Clinical Trials Regulatory Lab Lead

SLAC; Palo Alto (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Stanford University’s SINC seeks a Clinical Trial Regulatory lab manager to oversee administration and regulatory compliance of clinical research within the center, representing the university with external regulatory agencies.

The role includes managing communications with NIH, sponsors, and IRBs, and supporting trial site operations. This is a 1-year fixed-term position based in Palo Alto.

Qualifications

• 5-6 years experience working with human subjects in clinical trials/clinical research, 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 NIH interactions, trial site management, and working with IRBs
• Experience working with NIH and/or industry/external Sponsors
• Demonstrated problem-solving abilities in managing clinical sites and communicating with investigators, participants, and study coordinators

Responsibilities

• Administer and ensure regulatory compliance of clinical research within SINC.
• Represent the university with external regulatory agencies, domestically and internationally.
• Support NIH interactions and trial site management as needed.

Skills

Clinical trial coordination

IRB experience

NIH regulatory knowledge

Written and verbal communication

Clinical site management

Sponsor correspondence

Regulatory compliance

Job description

Stanford University’s SINC seeks a Clinical Trial Regulatory lab manager to oversee administration and regulatory compliance of clinical research within the center, representing the university with external regulatory agencies.

The role includes managing communications with NIH, sponsors, and IRBs, and supporting trial site operations. This is a 1-year fixed-term position based in Palo Alto.