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