Research - Laboratory/Non-Laboratory, Research Support - Laboratory/Non-Laboratory, Staff/Administrative
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Posted Job Title
Clinical Research Coordinator A
Job Profile Title
Clinical Research Coordinator A
Job Description Summary
The research coordinator will support various research activities of the Penn Cystic Fibrosis Research group. They will participate in all phases of clinical research, including study design, protocol development, submission to review boards, subject recruitment and enrollment, study visits and regulatory compliance in one or more studies. The coordinator will be primarily responsible for the planning, conduct, and management of an investigator-initiated prospective observational study involving data and biospecimen collection and analysis. Participate in all phases of clinical research, including study design, protocol development, submission to review boards, subject recruitment and enrollment, study visits and regulatory compliance in one or more studies within the Penn Department of Medicine's Clinical Trials Unit. Studies may be investigator-initiated or industry-sponsored Phase I-IV trials.
This position will assist in the management of multiple clinical trials and responsibilities in specific research area. 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.
Participate in and coordinate clinical trials within the Penn Department of Medicine Clinical Trials Unit. The person will support a diverse group of investigators, involving work on a wide spectrum of clinical trials ranging from phase I to IV, investigator and industry initiated, different disease states and varying complexities. Involvement in trials will range from consulting to serving as the primary coordinator for a study handling all coordinator activities such as:
Assist in development of study documents. Work with Regulatory Specialist for regulatory submissions. Communicate with study team members. Recruit, consent and screen patients according to protocol. Schedule patient visits and any necessary testing. Conduct patient visits. Monitor patients per protocol requirements and ensure adherence to protocol requirements. Organize and maintain all documentation required by the Investigator, sponsor or CRO, including source documentation, case report forms, and research charts. Collect, review and report study data. Complete case report forms and resolve data queries. Process and ship study specimens including blood and urine. Participate in initiation, monitoring, audit and close-out visits. Participate in study team meetings, and ongoing protocol training.Â Assist in the development/maintenance of study specific case report forms and source document tools. Show vigilance in patient safety, protocol compliance and data qualify. Adhere to all University of Pennsylvania, FDA and GCP guidelines.
This position is contingent on funding.
Qualifications Bachelor's Degree with 1-3 years of related experience in research and clinical study methodologies or equivalent.combination of education and experience is required.
Working Conditions Office, Library, Computer Room; Requires extensive safety
Physical Effort Typically sitting at a desk or table; Occasional lifting 25 lb. or less
Job Location - City, State
Department / School
Perelman School of Medicine
$36,401.00 - $65,521.00
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.
Special Requirements Background check required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
Internal Number: JR00015096
About University of Pennsylvania
Penn has a long and proud tradition of intellectual rigor and pursuit of innovative knowledge, begun by Benjamin Franklin in 1740. That tradition lives today through the creativity, entrepreneurship, and engagement of our faculty, students, and staff. Academic life at Penn is unparalleled, with an undergraduate student body of 10,000 from every U.S. state and around the world. The entering class of 2015 is the most talented and diverse in Penn's history. Consistently ranked among the top 10 universities in the country, Penn welcomes an additional 10,000 students to our top-ranked graduate and professional schools.