Director, Clinical Research Regulatory Support

City of Hope; California, Duarte (MO, CA); Remote; USD 80,000 - 120,000; Full time

Job summary

Join a transformative organization dedicated to fighting cancer and other life-threatening illnesses. This remote role as Director of Clinical Research Regulatory Support Services involves leading a team to ensure regulatory compliance across the system. You will collaborate with researchers, manage submissions, and provide training on compliance. With a commitment to professional growth, this position offers a chance to make a significant impact in a mission-driven environment. If you have a passion for clinical research and regulatory affairs, this is an exciting opportunity to contribute to meaningful change.

Qualifications

• 5+ years of experience in clinical research quality control or regulatory compliance.
• Management experience is essential for overseeing regulatory support staff.

Responsibilities

• Oversee regulatory compliance for clinical research across the COH system.
• Manage regulatory submissions and ensure audit readiness.

Skills

Regulatory Compliance

Clinical Research

Quality Assurance

Team Management

Education

Undergraduate Degree

MS Degree in Scientific Discipline

Job description

Director, Clinical Research Regulatory Support Services (Remote)

Join the transformative team at City of Hope, where we're changing lives and making a real difference in the fight against cancer, diabetes, and other life-threatening illnesses. City of Hope's growing national system includes its Los Angeles campus, a network of clinical care locations across Southern California, a new cancer center in Orange County, California, and treatment facilities in Atlanta, Chicago, and Phoenix. Our dedicated and compassionate employees are driven by a common mission: to deliver the cures of tomorrow to the people who need them today.

Reporting to the Vice President of Duarte Clinical Research Operations, this remote role leads the oversight of regulatory support services for clinical research across the COH system. Manage a team of regulatory coordinators to ensure compliance with federal regulations, state statutes, and institutional policies. Serve as a regulatory compliance liaison, providing guidance to principal investigators and staff, reviewing submissions, and implementing strategies to improve regulatory compliance and address deficiencies.

Responsibilities

1. Oversee the evaluation, revision, and implementation of policies, procedures, and systems to ensure and enhance clinical research regulatory compliance across the COH system.
2. Lead the planning, accuracy, and timely execution of regulatory submissions to committees such as IRB, CPRMC, DSMB, and IBC, while ensuring audit/inspection readiness of regulatory binders and platforms.
3. Collaborate with COH researchers on protocol design, consent creation, and regulatory requirements, and provide training on federal, state, and institutional compliance via seminars and workshops.
4. Supervise and manage regulatory support staff, including recruitment, training, performance evaluation, and workload management, while fostering professional growth and development.
5. Serve as a liaison to internal and external auditors, monitors, and cross-functional teams to standardize clinical research regulatory support and implement best practices.
6. Maintain expertise in clinical research regulations through continuing education, professional development, and participation in benchmarking studies, conferences, and institutional initiatives.

Qualifications

• Undergraduate degree with a minimum of 5 years of relevant experience in a clinical research quality control, quality assurance, and/or regulatory compliance environment, or
• MS degree in a scientific discipline with a minimum of 3 years of relevant experience in a clinical research quality control, quality assurance, and/or regulatory compliance environment.
• 5-7 years of management experience.

City of Hope employees' pay is based on work experience, qualifications, and work location.

City of Hope is an equal opportunity employer. To learn more about our commitment to diversity, equity, and inclusion, please click here.

To learn more about our comprehensive benefits, please CLICK HERE.