The Department of Psychiatry and Behavioral Sciences at Stanford University School of Medicine is seeking a Clinical Trials Regulatory Manager to join our team. Our department has a large and diverse scientific portfolio and our research is accelerating and expanding each day. We are committed to ensuring that our investigators and all learners not only have exposure to the foundations of GCP, but also the opportunity to implement best research practices in all clinical research. In this exciting role, you will work closely with Department leadership on creating and implementing a program of best research practices within the Department. Using new software and tools, we seek to provide actionable and relevant information to investigators to ensure that local, State, and Federal guidelines are being adhered to and that study engagement is aligned with internal and external regulatory agencies, both domestic and international. Together with School leadership, we are building a robust clinical research infrastructure and are looking for a team leader to join us!
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.
Lead efforts, authorize and manage submissions to internal and external agencies. Provide final review and approval for submissions and reports.
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.
* - Other duties may also be assigned
Previous experience with FDA IND regulations, clinicaltrials.gov and the Common Rule
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor’s degree and five years of related experience including two years of supervisory experience or a combination of relevant education and 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.
CERTIFICATIONS & LICENSES:
ACRP and/or SOCRA certifications desired.
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.
Additional PHYSICAL REQUIREMENTS: WORKING CONDITIONS:
May require occasional local and overnight travel.
Internal Number: Requisition ID: 86163
About Department of Psychiatry and Behavioral Sciences at Stanford University School of Medicine
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