Clinical Trials Regulatory Lab Manager

SLAC; Palo Alto (CA); Sur place; USD 110 000 - 150 000; Plein temps

Résumé du poste

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

Responsabilités

• 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.

Connaissances

Clinical trial coordination

IRB experience

NIH regulatory knowledge

Written and verbal communication

Clinical site management

Sponsor correspondence

Regulatory compliance

Description du poste

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.