Clinical Research Associate (Finance)
Dept Number/Name: 0-6120-000 / Dept Of Surgery
College Division: USF Health-College of Medicine
Salary Plan: Administrative
Job Code/Title: 4728 / Clinical Research Associate
Hiring Salary/Salary Range: $62,663 - $65,000
Position Number: 00024117
This position is Grant Funded.
ORGANIZATIONAL SUMMARY:
USF Health's mission is to envision and implement the future of health. It is the partnership of the University of South Florida Morsani College of Medicine, the College of Nursing, the College of Public Health, the College of Pharmacy, the School of Biomedical Sciences and the School of Physical Therapy and Rehabilitation Sciences, and the USF Tampa General Physicians group. USF is a global research university ranked 34th in federal research expenditures for public universities. For more information regarding the USF Health, please visit our website at http: //health.usf.edu/index.html
POSITION SUMMARY:
The Clinical Research Associate coordinates, conducts, and evaluates 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, to coordinate study visits, ensure quality of data collected throughout the research study and implement the procedures and activities of the assigned study protocols under the direction of the principal investigator.
RESPONSIBILITIES:
Recruit, screen and provide research related services, interventions and evaluations per protocol for participants enrolled in a 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 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 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.
Prepare and submit documents to the Institutional review board 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.
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 member 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.
Assist in the day to day operations of the clinical research center 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 a liaison with investigators, study staff, USF PG and research volunteers as well as research sponsors and clinical research organizations.
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 in the field of clinical research or a Master's degree in an area of specialization appropriate for the program. Annual certifications may be required to participate in specific studies.
PREFERRED:
Human subjects protection training, knowledge of the code of federal regulations, GCP, ICH 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 certification preferred. Bilingual in English and Spanish is a plus.
SPECIAL SKILLS/TRAINING:
Medical Research Terminology, health care setting processes and procedures, phlebotomy experience. ECG training and/or training in clinical procedures, and general knowledge of infection control. Exposure to research. Human subjects protection training, knowledge of the code of federal regulations, GCP,
ICH Guidelines as applied to clinical trials, IRB and other regulatory processes and procedures including HIPAA.. Shipping biohazard materials certification preferred.
USF Health
Information for Applicants
This position is subject to a Level 1 criminal background check.
Job Opening Number: 38754
Posting Date: 02/13/2025
Posting End Date: 02/22/2025
How To Apply
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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.
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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.
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