| Job Description: |
Responsible for advanced-level coordination and implementation of assigned clinical research studies conducted through UF CARES, including HIV-related and other infectious disease research involving pediatric, adolescent, and adult participants. Independently coordinates assigned treatment, observational, and data/chart-based research studies in accordance with study protocols, institutional policies, Good Clinical Practice (GCP), and
applicable federal and regulatory requirements.
Coordinates research activities throughout the study lifecycle, including participant identification, recruitment and retention; informed consent and assent; study visits and procedures; collection and management of research data; specimen collection and processing; adverse event and protocol deviation reporting; regulatory compliance; and communication with investigators, sponsors, study teams, and other stakeholders.
Maintains knowledge of and compliance with applicable research regulations, institutional policies, IRB requirements, FDA requirements, Good Clinical Practice, sponsor requirements, and protocol-specific procedures. Identifies, documents, and communicates protocol deviations, adverse events, serious adverse events, toxicities, abnormal laboratory findings, and other reportable events according to applicable
requirements and established timelines. Completes laboratory toxicity grading using the DAIDS toxicity table or other protocol-specific grading criteria when applicable.
Performs protocol-required phlebotomy for pediatric and/or adult research participants within demonstrated competency and scope of responsibility. Processes, prepares, labels, stores, tracks, and ships research specimens according to protocol, laboratory, and regulatory requirements. Performs centrifuging and aliquoting and assists with research specimen storage and freezer monitoring/maintenance. Ensures required study laboratory tests and diagnostic procedures are completed, reviewed, and appropriately documented.
Communicates and collaborates with investigators, healthcare providers, research participants and families, research pharmacists, protocol teams, sponsors, monitors, IRB personnel, laboratories, and UF CARES staff regarding study activities and participant needs. Communicates relevant clinical and research information, including signs and symptoms, toxicities, abnormal results, protocol deviations, adverse events, and study requirements, to appropriate members of the research and clinical teams. Serves as a knowledgeable resource regarding assigned protocols and research procedures.
Provides protocol-specific education and in-services to UF CARES staff and other participating personnel as appropriate. Maintains current knowledge of assigned clinical research areas through protocol training, required continuing education, investigator meetings, study activities, and review of relevant research literature.
Serves as a cross-trained resource and backup for other clinical research staff and assists with onboarding and training activities as assigned.
Supports accurate research billing and financial documentation related to assigned studies. Maintains required study visit and billing documentation, completes applicable research referral or billing forms, and works with appropriate research and administrative personnel to ensure study-related services and charges are
appropriately identified and documented.
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| Required Qualifications: |
Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.
Must obtain and maintain required research training and certifications, including CITI, applicable NIH training, and Dangerous Goods/shipping certification, within required institutional or study-specific timeframes.
A valid driver’s license is required due to travel between work locations and study sites.
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| Preferred: |
Bachelor’s Degree in Nursing with current Florida licensure and clinical research experience; master's degree in an appropriate area of specialization; or a bachelor's degree in an appropriate area of specialization with relevant clinical research experience. Two or more years of experience coordinating clinical research studies, preferably involving HIV/AIDS, or infectious diseases. Clinical research certification (e.g., CCRC, CCRP, or equivalent) preferred or ability to obtain certification within two years of hire.
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| Special Instructions to Applicants: |
This is a time-limited position. Time limited positions are based on circumstances, such as funding sources, which control the length of time for which the position is available.
Background Check is Required.
To be considered you must upload your Cover Letter, Resume/CV, and contact information for 3 References.
University of Florida College of Medicine – Jacksonville: Visit this link to watch the video.
Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Work Visa sponsorship is not available for this position
Degrees earned from an education institution outside of the United States are required to be evaluated by a professional credentialing service provider approved by the National Association of Credential Evaluation Services (NACES), which can be found at http://www.naces.org/.
The University of Florida is a public institution and subject to all requirements under the Florida Sunshine and Public Records laws. If an accommodation due to a disability is needed to apply for this position, please call (352) 392-2HRS or the Florida Relay System at (800) 955-8771 (TDD). Hiring is contingent upon eligibility to work in the US. Searches are conducted in accordance with Florida's Sunshine Law.
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