Director, Clinical Research Regulatory Support

Job Description - Director, Clinical Research Regulatory Support (10028867) Job Description Director, Clinical Research Regulatory Support - ( 10028867 ) 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 l eads 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. As a successful candidate, you will: Oversee the evaluation, revision, and implementation of policies, procedures, and systems to ensure and enhance clinical research regulatory compliance across the COH system. 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. 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. Supervise and manage regulatory support staff, including recruitment, training, performance evaluation, and workload management, while fostering professional growth and development. Serve as a liaison to internal and external auditors, monitors, and cross-functional teams to standardize clinical research regulatory support and implement best practices. Maintain expertise in clinical research regulations through continuing education, professional development, and participation in benchmarking studies, conferences, and institutional initiatives. Qualifications Your qualifications should include: Undergraduate degree with a minimum 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 3 years of relevant experience in a clinical research quality control, quality assurance and / or regulatory compliance environment 5-7 years management experience City of Hope employees pay is based on the following criteria: work experience, qualifications, and work location. City of Hope is an equal opportunity employer. To learn more about our Comprehensive Benefits, please CLICK HERE . Primary Location : United States-California-Duarte Job : Clinical Research Work Force Type : Remote Shift : Days Job Posting : Jan 17, 2025 Minimum Hourly Rate ($) : 76.803500 Maximum Hourly Rate ($) : 128.261800