USF College of Nursing · 20 hours ago
Clinical Research Coordinator I
Tampa, FL, United States
Full-time
Onsite
Entry Level
4+ years expThe USF College of Nursing is seeking a Clinical Research Coordinator I to manage a portfolio of clinical research studies. The role involves coordinating participant management, ensuring compliance with regulatory standards, and assisting with the daily operations of the Clinical Research Center.
Higher Education
Responsibilities
Coordinate a portfolio of clinical research studies under the supervision of the Principal Investigator (PI). Recruit and screen participants; obtain initial and ongoing informed consent from participants and families. Provide research-related services and interventions per study protocol. Schedule and conduct study visits and follow-ups within protocol-defined visit windows. Administer investigational products and perform protocol-defined procedures, such as: Vital signs and anthropometric measurements, Phlebotom, Electrocardiograms (ECGs), Injections and other clinical assessments as delegated and based on training/experience, Communicate participant progress and safety updates to Investigators
Assist with the daily operations and coordination of CRC activities across multiple research studies and users. Support the development, documentation, and dissemination of CRC policies, procedures, and standard operating procedures (SOPs). Ensure adherence to quality assurance and regulatory compliance standards. Serve as a liaison between CRC and internal/external stakeholders including investigators, research staff, USF Health Care providers, volunteers, sponsors, and Contract Research Organizations (CROs)
Collect, process, and ship biological samples per study requirements. Maintain biohazardous material shipping certification and comply with all infection control and safety standards. Track and manage investigational product accountability and study supplies. Coordinate with Investigational Pharmacies and partner institutions when applicable. Fulfill registration or certification requirements for research activities conducted at affiliate sites
Perform other related duties as assigned to support research goals and institutional mission
Qualification
Required
Bachelor's degree
Four years of direct experience for a bachelor's degree
Compliance with employment eligibility requirements in the U.S
Adherence to quality assurance and regulatory compliance standards
Preferred
Human subjects protections training
Knowledge of the Code of Federal Regulations
GCP (Global Good Clinical Practice)
ICH (International Council for Harmonization) Guidelines as applied to clinical trials
IRB and other regulatory processes and procedures including HIPAA
Shipping biohazard materials certification
Current certification in clinical research
Strong working knowledge in Microsoft Office programs and other software packages
Medical and research terminology, processes and procedures
Phlebotomy experience
ECG training and training in other clinical procedures
General knowledge of infection control procedures
Benefits
Medical, dental and life insurance plans
Retirement plan options
Employee and dependent tuition programs
Generous leave
Hundreds of employee perks and discounts
Company
USF College of Nursing
The USF College of Nursing began in 1973 by enrolling its charter class into the Bachelor’s Program.
51-200 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase