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Regulatory Coordinator II (Remote Option)

Company: Cedars-Sinai
Location: Beverly Hills
Posted on: May 26, 2023

Job Description:

Highly qualified candidates, residing in California, Arizona, Nevada, Oregon, Texas, Colorado, Minnesota, Florida, and Georgia, will be considered for remote work. Those that reside outside of these states will not be considered - Do you have a passion for the highest clinical quality and patient happiness? Would you like to use your expertise with an organization known nationally for excellence in cancer treatment, research and education? We would be happy to hear from you! Please consider the following exciting opportunity with one of the most outstanding and dynamic places to work in the medical field as your next career move. The Regulatory Coordinator II prepares and submits protocols and supporting documents to regulatory bodies such as PRMC, IRB, and IACUC. -This role submits continuations, amendments, responds to questions, generates reports, and maintains research files and documentation involving the regulatory requirements for the study/clinical trial. -Other duties include, representing the medical center when meeting with pharmaceutical companies, attending weekly team meetings, and working with other staff to insure all regulatory documents and requirements are met and up-to-date. -May plan and coordinate strategies for improving efficiency, action plans to improve quality, and training and education of personnel. -Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB). ESSENTIAL JOB DUTIES AND RESPONSIBILITIES:

  • Prepares and submits protocols and supporting documents to regulatory bodies such as PRMC, IRB, and IACUC.
  • Submits continuations and amendments as necessary to maintain compliance with regulatory requirements and institutional policies.
  • Responds to all questions from the IRB or IACUC related to the regulatory aspects of the study.
  • Completes forms and generates all reports necessary to comply with regulatory requirements and institutional policies.
  • Establishes and maintains research files and documentation pertaining to regulatory requirements for clinical trials.
  • Meets with monitors from pharmaceutical companies and represents the medical center during these meetings.
  • Works closely with the clinical trial coordinator, research staff, and investigators to assure that all regulatory documents for the research studies are up-to-date.
  • Attends weekly research team meetings and updates staff and investigators on the status of regulatory submission and amendments.
  • May provide training and education of other personnel.
  • May participate in centralized activities of the department or institution.
  • May plan and coordinate strategies to improve existing standard operating procedures related to regulatory affairs.
  • May identify quality and performance improvement opportunities and collaborate with staff in the development of action plans to improve quality.
  • May be required to develop clinical trial budgets.
  • Ensures compliance with all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board.
  • Maintains research practices using Good Clinical Practice (GCP) guidelines.
  • Maintains strict patient confidentiality according to HIPAA regulations and applicable law.
  • Participates in required training and education programs. DEPARTMENT AND/OR UNIT SPECIFIC - ESSENTIAL JOB RESPONSIBILITIES:
    • Independently responsible for regulatory management for high performing/productive and/or emerging disease research groups (DRG) with moderate to complex research designs and high volumes (i.e. accrual, timelines etc.)
    • Adheres to critical deadlines and target timelines.
    • May actively participate in program building within disease research group
    • May lead assigned project improvement, optimization or enhancements with direct oversight and guidance provided by management team
    • May participate in or lead other department initiatives as assigned
    • May provide training, mentorship and/or support to junior staff to ensure adequate regulatory compliance and critically evaluate incoming requests or issues
    • Serves as liaison for Industry sponsors, clinical coordination/nursing and investigators.
    • Responsible for ensuring investigator regulatory files and documents are accurate and complete.
    • Assists in the preparation of and participates in clinical trial educational reviews, monitoring visits (internal or external) and compliance audits.
    • Provides guidance, under supervision of Manager or designee, to physicians and principal investigators, IBC, CPRMC, PRMC, DSMC, and IRB in the interpretation of applicable regulations and guidelines, to include but not limited to GCP, GLP, ICH, FDA, and NIH OBA guidelines.
    • Maintains professional growth and development through seminars, workshops, and professional affiliations to keep abreast of latest trends in the field of expertise. Educational Requirements:
      • BA/BS degree
      • ACRP/SoCRA/RAPs (or equivalent) certification preferred. Experience:
        • Three (3) years minimum of directly related experience, or equivalent combination of education and experience. Working Title: Regulatory Coordinator II (Remote Option)Department: SOCCI Clinical Research OfficeBusiness Entity: Cedars-Sinai Medical CenterJob Category: Compliance/QualityJob Specialty: Research CompliancePosition Type: Full-timeShift Length: 8 hour shiftShift Type: DayBase Pay:$64,800.00 - $110,000.00

Keywords: Cedars-Sinai, Beverly Hills , Regulatory Coordinator II (Remote Option), Other , Beverly Hills, California

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