HCA, Hospital Corporation of America Research & Regulatory Coordinator - Clinical Research (Days) in San Antonio, Texas
General Statement of Duties:
Responsible for maintaining all regulatory affairs for clinical trials as mandated by the FDA regulations.
Essential Job Functions://
Completes and manages the regulatory documents of the research program and timely submits all documents to the Institutional Review Board and the study Sponsors. Independently tracks time sensitive documents for renewals and auditing of protocols keeping within the Federal guidelines. Coordinates correspondence and queries between the Institutional Review Board and the Sponsors.
Creates informed consent documents that are protocol specific under the Methodist Healthcare System Institutional Review Board and the Sponsor requirements.
Tracks all patients enrolled on clinical trials and submits billing forms for each patient as they reach study milestones, maintains tracking tools and coordinates all billing submissions to the finance department. Tracks all study payments and verifies milestones with the clinical trial budget. Maintains and tracks Investigator agreements, Business Associate Agreements, Data Use Agreements are all in place prior to releasing regulatory hold on trials to the clinical staff.
Obtains follow up on off site patient serious adverse events and files these timely to the IRB. Provides trending reports to the Research Coordinator and Principal Investigator on a monthly basis of all serious Adverse Events that are occurring at other sites participating in multicenter clinical trials. Provides written feedback to Sponsors of IRB notifications.
Maintains all regulatory files for each trial assigned by maintaining accurate filing and recording of regulatory information. Coordinates Monitor visits with the research team and the CRA. Conducts the site visit and provides all regulatory information and answers all regulatory queries. Coordinates all pre-study and site selection visits along with the Research Nurse. Maintains a log of all visitors requesting access to the department after visitor identity verification.
Composes correspondence with the sponsors, physicians, committees and prepares reports as requested. Coordinates all research audits by the FDA and independently contracted auditors by collecting all study information and arranging for Investigators, Sponsors and Administrative support. Maintains research committee meetingsand agendas.
Minimum Education and Experience:
High School Graduate; Bachelor’s Degree preferred, certified in research and/or regulatory affairs preferred
Minimum 2 years healthcare or research, preferred
Minimum License and Certificates Required: N/A
Title: Research & Regulatory Coordinator - Clinical Research (Days)
Location: Texas-San Antonio-Methodist Hospital
Requisition ID: 02531-72667