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Collaborate with the Principal Investigator, Patient, Sponsor, and the IRB. MUST be registered with BBS as a AMFT/ACSW/APCC. Masters Degree from accredited school of Psychology, Social Work, Marriage and Family Therapy, or LPCC and registered with the Board of Behavioral Science (BBSE) or Board of Psychology.
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Knowledge of medical/oncology process and terminology; experience and knowledge of IRB policy and procedure; background in science/medicine preferably in hematology/oncology. In addition to supervising clinical research coordinators, the CRC Supervisors / Protocol Project Manager will serve as the main point of contact between the Principal Investigator (PI) and Sponsor during study activation and maintenance.
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They may assist with Institutional Review Board (IRB) filings, sponsor and investigator filings and research related presentations. This position is in the Cardiac Electrophysiology Department which treats and studies the electrical component of the heart by way of ablation procedures and/or cardiac device implants (internal cardioverter defibrillator, pacemaker.
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The CRA I will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting. Manage adverse event and deviation/violation/exception documentation for all enrolled patients and report to the sponsor and IRB as required.
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Determine whether all adverse events (AEs) are appropriately reported within the time periods required by GCP, the protocol, the Ethic Committees (IRB/IEC), Sponsor and the applicable regulatory requirement(s.
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Oversees pre-award administration of grants and contracts activities, which includes: proposal submission and coordination; proposal budget and justification preparation; sponsor and university proposal form completion; coordination of IRB and ACUC protocols; sub-recipient coordination; coordination of facilities and administrative costs, space, and co-investigator agreements; and Just In Time (JIT) protocol.
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The CRA/CRC I will be the liaison between the clinical team, sponsor, and Institutional Review Board (IRB) to ensure appropriate communication and reporting. The Clinical Research Associate/Clinical Research Coordinator I (CRA/CRC I) works under general supervision to enroll eligible patients to clinical research protocols and manage all aspects of data collection and submission for multiple cancer studies.
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Ensures initial and ongoing consent process is performed and documented in compliance with FDA, Good Clinical Practice (GCP), institutional sponsor, IRB, and other applicable regulations, guidance's, and policies.
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Using established procedures, perform assessments independently and in collaboration with the physician investigator to ensure that the objectives of an established oncology research protocol are met and in compliance with IRB and sponsor guidelines.
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The incumbent is also responsible for maintaining communication with all elements of a multi-level research network, including attending Disease Oriented Teams (DOTs) meetings, interacting with sponsoring agencies including National Cancer Institute, and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors.
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In addition, familiarity with a variety of other aspects of sponsored research administration will be required, including cost accounting standards (CAS), Institutional Review Board (IRB) for human subjects in research, Institutional Animal Care and Use Committee (IACUC) for animal subjects in research, financial conflict of interest (FCOI), export control, and other specific UF policies.
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Knowledge of ICH GCP, IRB/IEC, and local regulatory authority drug research & development regulations. Supports and monitors clinical trials to ensure sponsor and investigator obligations are met and in compliance with the currently approved protocol/amendment(s); applicable study procedures; applicable federal and local regulatory requirements; GCP; and company policy and procedures.
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Clinical Research Coordinator B (Cardiovascular Institute) Clinical Research Coordinator B. Choose from a wide variety of investment options through TIAA and Vanguard. The research coordinator will assist in the management of multiple clinical trials and will be responsible for study coordination for industry studies, investigator-initiated studies, and multi-center research studies.
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Coordinate behavioral health research activities including developing surveys, managing study records, attending study meetings, submitting Institutional Review Board (IRB) and sponsor reports.
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Identifies adverse events and protocol deviations or violations, reports findings to PI, sponsor and IRB under general direction of clinical research manager. Works closely with Regulatory Manager to maintain accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, and study related communication.
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