Maintain required records of study activity including case report forms, drug dispensation records, or regulatory forms.

• Maintain regulatory or compliance documentation.

Oversee subject enrollment to ensure that informed consent is properly obtained and documented.

• Monitor activities of individuals to ensure safety or compliance with rules.

Schedule subjects for appointments, procedures, or inpatient stays as required by study protocols.

• Schedule activities or facility use.

Monitor study activities to ensure compliance with protocols and with all relevant local, federal, and state regulatory and institutional polices.

• Monitor organizational compliance with regulations.

Perform specific protocol procedures such as interviewing subjects, taking vital signs, and performing electrocardiograms.

• Interview employees, customers, or others to collect information.

Dispense medical devices or drugs, and calculate dosages and provide instructions as necessary.

Record adverse event and side effect data and confer with investigators regarding the reporting of events to oversight agencies.

• Maintain regulatory or compliance documentation.
• Communicate with government agencies.

Assess eligibility of potential subjects through methods such as screening interviews, reviews of medical records, and discussions with physicians and nurses.

• Interview employees, customers, or others to collect information.

Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.

• Conduct financial or regulatory audits.

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.

• Prepare operational progress or status reports.

Track enrollment status of subjects and document dropout information such as dropout causes and subject contact efforts.

• Maintain operational records.

Maintain contact with sponsors to schedule and coordinate site visits or to answer questions about issues such as incomplete data.

• Coordinate operational activities with external stakeholders.

Inform patients or caregivers about study aspects and outcomes to be expected.

• Communicate organizational information to customers or other stakeholders.

Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks.

• Analyze risks to minimize losses or damages.

Direct the requisition, collection, labeling, storage, or shipment of specimens.

• Manage operations, research, or logistics projects.

Code, evaluate, or interpret collected study data.

Register protocol patients with appropriate statistical centers as required.

Participate in preparation and management of research budgets and monetary disbursements.

• Manage organizational or project budgets.

Interpret protocols and advise treating physicians on appropriate dosage modifications or treatment calculations based on patient characteristics.

• Advise customers on technical or procedural issues.

Arrange for research study sites and determine staff or equipment availability.

• Schedule activities or facility use.

Participate in the development of study protocols including guidelines for administration or data collection procedures.

• Develop organizational methods or procedures.

Instruct research staff in scientific and procedural aspects of studies including standards of care, informed consent procedures, or documentation procedures.

• Conduct employee training programs.

Communicate with laboratories or investigators regarding laboratory findings.

• Confer with organizational members to accomplish work activities.
• Coordinate with external parties to exchange information.

Contact outside health care providers and communicate with subjects to obtain follow-up information.

• Interview employees, customers, or others to collect information.
• Coordinate with external parties to exchange information.

Review scientific literature, participate in continuing education activities, or attend conferences and seminars to maintain current knowledge of clinical studies affairs and issues.

• Maintain knowledge of current developments in area of expertise.

Contact industry representatives to ensure equipment and software specifications necessary for successful study completion.

• Coordinate operational activities with external stakeholders.

Order drugs or devices necessary for study completion.

• Purchase materials, equipment, or other resources.

Confer with health care professionals to determine the best recruitment practices for studies.

• Confer with organizational members to accomplish work activities.

Solicit industry-sponsored trials through contacts and professional organizations.

• Promote products, services, or programs.

Collaborate with investigators to prepare presentations or reports of clinical study procedures, results, and conclusions.

• Coordinate operational activities with external stakeholders.

Organize space for study equipment and supplies.

• Plan facility layouts or designs.

Develop advertising and other informational materials to be used in subject recruitment.

• Develop promotional materials.