Quality and Compliance Manager

Employment Type

: Full-Time

Industry

: Miscellaneous



The Stanford Center for Clinical Research (SCCR) is a growing academic research organization within the Stanford Department of Medicine. Our mission is to advance impactful clinical research through quality operations. You will have the opportunity to contribute to a dynamic team that is discovering innovative solutions to improve health locally and globally-ranging from studies involving COVID and other infectious diseases, cardiovascular medicine, gastroenterology, and hospital medicine. We are seeking a Quality & Compliance Manager to be an integral member of our leadership team. This critical role is responsible for leading the planning and operations for quality management of Stanford single- and multi-site clinical research projects across therapeutic areas; as well as leading or supporting department or school-wide regulatory and quality initiatives (e.g., ClinicalTrials.gov). The team currently consists of five staff; and there is a growing need and request for new regulatory and quality management support. The Quality & Compliance Manager will collaborate closely with the Education & Training Manager, Associate Directors, and Clinical Research and Project Managers to identify and create workflows, operations manuals, and other tools to optimize streamlined, regulatory compliant, and quality operations. The ideal candidate has significant expertise clinical research regulations, strong attention to detail, excellent communication and relationship-building skills, and the ability to collaborate with diverse stakeholders. You may also have the opportunity to learn and contribute through additional collaborations throughout the School of Medicine. 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! Learn more about our work and core values: www.med.stanford.edu/sccr. Duties include: * Responsible for designing, developing, and implementing tools, processes and strategies of a moderate to complex nature to ensure regulatory compliance, improve, and streamline regulatory processes essential to the successful management of clinical research projects. * Oversee and manage projects related to regulatory activities and clinical operations, develop the regulatory strategy for project teams and maintain metrics. * 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. * Oversee, develop and facilitate educational and compliance training programs. * 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 a regulatory point of contact during audits. May act on behalf of Senior Management in regard to interactions with regulatory agencies. * Represent department or institute in interactions with external organizations such as industry sponsors or contract manufacturers and funding agencies, such as the National Institutes of Health. * Interact and advise senior management on clinical trials regulatory processes or decisions. * May have budget responsibility for day to day operations. * - 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: * Relevant certification in clinical research, GCP, and/or quality assurance. * Regulatory Affairs Certificate (RAC) * Significant regulatory expertise. * Relevant graduate degree. EDUCATION & EXPERIENCE (REQUIRED): * Bachelor's degree and five years of related experience including two years of supervisory experience or a combination of education and relevant experience. KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED): * Experience in clinical research management and oversight, including project management in a dynamic research setting. * Experience in a lead role and interactions with federal agencies, i.e. FDA. * Expert knowledge of regulatory affairs, including IRB review and approval process and Good Clinical Practice. * Knowledge of International Conference on Harmonization (ICH) standards. * Experience in developing and implementing multifaceted projects. * Excellent communication and organizational skills and superb attention to detail. * Experience with MS Office products and database applications required. * Strong written and verbal 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, http://adminguide.stanford.edu/. 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: 4944 * Employee Status: Regular * Grade: J * Requisition ID: 88803

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