Department: Office of Clinical Research / 0-6001-005 College/Division: College of Medicine Hiring Salary/Salary Range: $60,000-$76,000/year
Organizational Summary: The mission of the Office of Clinical Research (OCR) is to provide faculty with resources, information and expertise in clinical research to advance the science of healthcare. The OCR facilitates the process of conducting clinical research, from inception through completion, with the ultimate goal of delivering state of the art healthcare services to the community in the Greater Tampa Bay area and beyond. Our office manages non-federally sponsored clinical research studies for faculty in the Morsani College of Medicine and is comprised of three functional areas; clinical services, business operations, and fiscal operations.
Position Summary: The Nurse/Researcher will coordinate, conduct and evaluate clinical research related activities as assigned as well as develop and grow the USF Health Clinical Research Center. The primary purpose of this position is to oversee the screening, enrollment and retention of study participants, to coordinate study visits, ensure quality of data collected throughout the research study, and implement the procedures and activities of the assigned study protocols, according to all applicable regulations and regulatory compliance, under the direction of the Principal Investigator. As a Registered Nurse, the Nurse Researcher utilizes education and expertise to oversee patient-related activities of the studies.
DUTIES: 40%: Recruit, screen and provide research related services, interventions and evaluations per protocol for participants enrolled in clinical research studies under the direction of the Principal Investigator. 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 and anthropometric measurements, phlebotomy, ECGs, injections, infusions 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 protocol. Assure all reporting requirements are met per regulatory and institutional policies and procedures. Track and report participant study visit activity and procedures for assigned protocols.
30%: Under the Assistant Director, develop and build the USF Clinical Research Center (CRC) including hiring and supervising additional personnel as the unit research activity increases. Assist with supervision of the day to day operations of the Clinical Research Center (CRC) including the coordination of clinical research study activities amongst all users of this shared resource. Assist with the development and dissemination of policies, procedures and site SOPs for the CRC. Ensure quality assurance of research activities conducted in the CRC. Serve as an OCR/CRC liaison with investigators, study staff, USFPG and research volunteers as well as research sponsors and Clinical Research Organizations (CROs). Track and report on CRC utilization.
15%: Compile and maintain research progress notes and source documents and record data for each study participant in accordance with the research protocol. Monitor participant's unexpected and adverse events, laboratory, radiology, and other procedure test results and report to Investigator, sponsor and IRB 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 and all applicable regulations, including HIPAA regulations.
5%: 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.
5%: 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 clinical research studies as applicable.
5%: Collect, process and ship research specimens. Achieve and maintain certification in biohazardous 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
QUALIFICATIONS (Education & Experience): Minimum Qualifications: This position requires licensure as a registered nurse in accordance with Chapter 464, Florida Statutes, or eligible to practice nursing in accordance with Chapter 64 B9, Florida Administrative Code. Bachelor's degree in Nursing with two years of nursing research or directly related experience; OR an Associate's degree in Nursing with four years of same experience. A Master's degree in Nursing is Preferred. Annual certifications may be required to participate in specific studies.
Preferred Qualifications: This position requires a Bachelor's degree in Nursing with two years of clinical nursing experience and two years of clinical research experience preferred; OR an Associate's degree in Nursing with four years of same experience.
Preferred Experience: Two or more years of professional experience in a clinical research setting or similar experience with human research participants. Experience in a variety of therapeutic areas is preferred. Experience in phlebotomy and IV infusions strongly preferred. Supervisory experience is preferred.
Additional Knowledge Requirements: Human subjects' protections training, knowledge of the Code of Federal Regulations, GCP and ICH Guidelines as applied to clinical trials, IRB and other regulatory processes and procedures including HIPAA. Medical and research terminology, processes and procedures. Knowledge of infection control procedures. BLA and/or ALS certification preferred. Shipping biohazardous materials certification preferred. Current certification in clinical research is preferred. Bilingual in English and Spanish a plus.
This position is subject to a criminal background check.