Clinical Trials Regulatory Lab Manager

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. 

Responsibilities

Core Duties:

• Prepare regulatory submissions (such as IRB and IND/IDE) andapplications and annual reports. Complete all related regulatorydocuments and maintain correspondence and telephone contacts withregulatory agencies. Submit annual reports and updates asrequired.

• Serve as expert liaison in specialized compliance or scientificarea between the investigators and regulatory agencies. Provideregulatory support, guidance, and information to principal investigatorsand research staff. May consult on protocol development.

• Develop, deliver and manage tools to facilitate education andtraining, prepare written materials to communicate with researchcommunity including presentations, one-on-one training and orientationsessions.

• Oversee and maintain regulatory documentation, safety reportingprocedures and audit safety reports to ensure they are appropriatelyhandled.

• Evaluate and analyze the impact on new regulations and determinehow to implement within unit. Apply knowledge of international, federal,state and local regulations as well as university policies to ensureoptimal compliance.

• Serve as primary liaison on safety issues and reportingprocedures with the IRB, OSR, RMG or other internal organizations orcommittees.

• May manage projects related to regulatory activities and clinicaloperations, develop the regulatory strategy for project teams.

• May hire, orient, and provide ongoing training and directsupervision to regulatory staff. Assign work tasks, provide dailysupervision of these tasks; provide verbal and written evaluation ofwork performance.

• May contribute to establishing and developing Standard OperatingProcedures for the conduct of clinical research. Ensure SOPs arecompliant with international, federal, state, and local regulations, andconsistent with the objectives of the clinical researchoperation.

Minimum Education andExperience

Bachelor’s degree and five years of related experience or acombination of education and relevant experience.

Knowledge, Skills and Abilities:

• Excellent communication and organizational skills and superbattention to detail.

• Experience with MS Office products and database applicationsrequired.

• Excellent inter-personal skills and customer service focus isrequired.

• Experience in clinical research management and oversight,including project management in a dynamic research setting.

• Strong knowledge of regulatory affairs, including FDAregulations, IRB review and approval process, and Good ClinicalPractice.

• Experience in developing and implementingtraining/education.

• Demonstrated ability to manage multiple projects and staff undervarying time constraints.

• Strong writing skills.