Clinical Research Coordinator I

Specific duties include:

• Complete all required hospital, sponsor and protocol training including phlebotomy and proper shipping, handling and transporting of human bio-samples.
• Ensure thorough familiarity with study protocols and manual of procedures.
• Participate in ongoing education in clinical research through the hospital offered programs.
• Recruit research participants.
• Obtain informed consent.
• Serve as a contact for participants/potential participants prior to enrollment and throughout the duration of the study.
• Coordinate initial and follow-up study visits (i.e. scheduling, collecting and organizing data, data entry, maintaining the study database, responding to edits and queries, and coordinating the schedules of staff members and off-site facilities).
• Administer questionnaires, set up files and paperwork, and ensure accurate/compliant records for each study visit.
• Gather measurements such as height, weight, blood pressure, and others as needed per study protocol.
• Communicate with the PI and study team regarding all aspects of the recruitment, enrollment, and the implementation of the research protocol.
• Collect and process human samples including blood, urine, and other tissues (as applicable)
• Learn and perform phlebotomy and other study procedures.
• Manage laboratory space including supply ordering, equipment maintenance and freezer sample inventory.
• Ship blood, urine and tissue samples in accordance with established procedures.
• Review data to ensure completeness and accuracy of information and follow up with staff or participants as needed to resolve problems or obtain clarification.
• Interact with regulatory agencies such as the IRB and/or sponsors and complete necessary filings; assemble and maintain regulatory binders.
• Schedule and coordinate study meetings; draft agendas and minutes.
• Request, process, and track purchase orders, checks, and invoices.
• Track inventory, order supplies, maintain staff files for training/regulatory matters, process travel reimbursement for study visits.
• Prepare and mail correspondence, maintain supplies and stock, and check temperature logs for refrigeration systems.
• Foster positive interactions with patients, participants, families and clinic staff.
• Adhere strictly to all HIPAA regulations and institutional patient confidentiality requirements.
• Attend staff meetings, answer main phone line as needed, and other duties as assigned by manager.
• Participate in literature review and scientific writing.
• Other responsibilities as assigned.

Working Conditions:

Laboratory, clinical research office, ambulatory clinical practice, and inpatient clinical setting. The research coordinator will be interacting with participants in a number of environments handling, processing, and shipping biological specimens including, blood urine and tissue samples and will be required to follow universal precautions for said specimens. Position includes assisting with participant visits in the research center, outpatient practice, inpatient hospital units, and in off-site locations.