The Stanford Innovative Neurotherapeutics Center, or SINC, is a new center at Stanford University and the Lucile Packard Children's Hospital dedicated to advancing treatments for devastating neuropsychiatric disorders. Stanford University is seeking a Clinical Trial Regulatory lab manager (Clinical Trials Regulatory Specialist 2) to be responsible for the administration and regulatory compliance of clinical research within SINC, and representing the university with external regulatory agencies, both domestic and international.
DESIRED QUALIFICATIONS:
Experience with working with human subjects in clinical trials/clinical research for at least 5-6 years including oversight of recruitment, enrollment, study close out, sponsor correspondence, and PI support.
Experience with University IRB
Experience with NIH/NIMH regulatory processes
Strong communication skills both written and verbal.
Understanding of the Clinical Trial process from beginning to end including experience managing critical NIH interactions, trial site management, and working with commercial and institutional review boards (IRB).
Experience working with the National Institutes of Health (NIH) and/or industry/external Sponsors.
Demonstrated problem-solving abilities in managing clinical sites and demonstrated tactfulness and diplomacy in communicating with investigators, participants, and study coordinators.
This position is a 1-year fixed term.
Core Duties:
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.
Develop, deliver and manage tools to facilitate education and training, prepare written materials to communicate with research community including presentations, one-on-one training and orientation sessions.
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.
Minimum Education and Experience
Bachelor’s degree and five years of related experience or a combination of education and relevant experience.
Knowledge, Skills and Abilities:
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.