Department: ONC Clinical Research
Status: Full Time
Coordinates, collects and maintains patient data for clinical research studies.
Responsible for the accurate and timely retrieval of data from documented internal and external sources.
Submits timely and accurate data forms and other related materials (slides, pathology, operative reports, and radiology reports) to the relevant cooperative or industry based groups for patients placed on clinical trials Collaborates with Clinical Research
Coordinators to ensure the accuracy of patient data.
Prepares new study patient charts.
Maintains professional relationships with all clinical research participants.
Maintains a registry of study patients at the relevant time points.
Abstracts data from necessary sources to complete pre-study forms, flow sheets, off study forms and other special forms for
Assists in the internal data quality and control process.
Works with coordinators to retrieve follow-up data from patients in the under treatment phase of study.
Reports adverse events according to guidelines and completes required forms.
Schedules appointments and or tests, after consulting with investigators for protocol compliance.
Discusses protocol participation with patients and keeps them informed of procedures and changes to the study.
Assists in the reconsenting process by securing the necessary signatures.
Works with research personnel in the preparation of audits and site visits.
May be required to draw blood from existing peripheral IVs after appropriate Orlando Health training and competency check-off.
Maintains reasonably regular, punctual attendance consistent with Orlando Health policies, the ADA, FMLA and other federal, state and local standards.
Maintains compliance with all Orlando Health policies and procedures.
Other Related Functions
Attends appropriate departmental, corporate and continuing education meetings as required.
Assumes the responsibility for professional growth and development.
Transmits data to sponsoring and regulatory agencies.
High School degree or equivalent.
Experience with Microsoft Windows operating system and Microsoft Office to include: Word, Excel, PowerPoint, and Access.
Orlando Health phlebotomy course within 30 days of hire is required within certain areas.
Two (2) years experience working with data or medical information to include quantitative duties such as data collection, management
and verification. Post-secondary education may offset experience on a 1-to-1 basis
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