At Cedars-Sinai, we're committed to being a leader in clinical research. We're currently conducting more than 900 active research projects and our projects are funded by the National Institutes of Health. We're able to reach these high levels of research excellence because of the support and skill of our research staff.
The Samuel Oschin Comprehensive Cancer Institute (SOCCI) welcomes you explore our Clinical Research Regulatory Manager opportunity. As the Clinical Research Regulatory Manager, you will work in collaboration with the Director of the Clinical Research Office (CRO) of the Samuel Oschin Comprehensive Cancer Institute (SOCCI). Your input and expertise will make a difference to drive and produce high standards within the regulatory program. You will assure all regulatory program development within the CRO is compliant with federal, state, and local regulations and is in alignment with the National Cancer Institute's (NCI) Cancer Center Support Grant guidelines. You will build and oversee a team of highly skilled research staff and will be accountable for the delivery of efficient, compliant regulatory services.
You will work with the CRO Director and SOCCI Executive Director to develop, lead, and grow a robust, comprehensive regulatory unit supporting investigators in the development, activation, conduct, and reporting of cancer-relevant clinical trials.
You will provide expertise content and training for faculty and staff in areas of regulatory affairs, sponsor-investigator support services, and requirements related to the NCI's Protocol Review and Monitoring System.
You will ensure all federal, state, and local regulations, Good Clinical Practices, ICH, ClinicalTrials.gov, and Institutional Review Board requirements are met.
You will maintain a centralized office composed of knowledgeable, professional staff supporting clinical research services related to: 1)Protocol Review & Monitoring System, 2)Data and Safety Monitoring Committee, 3)Regulatory Affairs, 4)Protocol Development Core (investigator-initiated trials and multi-center support)
You will be responsible for planning, organizing and oversight of the regulatory research operations. You will participates in the preparation of annual reports, presentations, and NCI data reporting requirements. Prepare activity reports for SOCCI leadership to inform business decision. Analyze, identify, and recommend strategic organizational improvements.
You will work collaboratively with institutional leaders, peers, and external parties to develop and implement solutions to improve efficiencies and increase compliance.
Provide supervision, guidance, and mentorship to unit leaders and staff. In addition, foster professional growth development of staff and will be accountable for staff performance and compliance.
Collaborate with SOCCI program leaders, Disease Research Group leaders, and SOCCI faculty to foster the development of investigator-initiated clinical trials and improve efficiencies in clinical research management.
Finally you will represent Cedars-Sinai Medical Center and/or SOCCI at local, state, and national meetings.
Since its beginning in 1902, Cedars-Sinai has evolved to meet the healthcare needs of one of the most diverse regions in the nation, continually setting new standards in quality and innovation in patient care, research, teaching and community service. Today, Cedars-Sinai is widely known for its national leadership in transforming healthcare for the benefit of patients.Cedars-Sinai is one of the largest nonprofit academic medical centers in the U.S. with 886 licensed beds, 2,100 physicians, 2,800 nurses and thousands of other healthcare professionals and staff. Clinical programs range from primary care for preventing, diagnosing and treating common conditions to specialized treatments for rare, complex and advanced illnesses. In addition, Cedars-Sinai serves the community through its Medical Network, which includes the highly rated Cedars-Sinai Medical Group and Cedars-Sinai Health Associates. Cedars-Sinai has consistently been named one of America’s Best Hospitals by U.S. News & World Report, has received the National Research Corporation’s Consumer Choice Award 18 years in a row for providing the highest quality medical care in Los Angeles, and has the longest running Magnet desig...nation for nursing excellence in California. Cedars-Sinai is a leader in the clinical care and research of heart disease, cancer and brain disorders, among other areas. Pioneering research achievements include using cardiac stem cells to repair damaged hearts, developing minimally invasive surgical techniques and discovering new types of drugs to target cancer more precisely. Cedars-Sinai also impacts the future of healthcare through education programs that encompass everything from highly competitive medical residency and fellowship programs to a biomedical science and translational medicine PhD program, advanced training for nurses and educational opportunities for allied health professionals. Most notably, Cedars-Sinai demonstrates a longstanding commitment to strengthening the Los Angeles community through wide-ranging programs that improve the health of its most vulnerable residents.