GENERAL SUMMARY/ OVERVIEW STATEMENT:
The selected candidate will work independently to coordinate clinical research projects under the direct supervision of the principal investigators, and with the support of an established team of clinical research coordinators. The candidate will be responsible for all study tasks related to Pancreatic diseases including, but not limited to various forms of pancreatitis, pancreatic cysts, and possibly pancreatic cancer. The candidate will work with members from both the gastroenterology and surgical teams along with other members of the multidisciplinary clinical and research team.
The candidate will work full time (40 hours/week) however the schedule will require flexibility and may include occasional evenings depending on time-management and patient schedules. The research studies will continue for approximately 2 years or more. This research environment is highly conducive to individuals interested in eventually pursing medical, graduate, or public health advanced degrees. There will be mentored opportunities for publication and presentation depending on the candidate's interest.
This position offers the opportunity to work directly with patients and physicians, and it will provide foundational skills in conducting clinical research in a large, academic medical center.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
• Recruit and enroll eligible study participants from clinics throughout the hospital
• Arrange and conduct initial interviews of study subjects and evaluate criteria for inclusion/exclusion
• Take subject vital signs; draw blood samples and perform sample processing
• Perform Institutional Review Board (IRB) submission process by preparing protocol applications, amendments, safety reports, adverse event reports and other documents
• Capture clinical information from record review and patient interview into study database
• Perform bio-specimen processing, aliquoting, tracking and shipping
• Keep bio-specimen electronic and physical inventories current and available
• Manage and maintain regulatory documents for audit by FDA, as needed
• Prepare and manage regulatory documents for audit by FDA, as needed
• Act as primary study resource for laboratory staff, patients and families
• Evaluate and update medical records and maintain study database
• Coordinate subject care by scheduling and arranging follow-up visits, conducting follow-up telephone calls, and communicating concerns with the study investigator
• Conduct regular review of study progress and follow-up
• Attend weekly coordinator meetings, and prepare weekly reports of work performed
The Clinical Research Coordinator II should also possess:
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