Clinical Trials Regulatory Lab Manager

Stanfordlivetickets; Palo Alto (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

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.

This position is a 1-year fixed term and based at the Stanford Innovative Neurotherapeutics Center (SINC) in Palo Alto.

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.

Skills

Clinical trials oversight

IRB experience

NIH/NIMH processes

Communication skills

Regulatory coordination

Sponsor correspondence

Trial site management

NIH interactions

Problem-solving

Diplomacy with investigators

Job description

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 beresponsible 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.