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Posted Job Title
Clinical Research Coordinator A
Job Profile Title
Clinical Research Coordinator A
Job Description Summary
Renal division in the department of medicine supports a diverse group of investigators, involving work on a wide spectrum of clinical trials ranging from phase I to IV, investigator and industry initiated trials. This position is responsible for study coordination for investigator-initiated studies, multi-center research studies, and patient-oriented clinical and translational research projects within the Renal, Electrolyte, and Hypertension Division. The position involves working directly with study physicians, research nurses, and other research staff at Penn and at other sites. The position will help advance the research mission of the Division and University and show vigilance in patient safety, protocol compliance, and data quality. It requires adherence to all University of Pennsylvania, IRB, and FDA guidelines and may require working off site and flexible hours.
Job Description
Job Responsibilities
- Screen, recruit and enroll consenting patients using Good Clinical Practice guidelines and conduct compliance monitoring of study participants. 25% 5
- 2 Conduct study related visits, including procedures such as blood draws, vitals, medical history, ECGs, processing and shipping of biological specimens and manage study data and regulatory files per GCP. Also includes: subject recruitment, informed consent, chart maintenance and data entry.
- 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.
- Ordering and stocking supplies, maintaining equipment
- 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.
- Perform additional duties as assigned
CONTINGENT UPON FUNDING
Qualifications
- Bachelor of Science and 1 to 2 years of experience or equivalent combination education and experience is required.
- Effective problem solving abilities; effective communication and writing skills; strong organizational and time management skills; flexible and able to multi-task; demonstrated ability to work as part of a team, as well as independently; knowledge of IRB and human research protection regulations; prior experience in gene therapy trials preferred.
Job Location - City, State Philadelphia, Pennsylvania
Department / School Perelman School of Medicine
Pay Range $46,500.00 - $48,500.00 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.
Special Requirements Background checks may be required after a conditional job offer is made. Consideration of the background check will be tailored to the requirements of the job.
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