Clinical Research Coord III
Job no: 514865
Work type: Staff Full-Time
Location: Main Campus (Gainesville, FL)
Department:29200000 - MD-RADIATION ONCOLOGY
Maintain integrity of clinical trials established with the department.
- Oversees clinical trials within the Department of Radiation Oncology from study start up to completion. Works with Research Administration Manager in study budget development and planning.
- Participate in the review and selection process of new trials to determine feasibility within the department.
- Collaborate with the principal investigator to develop necessary tools to document flow through the clinical trial.
- Serve as clinical and research resource to cooperative group review boards and auditors, in-house review boards and auditors, and site reviewers and auditors.
- Complete clinical trial-required documentation of laboratory and radiology studies, quality of life evaluations, treatment toxicities, and anything else required by the individual trial.
- Works interactively with Protocol Development Manager to draft protocols for PI-iniated clinical trials within the department while ensuring feasibility and identifying potential logistical complications and restructuring protocols to reduce impact to clinic workflow.
Identify potential candidates for entry on current cooperative and in-house clinical trials.
- Educate clinical staff regarding available cooperative and in-house clinical trials and eligibility requirements.
- Meet with patients and family members on a regular basis to complete any study-related activity and to coordinate any communication that is needed between the physician and the patient.
- Coordinate with other departments to meet, consent, and orient patients on multidisciplinary clinical trials and studies.
- Notify clinical staff about potential eligibility for enrollment prior to evaluation and follow-up after evaluation.
- Review consultation and re-evaluation charts prior to patient visit for eligibility.
Work alongside Research Administration Manager to ensure that services to be funded by the grant/clinical trial are clearly noted so pricing may be obtained.
- Assist with any questions that arise during completion of compliance paperwork and during review by the COM, if needed.
- Process all Research Administration and Compliance paperwork for a new study, such as cost of services, billing grids, detailed budgets, Medicare Cost Analyses and Clinical Trial Agreements when the Grants Specialist is unable to do so because of grant deadlines; processing study funding (sponsor's checks for completed visits and study-related activities) to ensure that it is deposited to the correct account; provides copies of order forms for services related to the grant/clinical trial to the Research Administration Manager so invoices may be properly matched and paid in a timely fashion.
- Manage all aspects of receiving and paying research-related invoices and managing all aspects involved in participant reimbursement and compensation.
Obtain all samples from patients in studies, including blood samples and other tissue samples as necessary.
- Confirm samples are appropriately labeled, process samples according to sponsor or study requirements, store samples appropriately until shipment, and collect radiological films and/or CDs and copies as needed.
- Perform venipuncture in order to obtain blood samples.
- Work with Program Assistant to prepare samples for shipment as required by the protocol and ship samples and/or radiological films/CDs in accordance with protocol, local, state and federal requirements.
Manage IRB and WIRB submissions.
- Understand and interpret IRB and WIRB policies and procedures.
- Work with IRB Coordinator to submit regulatory documentation for agency approval on a timely basis to meet ongoing expiration dates.
- Provide IRB Coordinator with study data.
- Attend IRB meetings, including on behalf of PI.
$60,000 - $70,000Minimum Requirements:
Bachelor's degree in an appropriate area of specialization and three years of relevant experience or an equivalent combination of education and experience.Preferred Qualifications:
Certification in Clinical Research Coordination preferred (i.e., ACRP, SOCRA). Phlebotomy certification preferred.Special Instructions to Applicants:
In order to be considered for this position, you must upload your cover letter and resume.
Application must be submitted by 11:55 p.m. (ET) of the posting end date.Health Assessment Required: Yes
Advertised: 15 Oct 2020 Eastern Daylight Time
Applications close: 29 Oct 2020 Eastern Daylight Time