Clinical Research Regulatory Coordinator, Senior: Hoag Clinical Research

Primary Duties And Responsibilities

• 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. 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 ensures 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.

Qualifications

Education and Experience

• Associate Degree or equivalent education and experience required. Bachelor Degree preferred.
• More than one (1) year of regulatory documentation experience in clinical research required
• Working knowledge of FDA, NIH, and OHRP regulatory requirements and ICH GCP guidelines preferred

About Us

Hoag Memorial Hospital Presbyterian is a nonprofit regional health care delivery network in Orange County, California, consisting of three acute-care hospitals with sixteen urgent care centers, eleven health centers and a network of more than1,800 physicians, 100 allied health members, 8,000 employees, and 2,000 volunteers. More than 30,000 inpatients and 550,000 outpatients choose Hoag each year.

For over 70 years, Hoag has delivered a level of personalized care that is unsurpassed among Orange County's health care providers. Since 1952, Hoag has served the local communities and continues its mission to provide the highest quality health care services through the core strategies of quality and service, people, physician partnerships, strategic growth, financial stewardship, community benefit and philanthropy.

Hoag offers a comprehensive blend of health care services including six institutes providing specialized care in the areas of cancer, heart and vascular, neurosciences, women's health, orthopedics, and digestive health through our institutes.

Hoag was the highest ranked hospital in Orange County in the 2024-2025 U.S. News &World Report, the only Orange County hospital ranked in the top 10 for California. The organization was ranked the #5 hospital in the Los Angeles Metro Area and the #10 hospital in California.

To learn more about Hoag's awards and accreditations, visit: .

Hoag is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Hoag is committed to the principle of equal employment opportunity for all employees and providing employees with a work environment free of discrimination and harassment. Hoag hires a diverse group of people in a manner that allows them to reach their full potential in the pursuit of organizational objectives.