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