Duties & Responsibilities:

• In collaboration with VA researchers and staff physicians, identify and recruit potential subjects who meet eligibility criteria as outlined in the study protocol.

• 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.

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

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

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

• Code, evaluate, or interpret collected study data.

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

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

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

• Coordinate various clinical research studies per study protocol whilst meeting protocol guidelines and applicable IRB and FDA Regulations simultaneously

• Manage patients visits and facilitate proper completion of study requirements per study sponsor standards

• Coordinate with research physicians, raters, and other study staff for timely completion of all study activities and ensure all resources are available for completion of study visits

• Process and ship laboratory specimens for analysis.

• Other duties as assigned.