Director of Clinical Research

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

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

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

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

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

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

Communicate with laboratories or investigators regarding laboratory findings.

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

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

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

Organize space for study equipment and supplies.

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

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

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

Solicit industry-sponsored trials through contacts and professional organizations.

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

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

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

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

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

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

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

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

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

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

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

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

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

Order drugs or devices necessary for study completion.