University Of Florida Gainesville , FL 32601
Clinical Research Coord I
As a Study Coordinator I in our Solid Tumor Unit (STO) unit you will collaborate with other coordinators and research staff, physicians, nurses, and other key personnel in the clinic and at the Cancer Center to ensure compliance with protocol requirements and satisfactory care for enrolled patients. In this role specifically, you will also collaborate with the STO Manager and CRO Leadership to track and report upon clinical trial performance metrics for the ETG pod. Most importantly in the execution of your duties, you will advocate for and promote efficient, effective, and compassionate care for patients enrolled on research protocols. In your new role you will be responsible for the following:
Coordination of Protocol Subjects
A significant responsibility of our Study Coordinators is the coordination of relevant care and protocol required testing for subjects enrolled on their assigned trials. You will be assigned a portfolio of human clinical trials and will be responsible for managing and coordinating protocol required care for enrolled patients. This will include facilitating and explaining the informed consent process, educating patients and their families on the medical aspects of the trial, as well as overseeing the general and trial related care of their patients. You will communicate with patients on a regularly scheduled basis and assesses progress, evaluate problems and determine appropriate action or physician consultation as needed. Additionally, you will communicate with family members, physicians, other health care agencies involved with the patients' care and follow-up status.
This will also include following each subject's clinical course during inpatient hospitalizations and at clinic visits, confirming that all protocol-specific tests and procedures are completed within study timelines. Prior to scheduled patient visits, you will also prepare pre-printed study orders and study information sheets and secure appropriate approvals as required. You will also be responsible for entering and tracking all subject status changes in the Clinical Trials Management System (CTMS). In order to ensure all research partners are up to date on your patients you will also attend UFHCC and Hematology/Oncology research meetings and Investigator meetings, preparing and/or presenting requested information on your trials.
Chart Review & Data Interpretation
Part of your job as a coordinator is to interpret and collect medical and clinical data from potential and existing subjects for their assigned trials. This includes data from a variety of sources which you will transcribe onto paper case report forms and/or into OnCore/Epic. Using data taken from clinic visits, prospective patient interviews, and medical records, you will identify possible protocol candidates and confirm patient eligibility for protocol participation. You will also use this data to evaluate clinical toxicities using the grading criteria specified in your protocols. Most importantly, it is essential that you provide accurate and complete data to study sponsors according to protocol timelines and protect subject privacy in compliance with relevant privacy laws.
Metric Management & Research Support
You will be responsible for tracking metrics to the screening process and working with the STO Manager and the Assistant Director of Study Coordination & Data Management. This will include verifying the accuracy of screening information in CTMS and for the identification of possible protocol candidates. In confirming patient eligibility, you will attend patient care conferences/clinics, interview prospective participants, and review medical records.
You will be responsible for all compliance with all internal and external regulatory and institutional requirements related to the trials assigned to you. This will include attending all relevant trainings and meetings including Tumor Boards, monthly lunch and learns, etc. as required and providing in-service education related to assigned protocols to ensure compliance. More broadly, you will ensure your compliance with the QA/QC as well as the IRB and regulatory activities of the Cancer Center.
For QA and QC efforts, you will collaborate with monitors and sponsors' data management units to resolve compliance issues and discrepancies. Using your experience and understanding of oncology and its treatment, you will act as a resource for Study Coordinator Is in the administration of toxicity assessments in compliance with protocol guidelines and in the identification of concerns and protocol violations.
For IRB and Regulatory affairs you will be responsible for collaborating with internal and external IRB staff to ensure all regulatory documents are appropriately submitted and to endure SAEs and deviations are properly reported.
You will also participate in fiscal audits to ensure compliance with established billing procedures and ensure your compliance with established UF, UFHCC, and UF Health fiscal policies and procedures.
You will also be ultimately responsible for coordinating sample collection, analysis, and shipping for your trials. This will include collaborating with laboratory staff and BMT CRAs to ensure that laboratory work is completed in accordance with your studies' protocols. This will include coordinating research sample collection with clinical collection personnel and confirming that samples are appropriately labeled following collection. You will be responsible for adhering to pertinent safety and quality policies and procedures for the handling, processing, disposal, and shipping of biological specimens and ensuring that research samples are processed according to protocol and/or sponsor requirements.
It is the responsibility of the Study Coordinator to verify that research samples are stored appropriately until shipment and then to prepare samples for shipment as required by the protocol and ship samples in accordance with sponsor, protocol, local, state and federal requirements.
$38,000 $47,000 annual salary; commensurate with education and experience.
Associate's degree or an allied health professional degree in an appropriate area and one year of relevant experience; or an equivalent combination of education and experience.
As an ideal candidate you will have:
Bachelor's Degree in Nursing, Heath Care, and/or Basic Sciences and three to four years of relevant experience and/or training in research and/or oncology preferred;
Experience with databases and/or patient data;
Proficiency with Microsoft Office suite, particularly Excel, Word;
Demonstrated ability and/or aptitude with reviewing and reporting upon moderate to complex data trends;
Ability to successfully work independently, interact professionally, and utilize effective writing and organizational skills
Proficient time management skills and ability to successfully manage multiple priorities;
Licensure as a registered professional nurse in accordance with Chapter 464 Florida Statutes or eligibility to practice nursing in accordance with Section 210 Florida Administrative Code;
Professional clinical research and/or oncology certification (through SOCRA, ACRP, etc. or as an OCN) are required at the earliest of 12 months from hire or eligibility.
Special Instructions to Applicants:
Applicants must upload a copy of the following documents to be considered for this position:
Cover Letter or Letter of Interest
Curriculum Vitae or Resume
List of 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.
Health Assessment Required:Yes