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The Pancreatic Research Program is dedicated to discovering and characterizing the disease mechanisms for pancreatitis so that effective treatments can be developed. Basic and translational research efforts at the Pancreatic Research Program are designed to advance clinical care delivery to our patients.
The Clinical Research Coordinator I works independently providing study coordination in support of the Pancreatic Research Program’s multidisciplinary team’s larger goal of enhancing treatments and outcomes for pancreatic cancer, pancreatitis and diabetes patients. Duties will include, screening of potential patients for protocol eligibility, presenting non-medical trial concepts and details, and participating in the informed consent process. The incumbent will be responsible for accurate and timely source documents, data collection, documentation, entry, and reporting including timely response to sponsor queries. This position presents this information at research staff meetings and ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB).
Primary Duties and Responsibilities:
- Schedules research visits and procedures for enrolled participants.
- In collaboration with the physician and other medical personnel, documents thoroughly on Case Report Forms (CRFs) the following; changes in research participant condition, adverse events, concomitant medication use, protocol compliance, response to study drug.
- Maintains accurate source documents related to all research procedures.
- Responsible for compiling and reporting on each study including information related to protocol activity, accrual data, workload, and other research information.
- Notifies direct supervisor about concerns regarding data quality and study conduct.
- Schedules and participates in monitoring and auditing activities.
- Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events, protocol deviations, and Safety Letters in accordance with local and federal guidelines.
- May perform other regulatory / Institutional Review Board duties, budgeting duties, and assisting with patient research billing and reconciliation.
- Maintains research practices using Good Clinical Practice (GCP) guidelines.
- Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
- Participates in required training and education programs.
- Verifies specimen identification, assesses appropriateness of test orders and quality of specimen by recognizing factors that affect procedures and results; takes appropriate action when corrections are indicated.
- Identifies patients and patient samples by strict adherence to established procedures.
- Labels samples accurately and completely.
- Reports test results to appropriate individuals and exercises professional discretion with patient information.
- High School Diploma/GED is required.
- Bachelor’s or Master’s degree is preferred.
- SOCRA or ACRP certification is preferred.
- One year of clinical research or coordinating clinical research trials experience is required.
Able to perform moderate lifting. Able to sit, stand and walk for prolonged periods of time. Able to read papers and online documents. Able to operate standard office equipment. Able to exercise physical ability and perspective acuity to satisfactorily perform essential job functions.
Working Title: Clinical Research Coordinator I – Pancreatic Research Program
Department: Home Dept – Medicine Research
Business Entity: Academic / Research
Job Category: Academic/Research
Job Specialty: Research Studies/Clinical Trials
Position Type: Full-time
Shift Length: 8 hour shift
Shift Type: Day
Base Pay:$23.39 – $39.76