Job no: 535574
Work type: Staff Full-Time
Location: Main Campus (Gainesville, FL)
Categories: Office/Administrative/Fiscal Support, Health Care Administration/Support
Department: 29050600 - MD-HEMATOLOGY/ONCOLOGY
Classification Title:
Clinical Research Coordinator II
Classification Minimum Requirements:
Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.
Job Description:
The Department of Medicine, Division of Hematology and Oncology is seeking a full time Clinical Research Coordinator II. This position will be a member of a multi-disciplinary team which will manage hematologic and oncologic diseases studies. This position will also develop and maintain infrastructure for all clinical trials and grant related studies. The clinical research coordinator will include, but not limited to data management related to the treatment, clinical follow-up for research patients, working in OnCore, Sponsor sites, tracking revenue and expense for all studies and additional locations as needed.
The incumbent will be responsible for all assigned research studies within the Division of Hematology and Oncology and will be expected to work with minimal supervision.
Essential Functions;
• Collects data from medical records, including medical history, diagnosis, pathology, laboratory, radiology, specialty test results, progress notes, reported side effects or adverse reactions and dose modifications.
• Maintains patient protocol records for data accuracy, source documentation and assurance of compliance with protocol guidelines.
• Submits required data to the appropriate sponsor in a timely manner.
• Collaborates with monitors and/or with sponsors’ data management units to resolve case report form discrepancies. Collaborates with internal and external IRB staff to ensure all regulatory documents are appropriately submitted.
• Registers participants in the OnCore System
• Identifies possible protocol candidates and confirms patient eligibility for protocol participation by attending patient care conferences/clinics, interviewing prospective participants and reviewing medical records.
• Provides patient teaching related to the informed consent document and confirms that informed consent documents are appropriately executed.
• Registers or randomizes patients with appropriate sponsor. Educates patients and families on the medical aspects of protocols, testing procedures, visit schedules and side effects of chemotherapy and/or other therapeutic drugs. Identifies potential economic problems.
• Follows study patient hospitalizations, clinic/office visits, treatments and scheduled activities. Orders protocol tests and communicates these test results to patients and their families. Communicates with patients on a regularly scheduled basis and assesses progress, evaluates problems and determines appropriate action or physician consultation as needed. Communicates and interacts with family members, physicians, nurses and other health care agencies involved with the patients care and follow-up status.
• Fiscal billing for studies and revenue/expense tracking.
• Creates study budget grids, resolves study subject billing issues.
• Works with OnCore to get studies started and works with Grants team on Grant studies.
• Acts as resource for clinical staff in the administration and toxicity assessment of protocol regimens. Provides in-service education necessary to facilitate protocol compliance. Directs concerns of protocol violations to Primary Investigator or appropriate physician.
• Acts as liaison for institution with clinical trial sponsors, NCI and data managers involved with protocols. Answers data queries, monitors for data delinquencies, and replies to special requests as necessary. Participates in research audits as required. Attends internal meetings when requested.
• Obtains, processes, stores and ships clinical samples according to sponsor requirements.
• Attends Investigator meetings as needed.
• Oversees volunteer(s).
• Perform other duties as assigned.
• Management and Facilitation of the Hemophilia Treatment Center (HTC), American Thrombosis and Hemophilia Network (ATHN), and other disease related registries centering around the enrollment, registration, treatment and follow-up of Pediatric and Adult Benign Hemophilia subjects. This is in support of a multi-disciplinary team that serves a broad patient base in both pediatrics and adults, at both UF Health inpatient and outpatient facilities, across multiple service lines, as well as supporting Adult Benign Hematology program at the North Florida/South Georgia Veterans Administration Hospital.Expected Salary:
$46,000 - $60,000 Annually
Required Qualifications:
Bachelor's degree in an appropriate area and two years of relevant experience; or an equivalent combination of education and experience.
Preferred:
Experience working in OnCore, EPIC and REDCap.
Experience in Excel, Word and databases required.
Required to work independently, interact professionally and possess effective writing and organizational skills.
Special Instructions to Applicants:
In order to be considered, you must upload your resume.
Application must be submitted by 11:55 p.m. (ET) of the posting end date.
Health Assessment Required: Yes
Salary : $46,000 - $60,000
