Senior Regulatory Coordinator

1 month ago

newport beach, United States Russell Tobin Full time

Russell Tobin is seeking a Sr. Clinical Research Regulatory Coordinator for a regional health care delivery network.


Job Title: Sr. Clinical Research Regulatory Coordinator

Location: Newport Beach, CA 92663 (On-Site)

Job Type: Direct Hire

Est. Start Date: January 6, 2025

Hours: 8:30 am – 5pm

Pay Range: $37.38 - $57.46 per hour


Job Summary:

The Sr. Clinical Research Regulatory Coordinator supports clinical research teams (physicians, nurses, etc.) and with minimal direction and considerable use of independent judgment, facilitates the study start-up approval process and maintaining documentation of regulatory compliance throughout the trial's duration for research studies involving human subjects.

The Sr. Regulatory Coordinator ensures all research studies are compliant with regulations and maintains accurate and up-to-date regulatory files.

The Sr. Coordinator is the central resource for regulatory staff conducting clinical research.

Regarding department supporting: Cancer trials account for approx. 70% of trials. Also support GI, Cardiac, Diabetes and Neurology

Essential Duties:

  • Understands current regulatory requirements and ensures a smooth submission process to minimize delays to study initiation.
  • Remains informed of current federal, state, and local regulations regarding clinical research and communicates any changes to study team.
  • Tracks each protocol through the IRB/subcommittee approval process, evaluates for recurrent problems, develops and implements systems to decrease delay in the approval process.
  • Works closely with Investigators and Research Staff on new studies to ensure timely, accurate submissions to the IRB and sponsors.
  • Works with sponsors to ensure all proper regulatory documents are approved and that all documents, access to CRF and databases, monitoring/auditing requirements have been completed prior to the start of a study.
  • Produces and maintains regulatory binders prior to studies starting with all required documents and ensure dedicated electronic study folder is current.
  • Obtains and completes all required documents for new submissions, exemption requests, compassionate uses, amendment applications, continuing review, and closure activities.
  • Completes the External Visitors Checklist to meet badge requirements for access to institution.
  • Reviews informed consents for institutional language and works with legal and sponsors to ensure CTA language is consistent with consent.
  • Works with multiple IRBs and understands submission process and requirements.
  • Provides institutional authorization for new submissions with WIRB.
  • Provides study, enrollment updates, and SAE reports to Clinical Research Oversight Committee.
  • Work with Investigators to renew NCI/CTEP applications.
  • Participates in all investigator meetings, as required.
  • Maintains working knowledge of current protocols and internal SOPs.
  • Assists with the coordination and review of amendments, annual reports, safety reports, and other regulatory submissions required for maintenance of INDs or IDEs.
  • Serves as a team leader within the clinical research regulatory team and trains new regulatory staff, when appropriate.

Education:

  • Bachelor’s Degree


Experience:

  • 5 yrs minimum of regulatory documentation experience in clinical research required
  • 30-50 clinical trials completed at minimum
  • Experience with opening trials, filing applications and submissions for Phase 1 trials
  • FDA and IRB start up experience.
  • Ability to work in fast paced environments.
  • Experience submitting applications and submissions to IRB (Institution Review Board)


Preferred Skills & Experience:

  • Working knowledge of NIH, and OHRP regulatory requirements and ICH GCP guidelines preferred.


Apply Today If you are interested in the position, please email your resume to rob.vanriet@russelltobin.com for immediate consideration.

  • Senior Regulatory Coordinator

    2 weeks ago

    Newport Beach, United States Bahama Consulting Full time

    TITLE: Sr. Regulatory Coordinator LOCATION: Newport Beach, CA (Onsite) SCHEDULE: 8:30 AM - 5 PM PAY: $77K - $119K Annual DOE This is the pay range that BAHAMA Consulting reasonably expects to pay someone for this position. SUMMARY: The Sr. Clinical Research Regulatory Coordinator supports clinical research teams (physicians, nurses, etc.) and with minimal...

  • Senior Regulatory Coordinator

    3 weeks ago

    Newport Beach, United States BAHAMA Consulting Full time

    TITLE: Sr. Regulatory CoordinatorLOCATION: Newport Beach, CA (Onsite) SCHEDULE: 8:30 AM – 5 PMPAY: $77K - $119K Annual DOEThis is the pay range that BAHAMA Consulting reasonably expects to pay someone for this position.SUMMARY: The Sr. Clinical Research Regulatory Coordinator supports clinical research teams (physicians, nurses, etc.) and with minimal...

