Dept Number/Name: 0-6123-000 / Dept Of Internal Medicine College Division: USF Health-College of Medicine Salary Plan: Administrative Job Code/Title: 4728 / Clinical Research Associate Hiring Salary/Salary Range: $45,000 - $60,000 Position Number: 00052643 "The selected candidate must have current work authorization in the United States. This position is not eligible for VISA Sponsorship." ORGANIZATIONAL SUMMARY: The Department of Internal Medicine is the largest and most complex Department in the Morsani College of Medicine with over 26 Divisions, Programs and Centers/Institutes, total human resources in excess of 1,000, and an annual all-source budget in excess of $143,000,000. The Department's ongoing growth includes the restructure of Cardiovascular Sciences from a separate Department to a Division, support of the microbiome initiative, and the execution of clinical, research and education initiatives focused on COVID-19 and emerging infectious diseases. The mission of the Department is to rank among the elite in the nation in the areas of education, research and patient care. The Department provides education and training for a diverse group of medical students, residents, fellows and health personnel from USF and throughout the world. The Department's research activities are numerous and involve both basic and clinical research activities in all subspecialties of Internal Medicine. Our NIH funding is in excess of $120 million over the past 3 years. Patient care occurs in our affiliated hospitals (including Tampa General Hospital, H Lee Moffitt Cancer Center and Research Institute, James A Haley VA Hospital, Florida Hospital) as well as our state-of-the-art ambulatory health care centers. The Department also provides healthcare support and services via contractual arrangements with many diverse organizations. The US News & World Report recent rankings of our subspecialties include Nephrology at 18, and Gastroenterology at 24 and Primary Care at 67. The Department's faculty represent a group of dedicated physicians that are well-recognized as leaders in all three mission areas. POSITION SUMMARY: The Clinical Research Coordinator (CRC) will coordinate, conduct and evaluate research related activity for clinical research projects as assigned. The primary purpose of this position is to oversee the regulatory component of the clinical trials as well as screening, enrollment and retention of study participants, to coordinate study visits, ensure quality of data collected throughout the research study, and implement procedures and activities of the assigned study protocols, according to all applicable regulations and regulatory compliance, under the direction of the Principal Investigator and the Director of Clinical Research. This position is contract funded. RESPONSIBILITIES: 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. 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 and anthropometric measurements, phlebotomy, ECGs (Electrocardiography), injections and other procedures per protocol. Prepare, process and submit regulatory documents and applications, including consent forms, to the Institutional Review Board(s) and other research review boards and committees as applicable and according to regulatory and institutional requirements. Communicate with PI and site staff, project sponsors and CROs, and review committees to ensure accuracy of regulatory documents and submissions. Track study approvals and expirations to ensure uninterrupted project approvals. Maintain regulatory files for assigned protocols. Assure all reporting requirements are met per regulatory and institutional policies. Assist in the day to day operations of the Department of Internal Medicine 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 CRC liaison with investigators, study staff, USF Health Care and research volunteers as we as research sponsors and Clinical Research Organizations (CROs). Performs 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. SPECIAL SKILLS/TRAINING: Strong working knowledge in Microsoft Office Programs and other software packages. USF Health Information for Applicants This position is subject to a Level 1 criminal background check. Job Opening Number: 37733 Posting Date: 08/26/2024 Posting End Date: 09/09/2024 "The selected candidate must have current work authorization in the United States. This position is not eligible for VISA Sponsorship." 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. USF's Equal Opportunity Affirmative Action Statement. 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. 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