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