• Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.
• Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
• Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.
• Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
• Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses.
• Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
• Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions.
• Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
• Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.
• Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.
• Code, evaluate, or interpret collected study data.
• Participate in preparation and management of research budgets and monetary disbursements.
• Participate in the development of study protocols including guidelines for administration or data collection procedures.
• Instruct research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures.
• Communicate with laboratories or investigators regarding laboratory findings.
• Review scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues.
• Order drugs or devices necessary for study completion.
• Confer with health care professionals to determine the best recruitment practices for studies.
• Collaborate with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.
• Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols. Perform specific protocol procedures such as interviewing subjects, taking vital signs, and performing electrocardiograms.
• Dispense medical devices or drugs, and calculate dosages and provide instructions as necessary.
• Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data.
• Inform patients or caregivers about study aspects and outcomes to be expected.
• Direct the requisition, collection, labeling, storage, or shipment of specimens.
• Register protocol patients with appropriate statistical centers as required.
• Interpret protocols and advise treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics.
• Arrange for research study sites and determine staff or equipment availability.
• Contact outside health care providers and communicate with subjects to obtain follow-up information.
• Contact industry representatives to ensure equipment and software specifications necessary for successful study completion.
• Solicit industry-sponsored trials through contacts and professional organizations.
• Organize space for study equipment and supplies.
• Develop advertising and other informational materials to be used in subject recruitment.