  • Senior Regulatory Coordinator

    3 weeks ago

    Newport Beach, United States BAHAMA Consulting Full time

    TITLE: Sr. Regulatory CoordinatorLOCATION: Newport Beach, CA (Onsite) SCHEDULE: 8:30 AM – 5 PMPAY: $77K - $119K Annual DOEThis is the pay range that BAHAMA Consulting reasonably expects to pay someone for this position.SUMMARY: The Sr. Clinical Research Regulatory Coordinator supports clinical research teams (physicians, nurses, etc.) and with minimal...

  • Clinical Research Regulatory Coordinator

    3 weeks ago

    Newport Beach, California, United States Russell Tobin Full time

    OverviewRussell Tobin is seeking an experienced Clinical Research Regulatory Coordinator to support the company's regional health care delivery network.About the RoleThis senior role will provide critical support to clinical research teams, ensuring compliance with regulations and facilitating the study start-up approval process. The successful candidate...

  • Senior Regulatory Coordinator

    1 month ago

    Newport Beach, United States Russell Tobin Full time

    Russell Tobin is seeking a Sr. Clinical Research Regulatory Coordinator for a regional health care delivery network.Job Title: Sr. Clinical Research Regulatory CoordinatorLocation: Newport Beach, CA 92663 (On-Site)Job Type: Direct HireEst. Start Date: January 6, 2025Hours: 8:30 am – 5pmPay Range: $37.38 - $57.46 per hourJob Summary:The Sr. Clinical...

  • Senior Regulatory Coordinator

    1 month ago

    Newport Beach, United States Russell Tobin Full time

    Russell Tobin is seeking a Sr. Clinical Research Regulatory Coordinator for a regional health care delivery network.Job Title: Sr. Clinical Research Regulatory CoordinatorLocation: Newport Beach, CA 92663 (On-Site)Job Type: Direct HireEst. Start Date: January 6, 2025Hours: 8:30 am – 5pmPay Range: $37.38 - $57.46 per hourJob Summary:The Sr. Clinical...

  • BAHAMA Consulting | Senior Regulatory Coordinator | newport beach, ca

    3 weeks ago

    newport beach, United States BAHAMA Consulting Full time

    TITLE: Sr. Regulatory CoordinatorLOCATION: Newport Beach, CA (Onsite) SCHEDULE: 8:30 AM – 5 PMPAY: $77K - $119K Annual DOEThis is the pay range that BAHAMA Consulting reasonably expects to pay someone for this position.SUMMARY: The Sr. Clinical Research Regulatory Coordinator supports clinical research teams (physicians, nurses, etc.) and with minimal...

  • BAHAMA Consulting | Senior Regulatory Coordinator | newport beach, ca

    3 weeks ago

    newport beach, United States BAHAMA Consulting Full time

    TITLE: Sr. Regulatory CoordinatorLOCATION: Newport Beach, CA (Onsite) SCHEDULE: 8:30 AM – 5 PMPAY: $77K - $119K Annual DOEThis is the pay range that BAHAMA Consulting reasonably expects to pay someone for this position.SUMMARY: The Sr. Clinical Research Regulatory Coordinator supports clinical research teams (physicians, nurses, etc.) and with minimal...

  • R&D Sr. Regulatory Coordinator

    2 weeks ago

    Newport Beach, United States Integrated Resources Full time

    Job Summary: The Sr. Clinical Research Regulatory Coordinator supports clinical research teams (physicians, nurses, etc.) and with minimal direction and considerable use of independent judgment, facilitates the study start-up approval process and maintaining documentation of regulatory compliance throughout the trial's duration for research studies involving...

  • Regulatory Compliance Specialist

    3 weeks ago

    Newport Beach, California, United States BAHAMA Consulting Corporation Full time

    At BAHAMA Consulting Corporation, we are seeking a skilled Regulatory Compliance Specialist to join our team.About the RoleWe offer a competitive salary of $77K - $119K Annual DOE and a comprehensive benefits package, including Medical, Dental, Vision, HSA, Employee Assistance Program (EAP), STD, LTD, and Life insurance.This is an exciting opportunity for...

