Clinical Research Assoc.

Nature of Work: This work involves many aspects of a traditional clinical research coordinator—arranging and facilitating timely study visits, ensuring quality of data collected throughout the research study, and implementing procedures and activities of the assigned study protocols, according to all applicable regulations and regulatory compliance, under the direction of the Director of Clinical Research & Principal Investigator. This position is time limited. Recruit, screen, and provide research-related services, interventions, and evaluations per protocol for participants enrolled in OB/GYN clinical research studies under the direction of the Principal Investigator (PI). Provide initial and ongoing informed consent with participants and families. Schedule study visits and procedures and follow-up study visits per protocol visit windows. Administer investigational product per protocol. Perform study-related procedures such as collection of vital signs, phlebotomy, and other procedures per protocol as delegated by the PI and in accordance with training and experience. Communicate participant status to Investigator and research team as well as other entities as required. Strive to enhance subject retention in assigned protocols. Assure all reporting requirements are met per regulatory and institutional policies. Compile and maintain research progress notes and source documents and record data for each study participant in accordance with the research protocol. Monitor participants’ unexpected and adverse events, laboratory, radiology, and other procedure test results, and report to Investigator, sponsor, and IRB (Institutional Review Board) as appropriate. Collect and report study data on paper Case Report Forms or in electronic data capture systems per protocol, including query resolution. Develop source document templates as needed per protocol. Monitor clinical study activity to ensure compliance with the protocol, site SOPs (Standard Operating Procedures), and all applicable regulations, including HIPAA (Health Insurance Portability and Accountability Act) regulations. Prepare and submit documents to the Institutional Review Board(s) and other research review boards and committees as applicable and according to regulatory and institutional requirements. Compile and maintain regulatory files for assigned protocols. Coordinate, prepare for, and participate in monitoring visits, audits, and inspections. Collect, process, and ship research specimens. Achieve and maintain certification in bio-hazardous materials shipping. Ensure that infection control and safety procedures are implemented and maintained. Maintain investigational article accountability records and manage clinical supplies as required for assigned protocols. Interface with Investigational Pharmacy and Affiliate Institutions for assigned studies as applicable. Fulfill required certification or registration processes when assigned to research projects where study visit activity occurs at Affiliate Institutions. Educate patients, families, and staff in regard to clinical research activity. Complete and maintain necessary training to stay abreast of current regulatory guidelines. Participate in the planning and execution of education and training activities, specific to assigned studies and to general clinical research educational activities. Serve as a resource for both internal and external customers and members of the community in regard to clinical research processes, developments, and trends in the field, as well as referrals to specific OB/GYN clinical research studies as applicable. Performs 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. 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.