This position is the lead study coordinator for the Department of Surgery Clinical Research Administration group. Responsible for managing and overseeing all aspects of service related research, industry sponsored, physician initiated, retrospective and prospective, and humanitarian device exemption studies. The individual answers directly to the Clinical Research Manager and interacts regularly with Principal Investigators for Transplant Surgery, Pediatric Surgery, Plastic Surgery, and General Surgery. The individual is required to establish and maintain professional relationships with the Office of Clinical Research, the Institutional Review Board and the Research Billing Office. Reviews patient records for medical results. Corresponds with referring physicians, patients, patient families, nursing staff, pharmacists, patient coordinators and other staff regarding research protocols. Isolates blood and tissue components as directed. Collects and ships specimens as directed. Implements patient care activities as assigned according to guidelines and under the supervisor of the Principle Investigator. Coordinates patient reimbursement for study participation when appropriate.
Duties include but are not limited to:
- Develop and analyze clinical research activities for participants and makes changes in processes and procedures as necessary.
- Oversee patient enrollment and provide clinical care to participants enrolled in clinical trials under the direction of the PI as it relates to study procedures; including collecting blood at various time points in clinical trials.
- Assess and report patient reactions to clinical staff and PI.
- Manages tests, procedures, and equipment per protocol requirements.
- Schedule procedures, especially those involving multi-disciplinary efforts.
- Expected to participate in daily patient rounds.
- Provide education to patients and families as related to the study and reinforce patient and family education as related to their study responsibilities; includes being available 24/7 to study patients, family, physicians, or RNs for questions or concerns related to study.
- Educate and mentor clinical staff, Clinical Research Administration group, and others involved in the clinical trials on protocols and enrollment of qualified subjects. Develop educational materials for patients, referring physicians, clinical staff, and Clinical Research Administration group to promote patient accrual on clinical trials. Coordinates with nursing staff regarding patient care per protocol.
- Assure strict compliance of study protocols including those related to surgical procedures, imaging, labs, and clinic visits.
- Point of contact for sponsor representatives visiting the site.
- Must be knowledgeable in institution IRB and Western IRB policies, procedures and standards of conduct.
- Assist the PI in providing research compliance and oversight related to all studies.
- Oversees the IRB process, including the creation, coordination and/or development of research protocols, informed consents and introductory questionnaires for IRB submission.
- Serve as mentor to Research Regulatory Specialist and other group members.
- Submit protocol registration and results information to ClinicalTrials.gov, a web-based data entry system that provides public access to a directory of federally and privately supported clinical trials that test the effects of drugs, biologics, devices, and procedures on medical diseases and conditions per institution and government requirements.
- Coordinate and develop research project budgets, calculating personnel and facilities costs with the Manager of Clinical Research and PI.
- Create fiscal research accounts by working closely with facility lab, Investigational Drug Pharmacy, Radiology, Cardiovascular Lab and clinics.
- Forecast expenditures for the entire project budget period to ensure that the project is neither overspent nor inappropriately underspent.
- Assist Manager of Clinical Research with negotiating budget and fees with the Sponsors.
- Create and submit project invoices to sponsoring agencies for patient related charges and per patient enrollment fees.
- Must be knowledgeable in policies, procedures, and standards-of-conduct that promote adherence to applicable laws, as well as to the requirements of the facility, institution, federal, state, and private funding agencies.
- Provide an annual report to CMS outlining all project related Medicare billing accounts.
- Ensure all research related charges are settled prior to study closure.
- Review all payments to ensure that they were made by the appropriate source, and that all services billed to research participants and their third-party payors were not paid with study funds.
- Responsible for subject enrollment and patient follow-up for all approved projects.
- Maintains/collects data for study patients accurately and completely.
- Maintains multiple electronic databases based on individual projects.
- Submits monthly patient screening and prescreening information to multiple sources.
- Responsible for completing sponsor requested data clarification and query forms in a timely manner.
- Other duties as assigned
- Background in nursing in surgery or other clinical field or a certified phlebotomist is preferred.
- Knowledge regarding IRB procedures, forms, and approval process.
- Ability to communicate information verbally and in writing.
- Ability to establish and maintain effective working relationships with others.
- Ability to type letters, memorandums, and other standard business documents in correct format.
- Ability to operate general office equipment.
- Ability to communicate with patients, their parents and family.
- Knowledge of topical wound care, wound assessments, and dressing application.
|Special Instructions to Applicants:
To be considered for the position, you must upload a cover letter, resume and a list of at least three professional references.
The University of Florida is an equal Opportunity Employer dedicated to building a broadly diverse and inclusive faculty and staff.
This is a time-limited position.
Application must be submitted by 11:55 p.m. (ET) of the posting end date.
This requisition has been reposted. Previous applicants are still under consideration and need not apply.