Clinical Research Associate

The primary purpose of this position is to oversee the regulatory component of the clinical trials as well as screening, enrollment and retention of study participants, to coordinate study visits, ensure quality of data collected throughout the research study, and implement procedures and activities of the assigned study protocols, according to all applicable regulations and regulatory compliance, under the direction of the Principal Investigator and the Director of Clinical Research.

This position requires a level II Background check.

This position is Grant Funded.

30% Clinical Research Coordination

• Coordinates site visits and collect /manage patient and lab data for sponsored and investigator-initiated studies. 
• Monitor clinical studies and communicate status to PI and other personnel involved in the study. 
• Assist in patient pre-screening and organization of recruitment. 
• Review protocol enrollment forms and confirm patient eligibility before patient registration, including obtaining all necessary informed consent forms. 
• Participate in follow-up and assists in the care of patient complications. May assist with clerical and patient care as needed; assist with patient visit check-in (obtaining vitals); oversee medications and treatments.
• Responsible for coordinating, scheduling, and ensuring proper utilization of laboratory and other research facilities.

25% Research Data and Specimen Management

• Collect, organize, and analyze research samples/data from all trials and studies in the division. 
• Process samples for both investigators initiated and clinical research trials. 
• Primary processing lab technician for patient samples regarding the biorepository specimen. New studies are implemented to determine the most effective methods for locating, identifying, screening, and accepting subjects into new studies according to protocols.
•  Assure safety and infection control measures are implemented. 
• Ensure data quality control. 
• Oversee data collection from remote study sites

25% Regulatory Compliance and Study Administration

• Prepare initial applications for IRB submission, modification requests, and continuing reviews. 
• Prepare and maintain regulatory and compliance documents. 
• Interpret and apply rules and regulations about clinical research to ensure compliance (i.e., Code of Federal Regulations). 
• Interpret and apply requirements and standards set forth by the National Institutes of Health and the FDA. 
• Recommend changes in procedures to locate, accept, and track clients. 
• Actively participate in meetings about protocols to ensure consistent interpretation and adherence to protocols at all stages of study. 
• Evaluate protocol study forms and reviews records for completeness, accuracy, and compliance in preparation for external audits. 

10% Clinical Research Operations

• Oversee and organize investigational research visits on a case-by-case basis.
• Ensure patient visit occurs, along with proper sample collection and shipment to collaborating institution. 
• Handle the sample collection for inpatient study subjects. 
• Work with the primary care team to ensure safe and proper collection. 

5% Research Financial and Contract Management

• Coordinate establishing collaborative research contracts and agreements for the division and individual studies (MTAs, CTAs, DTAs, CRAs, etc.) 
• Organize clinical research stipend payment and maintains payment database.
• Direct project supply ordering for studies and laboratory facilities

5% Clinical Support and Other Duties

• Enter orders, medication refills, create encounters, document telephone notes, and upload documentation.
• Other duties as assigned

This position requires a 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.

Degree Equivalency Clause: Four years of direct experience for a bachelor’s degree.
• 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