  • Regulatory Compliance Specialist

    2 days ago

    Newport Beach, California, United States BAHAMA Consulting Full time

    OverviewBAHAMA Consulting is seeking a highly skilled Regulatory Compliance Specialist to join our clinical research team. In this role, you will be responsible for ensuring compliance with regulatory requirements and maintaining accurate documentation throughout the trial's duration.About the RoleThis is a senior-level position that requires a strong...

  • Regulatory Affairs Coordinator

    2 weeks ago

    Long Beach, California, United States Volt Workforce Solution Full time

    At Volt Workforce Solutions, we're seeking a highly skilled Regulatory Administrator to join our team. This full-time opportunity is based in Long Beach, CA.SalaryThe estimated hourly salary for this role is $36.75, which translates to an annual salary of approximately $76,500.About the RoleThis position involves coordinating with cross-functional teams to...

  • Clinical Research Startup Coordinator: Regulatory Affairs Expert

    2 weeks ago

    Newport Beach, California, United States Russell Tobin Full time

    Job Description:Russell Tobin seeks a detail-oriented clinical research leader to support and participate in all study startup activities for the Center for Clinical Research within a regional health care delivery network.This role will collaborate with key stakeholders to ensure all aspects of the study startup process are met, including activation...

  • Senior Living Activity Coordinator

    7 days ago

    Ormond Beach, Florida, United States Aden Senior Living Full time

    About Aden Senior LivingAt Aden Senior Living, we strive to create an inspired senior living experience for our residents. Our brand-new retirement community is dedicated to serving the Ormond Beach, Florida area with superior care, service, and hospitality.What We OfferCompetitive salary: $45,000 - $60,000 per yearWe cater to our residents by providing a...

  • Senior Regulatory CMC Strategist

    3 weeks ago

    Solana Beach, California, United States LENZ Therapeutics Full time

    Overview:LENZ Therapeutics, a pioneering ophthalmic pharmaceutical company based in San Diego, is seeking a highly skilled Senior Regulatory CMC Strategist to join our team. As a key member of our regulatory affairs department, you will play a vital role in shaping the company's CMC regulatory strategy.The successful candidate will have extensive experience...

  • Senior Regulatory Policy Officer

    4 months ago

    Long Beach, United States Department of Energy, Environment and Climate Action Full time

    The Senior Regulatory Policy Officer role is part of the Animal Welfare Policy team that provides advice to the Minister for Agriculture and senior executive officers about animal welfare policy, regulation and reform. This position will be responsible for leading diverse, complex and challenging projects relating to state policy and regulation development...

  • Senior Transportation Coordinator

    2 weeks ago

    Pompano Beach, Florida, United States Five Star Senior Living Full time

    At Five Star Senior Living, we are seeking a dedicated and experienced Senior Transportation Coordinator to join our team.About the OpportunityWe are actively looking to add a transportation professional who will provide safe, courteous, and on-schedule transportation to our residents and their families. The primary objective for this role is to represent...

  • Senior Litigation Coordinator

    3 weeks ago

    Newport Beach, California, United States AGG Legal Staffing Full time

    About the RoleWe are seeking a highly skilled Senior Litigation Coordinator to join our team at AGG Legal Staffing. This is a fantastic opportunity for an experienced legal professional to take their career to the next level.Job SummaryThe successful candidate will provide support to attorneys, paralegals, and trial fellows in all aspects of litigation. This...

  • Senior Land Development Project Coordinator

    3 weeks ago

    Newport Beach, California, United States Velocity Search Group Full time

    We are seeking a highly skilled Senior Land Development Project Coordinator to join our team at Velocity Search Group. This role will be responsible for coordinating due diligence aspects of commercial land development projects and managing due diligence consultants.Key Responsibilities:Conduct site assessments and utility availability investigationsPrepare...

  • Senior Office Coordinator

    3 weeks ago

    Newport, New Hampshire, United States Leddy Group Full time

    About the RoleWe are seeking an experienced Senior Office Coordinator to join our team and provide high-level support to our President. This is a full-time, direct-hire opportunity that requires at least five years of related experience.Key ResponsibilitiesManage the President's schedule and calendarCoordinate travel arrangements for executives, including...