager, manage/coordinate/organize the daily work of research assistants for tasks such as recruitment, study visits, and regulatory, and train them in these tasks. Attend Investigator Meetings and communicate meeting information to the study team.
Other duties and responsibilities as assigned
Upenn · Perelman Center-fl11