Clinical Research Assistant

• A Clinical Research Assistant assists with the conduct of clinical research-related activities, including but
• not limited to patient recruitment and enrollment, collecting patient information, completing case report
• forms, and data entry. This position typically reports to the Principal Investigator, Clinical Research
• Manager, or Clinical Research Coordinator. This job is a pre-entry position for the Clinical Research
• Coordinator career path. Within its specialized support duties, it receives moderate supervision. Handles
• basic issues and problems and refers more complex issues to higher-level staff. The assignments are
• semi-routine in nature, including collecting and entering data and working with the study coordinator to
• ensure their accuracy and integrity, in strict adherence to study protocols. Requires knowledge and
• experience with basic computer skills and web-based applications.

• Assists with the evaluation of potential research participants with the study team and Principal

Investigator.

• Assists with screening, enrollment, and retainment of study participants at the site.
• Schedules participant site visits and maintains records.
• Assists Clinical Research Coordinators and site study team in recording data on each study

participant for each visit according to research protocol.

• Assists with the implementation of procedures and activities of assigned study protocols.
• Participates in coordinating, preparing, and conducting site monitoring visits, audits, and

inspections.

• Collects vitals and assists study coordinator with patient visits at the site.
• Collects study specimens according to the protocol which may include phlebotomy, processing,

and preparation for shipping.

• Performs data entry for clinical trials.
• Assists with site quality assurance and tracks regulatory submissions.
• Performs other duties as assigned.
• High School Diploma or equivalent required.

Knowledge, Skills & Abilities

• Knowledge of planning and scheduling techniques.
• Knowledge of clinical operations and procedures.
• Knowledge of medical terminology.
• Skill in the use of personal computers and related software applications.
• Ability to gather data, compile information, and prepare reports.
• Ability to work as part of a team.
• Senate Bill 1310- The Florida Senate (https://www.flsenate.gov/Session/Bill/2023/1310) is

conditional upon meeting all employment eligibility requirements in the U.S.

• SB 1310: Substitution of Work Experience for Postsecondary Education Requirements
• 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.