Clinical Research Coordinators

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

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

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

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

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

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.

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

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

Prepare study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.

Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts, such as protocol revisions.

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

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

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

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

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

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.

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

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

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

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

Communicate with laboratories or investigators regarding laboratory findings.

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

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

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

Order drugs or devices necessary for study completion.

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

Solicit industry-sponsored trials through contacts and professional organizations.

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

Organize space for study equipment and supplies.

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