Clinical Research Associate (Finance)
Dept Number/Name: 0-6122-000 / Obstetrics/Gynecology
College Division: USFHealth-College of Medicine
Salary Plan: Administrative
Job Code/Title: 4728 / Clinical Research Associate
Hiring Salary/Salary Range: $45,000 - $60,000
Position Number: 00044153
ORGANIZATIONAL SUMMARY:
The Department of Obstetrics and Gynecology is committed to delivering the highest quality and most compassionate patient care, training highly competent and caring clinicians, and generating the most innovative research. To these ends, we provide up to date clinical services to care for women at all stages of their lives. Our faculty represent a group of dedication physicians and research scientists who are well recognized as leaders in all three mission, clinical care, research and education. We also place at the top of our priority list the educational activities within the College of Medicine; including education of fellows, residents and medical students. In ObGyn, we strive for a culture which recognizes and rewards an academic entrepreneurial spirit, productivity, teamwork, integrity and kindness.
POSITION SUMMARY:
The Clinical Research Associate will coordinate, conduct and evaluate research related activity for clinical research projects as assigned. The primary purpose of this position is to oversee the screening, enrollment and retention of study participants in the IMPACC clinical trial. This involves enrolling and collecting both biologic specimens along with matched clinical demographics and complex clinical outcome metadata at pre-specified timepoints. Biologic specimens will be used to prepare multiple complex bioanalytes on site, which will be batched and shared with multiple analysis centers throughout the U.S. This work involves many aspects of a traditional clinical research coordinator - arranging and facilitating timed 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 Director of Clinical Research & Principal Investigator.
RESPONSIBILITIES:
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 (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, injections 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.
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 (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 but also many of the responsibilities of a research laboratory technician in terms of the preparation of bioanalytes. Specific skills required will include the preparation of serum, CyTOF-suitable blood and sputum specimens and in the isolation and recovery of PBMC fractions from the buffy coat of blood. Lastly, this individual will be involved in the processing, management, preparation and shipment of specimens to achieve comprehensive project objectives.
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.
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.
Working mostly at TGH and supporting the biorepository
Other duties as assigned.
POSITION QUALIFICATIONS:
MINIMUM:
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.
PREFERRED:
Human subjects protections training, knowledge of the Code of Federal Regulations, GCP (Global Good Clinical Practice), and ICH (International Council for Harmonization) Guidelines as applied to clinical trials, IRB and other regulatory processes and procedures including HIPAA. Medical and research terminology, processes and procedures, phlebotomy experience, ECG training and training in other clinical procedures, and general knowledge of infection control procedures.
Shipping biohazard materials (IATA) certification preferred.
Current certification in clinical research is preferred.
Bilingual in English and Spanish a plus.
Strong working knowledge in Microsoft Office programs and other software packages.
SPECIAL SKILLS/TRAINING:
Human Subjects Training, IATA, HIPAA, experience with bioanalyte preparation, human clinical trial coordinator experience
USF Health
Information for Applicants
This position is subject to a Level 1 criminal background check.
Job Opening Number: 38765
Posting Date: 02/13/2025
Posting End Date: 02/27/2025
How To Apply
Click on the Apply Now button. When applying to an opening you will have the opportunity to upload a cover letter and resume.
Apply online by completing the required information and attaching your cover letter and resume. Please include your experience as it relates to the qualifications stated above. YOUR COVER LETTER AND RESUME, PLUS ANY OTHER REQUESTED MATERIAL, MUST BE IN ONE ATTACHMENT. Only online applications are accepted for this position.
Click here for additional tutorial information.
To request an accommodation with the application or interview process, please contact Central Human Resources by telephone: 813-974-2970 or email HR-ADA-Request@usf.edu .
Equal Employment Opportunity
USF is an equal opportunity, equal access academic institution that embraces diversity in the workplace.The University of South Florida does not discriminate on the basis of sex and prohibits sexual harassment. Any person may report sex discrimination, including sexual harassment (whether or not the person reporting is the person alleged to be the victim of conduct that could constitute sex discrimination or sexual harassment), in person, by mail, by telephone, or by electronic mail, using the contact information listed for the Title IX Coordinator. Reports may be made at any time either online or directly to the University's Title IX Coordinator.
Federal Rights
Applicants have rights under Federal Employment Laws: Family and Medical Leave Act (FMLA) , Equal Employment Opportunity (EEO) and Employee Polygraph Protection Act (EPPA) .
Work Location
Campus map and location overview:
USF - Health
USF - Tampa Campus
About USF
The University of South Florida is a high-impact global research university dedicated to student success. Over the past 10 years, no other public university in the country has risen faster in U.S. News and World Report's national university rankings than USF. Serving more than 50,000 students on campuses in Tampa, St. Petersburg and Sarasota-Manatee, USF is designated as a Preeminent State Research University by the Florida Board of Governors, placing it in the most elite category among the state's 12 public universities. USF is a member of the American Athletic Conference.
Working at USF
With more than 16,000 employees at USF, the University of South Florida is one of the largest employers in the Tampa Bay region. At USF you will find opportunities to excel in a rich academic environment that fosters the development and advancement of our employees. We believe in creating a talented, engaged and driven workforce through on-going development and career opportunities. We also offer a first class benefit package that includes medical, dental and life insurance plans, retirement plan options, tuition program and generous leave programs and more.
To learn more about working at USF please visit: Work Here. Learn Here. Grow Here .
Connect with us:
