Basic Job Description:
Plan, direct, or coordinate clinical research projects. Direct the activities of workers engaged in clinical research projects to ensure compliance with protocols and overall clinical objectives. May evaluate and analyze clinical data.
1) Participate in preparation and management of research budgets and monetary disbursements.
2) Inform patients or caregivers about study aspects and outcomes to be expected.
3) Code, evaluate, or interpret collected study data.
4) Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.
5) Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.
6) Communicate with laboratories or investigators regarding laboratory findings.
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7) Solicit industry-sponsored trials through contacts and professional organizations.
8) Order drugs or devices necessary for study completion.
9) Direct the requisition, collection, labeling, storage, or shipment of specimens.
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10) Arrange for research study sites and determine staff or equipment availability.
11) Review scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues.
12) Register protocol patients with appropriate statistical centers as required.
13) Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
14) Perform specific protocol procedures such as interviewing subjects, taking vital signs, and performing electrocardiograms.
15) Interpret protocols and advise treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics.
16) Develop advertising and other informational materials to be used in subject recruitment.
17) Contact industry representatives to ensure equipment and software specifications necessary for successful study completion.
18) Confer with health care professionals to determine the best recruitment practices for studies.
19) Organize space for study equipment and supplies.
20) Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.
21) Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.
22) Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.
23) Prepare study-related documentation such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, and progress reports.
24) Participate in the development of study protocols including guidelines for administration or data collection procedures.
25) Oversee subject enrollment to ensure that informed consent is properly obtained and documented.
26) Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data.
27) Instruct research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures.
28) Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions.
29) Dispense medical devices or drugs, and calculate dosages and provide instructions as necessary.
30) Contact outside health care providers and communicate with subjects to obtain follow-up information.
31) Collaborate with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.
32) Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses.
33) Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.
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Holland / RIASEC Career Code: NA SOC: 11-9121.01