Clinical Research Coordinator III

• Manage the day-to-day activities of the assigned research studies, including problem-solving, communication, and protocol management with the PI.
• Supervise OPS and volunteers involved in assigned studies.
• Support clinical conduct of research and perform these duties as needed.
• Review and develop a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, and privacy protections.
• Communicate study requirements to all individuals involved in the study. Provide appropriate training and tools for study team members. Document date of training and signatures of study personnel trained on the study-specific training log.
• Conduct in-services as needed with hospital staff.
• Collect documents needed to initiate the study for submission to the sponsor (e.g., FDA Forms 1572, CVs, etc.).
• Develop and implement recruitment strategies in accordance with IRB requirements and approvals in collaboration with the PI and the study team.
• Conduct or participate in the informed consent process, including interactions with the IRB, discussion with research participants, and answering any questions related to the protocol. Obtain appropriate signatures and dates on forms in appropriate places. Assure that amended consent forms are appropriately implemented and signed.
• Screen subjects for eligibility using protocol-specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
• Register each participant in the Oncore.
• Coordinate participant tests and procedures.
• Administers medications, isolates blood and/or tissue components as directed by protocols as appropriate.
• Examine and assess patients.
• Monitor physical status of the patients, participate in rounds, and select patients for clinical studies.
• Collect data as required by the protocol. Assure timely completion of Case Report Forms.
• Maintain study timelines.
• Maintain adequate inventory of study supplies, including Investigational Drug/Device Accountability.
• Complete study documentation and maintains study files in accordance with sponsor requirements and University policies and procedures, including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms etc.
• Retain all study records in accordance with sponsor requirements and University policies and procedures.
• Maintain effective and ongoing communication with the sponsor, research participants, and PI during the course of the study.
• Assist PI in preparation and submission of any modifications to the scientific protocol in accordance with Federal regulations and University and sponsoring agency policies and procedures.
• Build and work with data within REDCap.

Regulatory and IRB: Responsible for regulatory operations and associated administrative tasks related to assigned research studies:

• Follow the Office of Clinical Research’s (OCR) required initial submission process.
• Complete and send out required OCR documents, including but not limited to cost of service forms (COS), billing grids, device/drug tables, etc.
• Prepare initial submissions, revisions, and continuing reviews to the IRB for submission.
• Prepare serious adverse events and deviation logs after review with the PI for IRB submission.
• Attend all IRB meetings when assigned protocols are scheduled.
• Review and comprehend the protocol and collaborate with the PI and research manager to prepare IRB and any other regulatory submission documents.
• Prepare other study materials as requested by the PI. These study materials include, but are not limited to, the informed consent document, Form FDA 1572, financial disclosures, and PI licenses as needed.
• Ensure proper organization of study files, including but not limited to, regulatory binders, study-specific source documentation, and other materials by the research coordinator assigned to the investigation.
• Maintain templates and examples of essential documents frequently used in the preparation of a protocol, i.e., informed consent, telephone script.
• Perform quality assurance, ensuring proper maintenance of regulatory binder, protected health information, and study documents.
• Coordinate internal audits as deemed appropriate.
• Sponsor Contract/Budget and fiscal management.
• Build finance tracker off finalized contract/budget.
• Track study activities on the finance tracker and in Oncore, as applicable.
• Review the budget and contract with the research manager for assigned research studies to help with the request for hospital costs of services (COS).
• Assist with negotiating the budget.
• Help with invoicing as outlined in the contract/budget, as applicable.
• Process human subject payments (HSP) for study participants as applicable.
• Preparation and/or Review of Scientific Proposal
• Assist PI and research staff in reviewing protocols for feasibility.
• Assist PI and research staff with providing data for study or grant submissions. 

• Assist PI and research staff with data for study or grant interim reports.
• Assist PI and research staff with registration of study in clinicaltrials.gov and maintain current information on the site.

$65,000 - $76,000; commensurate with experience

Must be a Registered Nurse (RN). Bachelor's degree in an appropriate area and three years of relevant experience; or an equivalent combination of education and experience.

• Experience with UF institutional processes regarding grants/sponsored projects (IRB, ONCORE, OCR Compliance). Advanced knowledge of research protocols and principles of clinical research.
• Bachelor's or Master's with two years of clinical experience.
• Registered nurse, experience phlebotomist, or interest in obtaining certification in phlebotomy. Prior Perioperative Patient Care is valuable. Knowledge of nursing principles, practices, and techniques.
• Obtain and maintain appropriate clinical research certification (ACRP or SOCRA).
• Proven ability to work in various computer programs (Microsoft, Adobe, etc.)
• Proven ability to understand, interpret, and apply applicable rules, regulations, policies, and procedures in addition to collecting, collating, analyzing, and evaluating data from clinical research studies.

In order to be considered, you must upload your cover letter and resume.

This is a time-limited position.

Application must be submitted by 11:55 p.m. (ET) of the posting end date.