Clinical Trials Regulatory Lab Manager
Stanford University · Stanford
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.
Responsible for ensuring compliance with policies and procedures in accordance with mandated federal laws and regulation for clinical trials and human subjects.More jobs at Stanford University · Healthcare & Care jobs in Stanford