Clinical Research Associate

About the role

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 a small amount of 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. This position is Grant-Funded.

Responsibilities

• 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 data bases based 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.

Qualifications

• Bachelor's degree in a field directly related to the program responsibilities and one year of professional experience; or Master's degree in an area of specialization appropriate for the program.
• Senate Bill 1310: A public employer may include a postsecondary degree as a baseline requirement only as an alternative to the number of years of direct experience required, not to exceed: (a) Two years of direct experience for an associate degree; (b) Four years of direct experience for a bachelor's degree; (c) Six years of direct experience for a master's degree; (d) Seven years of direct experience for a professional degree; or (e) Nine years of direct experience for a doctoral degree. Related work experience may not substitute for any required licensure, certification, or registration required for the position of employment as established by the public employer and indicated in the advertised description of the position of employment. Minimum Qualifications that require a high school diploma are exempt from SB 1310.