Clinical Research Coord I
University of South Florida, Tampa, FL, United States
Job Description
Candidate will perform clinical trial activities as governed by ICH and FDA guidelines. Responsibilities include recruiting and scheduling potential candidates, generating source documents, collecting vital signs, administering surveys, reviewing data accuracy with monitors and sponsors, maintaining equipment, ensuring proper storage and usage of supplies, and contributing to the regulatory binder.
Responsibilities
Clinical Study Coordination and Participant Management: Coordinate a portfolio of clinical research studies under the supervision of the Principal Investigator. Recruit and screen participants; obtain initial and ongoing informed consent. Provide research services and interventions per protocol. Schedule and conduct study visits and follow‑ups within protocol‑defined windows. Administer investigational products and perform protocol‑defined procedures (vital signs, anthropometric measurements, phlebotomy, ECGs, injections, and other assessments). Communicate participant progress and safety updates to investigators.
Clinical Research Center Operations: Assist with daily operations and coordination of CRC activities across multiple studies. Support development, documentation, and dissemination of CRC policies, procedures, and SOPs. Ensure adherence to QA and regulatory compliance. Liaise between CRC and stakeholders including investigators, research staff, USF Health Care providers, volunteers, sponsors, and CROs.
Specimen and Supplies Management: Collect, process, and ship biological samples per study requirements. Maintain biohazardous material shipping certification. Comply with infection control and safety standards. Track and manage investigational product accountability and study supplies. Coordinate with investigational pharmacies and partner institutions as needed. Fulfill registration or certification requirements for research activities at affiliate sites.
Additional Responsibilities: Perform other related duties as assigned to support research goals and institutional mission.
Minimum Qualifications
Bachelor's degree in a related field – OR – equivalent combination of education and experience.
Preferred Qualifications
Human subjects protection training and knowledge of CFR, GCP, and ICH guidelines as applied to clinical trials, including IRB and regulatory processes and HIPAA.
Shipping biohazard materials certification (preferred).
Current clinical research certification (preferred).
Strong working knowledge of Microsoft Office and other software.
Medical and research terminology; pharmacology; phlebotomy experience, ECG training, and training in other clinical procedures.
General knowledge of infection control procedures.
Equal Employment Opportunity
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 for an associate degree; (b) Four years for a bachelor’s degree; (c) Six years for a master’s degree; (d) Seven years for a professional degree; (e) Nine years for a doctoral degree. Related work experience may not substitute for required licensure, certification or registration. Minimum qualifications that require a high school diploma are exempt from SB 1310.
Compliance and Federal Notices
This position may be subject to a Level 1 or Level 2 criminal background check. Applicants have rights under Federal Employment Laws and may request reasonable accommodations.
This job description does not constitute an employment contract.
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Candidate will perform clinical trial activities as governed by ICH and FDA guidelines. Responsibilities include recruiting and scheduling potential candidates, generating source documents, collecting vital signs, administering surveys, reviewing data accuracy with monitors and sponsors, maintaining equipment, ensuring proper storage and usage of supplies, and contributing to the regulatory binder.
Responsibilities
Clinical Study Coordination and Participant Management: Coordinate a portfolio of clinical research studies under the supervision of the Principal Investigator. Recruit and screen participants; obtain initial and ongoing informed consent. Provide research services and interventions per protocol. Schedule and conduct study visits and follow‑ups within protocol‑defined windows. Administer investigational products and perform protocol‑defined procedures (vital signs, anthropometric measurements, phlebotomy, ECGs, injections, and other assessments). Communicate participant progress and safety updates to investigators.
Clinical Research Center Operations: Assist with daily operations and coordination of CRC activities across multiple studies. Support development, documentation, and dissemination of CRC policies, procedures, and SOPs. Ensure adherence to QA and regulatory compliance. Liaise between CRC and stakeholders including investigators, research staff, USF Health Care providers, volunteers, sponsors, and CROs.
Specimen and Supplies Management: Collect, process, and ship biological samples per study requirements. Maintain biohazardous material shipping certification. Comply with infection control and safety standards. Track and manage investigational product accountability and study supplies. Coordinate with investigational pharmacies and partner institutions as needed. Fulfill registration or certification requirements for research activities at affiliate sites.
Additional Responsibilities: Perform other related duties as assigned to support research goals and institutional mission.
Minimum Qualifications
Bachelor's degree in a related field – OR – equivalent combination of education and experience.
Preferred Qualifications
Human subjects protection training and knowledge of CFR, GCP, and ICH guidelines as applied to clinical trials, including IRB and regulatory processes and HIPAA.
Shipping biohazard materials certification (preferred).
Current clinical research certification (preferred).
Strong working knowledge of Microsoft Office and other software.
Medical and research terminology; pharmacology; phlebotomy experience, ECG training, and training in other clinical procedures.
General knowledge of infection control procedures.
Equal Employment Opportunity
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 for an associate degree; (b) Four years for a bachelor’s degree; (c) Six years for a master’s degree; (d) Seven years for a professional degree; (e) Nine years for a doctoral degree. Related work experience may not substitute for required licensure, certification or registration. Minimum qualifications that require a high school diploma are exempt from SB 1310.
Compliance and Federal Notices
This position may be subject to a Level 1 or Level 2 criminal background check. Applicants have rights under Federal Employment Laws and may request reasonable accommodations.
This job description does not constitute an employment contract.
#J-18808-Ljbffr