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.