Clinical Trials Regulatory Specialist 2

The Stanford Center for Clinical Research (SCCR) is a growing academic research organization within the Stanford Department of Medicine. Our mission is to conduct and promote high-impact, innovative clinical research to improve human health. SCCR seeks a mission-driven Clinical Trials Regulatory Specialist 2. You will work with a high-performing team of clinical operations staff and clinical experts. Responsibilities will include ensuring compliance with GCPs and SOPs, and collaborating with clinical operations, finance, quality, education, and business development managers. You will work closely with company sponsors, clinical research organizations, Stanford Cellular Immune Tolerance (CIT) Research Program and their study teams, Stanford IRB and other external IRBs, the FDA and other regulatory authorities, and any other entities who contribute to clinical research at our institution. The CIT Research Program vision is the development and clinical translation of cutting-edge curative cell therapies to restore immune tolerance in autoimmune and transplant patients. At SCCR, we strive to find team members who are passionate about their work, flexible, fun, and want to deliver results. We place a high priority on equipping our staff to perform their job efficiently, helping them acquire new skills and grow within the organization. We encourage our team to have a healthy balance between work commitments and life outside of work and provide support to achieve this balance. If you are looking to make a large impact through global-reaching clinical research, we encourage you to apply. This position is remote. Duties include: Prepare regulatory submissions (such as IRB and IND/IDE) and applications and annual reports. Complete all related regulatory documents and maintain correspondence and telephone contacts with regulatory agencies. Submit annual reports and updates as required. Serve as expert liaison in specialized compliance or scientific area between the investigators and regulatory agencies. Provide regulatory support, guidance, and information to principal investigators and research staff. May consult on protocol development. Oversee and maintain regulatory documentation, safety reporting procedures and audit safety reports to ensure they are appropriately handled. Evaluate and analyze the impact on new regulations and determine how to implement within unit. Apply knowledge of international, federal, state and local regulations as well as university policies to ensure optimal compliance. Serve as primary liaison on safety issues and reporting procedures with the IRB, OSR, RMG or other internal organizations or committees. May manage projects related to regulatory activities and clinical operations, develop the regulatory strategy for project teams. May hire, orient, and provide ongoing training and direct supervision to regulatory staff. Assign work tasks, provide daily supervision of these tasks; provide verbal and written evaluation of work performance. May contribute to establishing and developing Standard Operating Procedures for the conduct of clinical research. Ensure SOPs are compliant with international, federal, state, and local regulations, and consistent with the objectives of the clinical research operation. The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned. DESIRED QUALIFICATIONS: Demonstrated excellent communication skills in speaking and writing. Experience in Cell Immune Therapy is preferred. 2-4 years of clinical research experience is a plus. Comfortable working independently. EDUCATION & EXPERIENCE (REQUIRED): Bachelor's degree and five years of related experience or a combination of education and relevant experience. KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED): Excellent communication and organizational skills and superb attention to detail. Experience with MS Office products and database applications required. Excellent inter-personal skills and customer service focus is required. Experience in clinical research management and oversight, including project management in a dynamic research setting. Strong knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good Clinical Practice. Experience in developing and implementing training/education. Demonstrated ability to manage multiple projects and staff under varying time constraints. Strong writing skills. PHYSICAL REQUIREMENTS: Frequently sit, grasp lightly, use fine manipulation and perform desk-based computer tasks, lift, carry, push pull objects that weigh to ten pounds. Occasionally sit, use a telephone or write by hand. Rarely kneel, crawl, climb, twist, bend, stoop, squat, reach or work above shoulders, sort, file paperwork or parts, operate foot and hand controls. Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job. WORKING CONDITIONS: May require occasional local and overnight travel. WORKING STANDARDS: Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations. Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned. Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, This role is open to candidates anywhere in the United States. Stanford University has five Regional Pay Structures. The compensation for this position will be based on the location of the successful candidate. The expected pay range for this position is $83,000 to $119,000 per annum. Stanford University provides pay ranges representing its good faith estimate of what the university reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location and external market pay for comparable jobs. At Stanford University, base pay represents only one aspect of the comprehensive rewards package. The Cardinal at Work website provides detailed information on Stanford's extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process. Why Stanford is for you Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Our culture and unique perks empower you with: Freedom to grow. We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a renowned author or global leader speak. A caring culture. We provide superb retirement plans, generous time-off, and family care resources. A healthier you. Climb our rock wall, or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits. Discovery and fun. Stroll through historic sculptures, trails, and museums. Enviable resources. Enjoy free commuter programs, ridesharing incentives, discounts and more. Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Additional Information Schedule: Full-time Job Code: 4942 Employee Status: Regular Grade: I Requisition ID: 100464 Work Arrangement : Remote Eligible