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Clinical Research Lead & Regulatory Affairs Associate

Company: Arizona Heart Rhythm Center
Location: Phoenix
Posted on: November 26, 2022

Job Description:

Our State of Art Cardiology Research Facility is located in Central Phoenix and seeking a Clinical Research Regulatory Affairs Associate Regulatory Affairs Associate provides direction for the daily operational coordination for all regulatory aspects of sponsored and investigator-initiated research projects. Associate leads the coordination of regulatory activities with sponsors, clinical research organizations (CROs), clinical research staff, and institutional review boards (IRBs). Serves as the professional resource for regulatory information, handles the submission of electronic regulatory documents, and maintains electronic site documents.CORE FUNCTIONS1. Prepare and submit research applications and perform regulatory study start-up activities. Edit and correct informed consents, assist Principal Investigators (PIs) with protocol and study-related document development, facilitate ongoing continuation reports to the IRB, study amendment reporting, and complete other submissions to respective IRBs as required.2. Maintain all electronic regulatory documents, including protocols, investigator brochures, consents, and recruiting materials. Facilitate completion of continuing reviews and amendments per sponsor, participating institutions, Good Clinical Practice (GCP), FDA, and other applicable federal, state, and local regulatory agency regulations, policies, and procedures.3. Act as site's regulatory point-person to provide information to the PI, Research Manager, and study staff regarding IRB submissions and approvals of study-related documents. Maintain protocol status updates for pending and active projects.4. Interact with sponsors and CROs, providing requested regulatory documents throughout the life of a study. Participate in site initiation visits, sponsor monitoring, audits, and FDA inspections to review electronic regulatory binders.5. Coordinate regulatory activities with the needs of the research staff or the IRB to ensure timely submission of all regulatory documents and requests of sponsors.6. Maintain up-to-date knowledge of federal, state, and local research regulatory requirements. Serve as designated regulatory point-person for audits performed by regulatory agencies. Engage in core customer service measures exhibit professional standards to ensure human subjects' protection in clinical research.7. Perform other administrative dutiesMINIMUM QUALIFICATIONS Requires a bachelor's degree in business, healthcare administration, or science-related field or at least two years of substantial and ongoing professional experience working in the regulatory research environment.Job Type: Full-timePay: $45,000.00 - $80,000.00 per yearBenefits: 401(k) Dental insurance Health insurance Paid time off Vision insuranceSchedule: 8 hour shiftAbility to commute/relocate: Phoenix, AZ 85013: Reliably commute or planning to relocate before starting work (Required)Education: Bachelor's (Preferred)Experience: FDA regulations: 1 year (Preferred)Work Location: One location

Keywords: Arizona Heart Rhythm Center, Phoenix , Clinical Research Lead & Regulatory Affairs Associate, Healthcare , Phoenix, Arizona

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