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 Responsibilities
- Screen, recruit and enroll consenting patients using Good Clinical Practice guidelines and conduct compliance monitoring of study participants. 25% 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
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
Philadelphia, Pennsylvania
Department / School
Perelman School of Medicine
Pay Range
$46,500.00 - $48,500.00 Annual Rate
CONTINGENT UPON FUNDING
To apply
Unlock this job opportunity
View more options below
View full job details
See the complete job description, requirements, and application process
