Clinical Research Associate

This position collects and manages patient and/or laboratory data for a clinical research project. The position oversees the screening and enrollment of clients, gathers and analyzes data on health care programs, develops databases , analyzes data, ensures quality control, and compiles reports for regulatory compliance.

Nature of Work: This position typically reports to the principal investigator of a clinical research study. The position may perform evaluation duties in preparation for the project. The position then performs project activities such as overseeing the screening and enrollment of potential clients for a health services protocol, developing materials to communicate the project to potential clients and their families, coordinating site visits and appropriate collection of data, ensuring quality control in the data, and compiling regulatory reports. This position may require specific computer expertise and may require maintaining information on a web site. Work at this level meets the FLSA criteria for a professional exemption since the primary duties are work that requires advanced knowledge, which is predominantly intellectual in character and requires the consistent exercise of discretion and judgment. Clinical Research Administrators typically oversee temporary staff or Research Support Specialists. They differ from the non-exempt staff by developing techniques and overseeing clinical data gathering, establishing quality control standards, composing educational materials, and acting as liaison with regulatory agencies. Clinical Research Administrators are not overall project directors. They do not set overall project direction nor do they have responsibility for final interpretation of project results. This position may perform some general administrative duties such as monitoring budgets, and drafting administrative forms and reports. Work is distinguished from an Administrative and Business Analyst through its primary emphasis on overseeing client recruiting and testing, and analyzing clinical data rather than general administrative work.

Oversees medical or health recruiting and screening protocols, collecting data for research studies. May oversee remote screening locations. Monitors laboratory tests and referrals.

Recruits and trains assistants who gather data.

Monitors compliance of study procedures with Federal, state and university regulations. Ensures that documents such as eligibility forms and informed consent are appropriately gathered and maintained, HIPAA regulations are followed, and that infection control, and safety procedures are implemented.

Prepares and maintains regulatory and compliance documents such as IRB applications. Interprets rules and regulations pertaining clinical research to ensure compliance in research projects.

Recommends changes in procedures in order to locate, accept, and track clients.

Collects and analyzes data from clinical trials or other medical screening. Creates databases for client information or medical records, and analyzes data.

Collaborates with social workers and professional agencies to provide services related to health conditions.

Composes and disseminates information on studies to clients and the general public.

Acts as performance consultant to subcontractors or health departments to produce model quality programs

Drafts program reports for publication and/or public dissemination.

Provides education to clients and clients families regarding clinical protocols.