Senior Project Manager, RECOVER Study

The Stanford Brain Stimulation lab within Stanford University’s Department of Psychiatry & Behavioral Sciences is seeking a Clinical Trials Regulatory Specialist 2 to be responsible for the administration and regulatory compliance of clinical research within the lab.  The CTRS 2 will represent the Brain Stimulation lab within the University as well with external regulatory agencies, both domestic and international. 

Interested candidates should upload their resume/CV and a cover letter outlining their experience in relation to the position.

DESIRED QUALIFICATIONS:

• Master’s degree
• Experience writing IND & IDE applications
• Experience with University IRB and well as Commercial IRB
• Experience with NIH/NIMH regulatory processes.

EDUCATION & EXPERIENCE (REQUIRED):

• Bachelor’s degree and five years of related experience or a combination of relevant education and experience.

KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):

• Excellent communication and organizational skills and superb attention to detail.
• Experience with MS Office products and database applications required.
• Excellent inter-personal skills and customer service focus is required.
• Experience in clinical research management and oversight, including project management in a dynamic research setting. 
• Strong knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good Clinical Practice. 
• Experience in developing and implementing training/education.
• Demonstrated ability to manage multiple projects and staff under varying time constraints.
• Strong writing skills.

PHYSICAL REQUIREMENTS*:

• Frequently sit, grasp lightly, use fine manipulation and perform desk-based computer tasks, lift, carry, push pull objects that weigh to ten pounds.
• Occasionally sit, use a telephone or write by hand.
• Rarely kneel, crawl, climb, twist, bend, stoop, squat, reach or work above shoulders, sort, file paperwork or parts, operate foot and hand controls.

* - Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.

WORKING CONDITIONS:

• May require occasional local and overnight travel

WORK STANDARDS:

• Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
• Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
• Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu .

** - COVID VACCINE COMPLIANCE: Stanford University, in compliance with the Executive Order Ensuring Adequate COVID Safety Protocols for Federal Contractors, requires all faculty, staff, postdocs, and students to be fully vaccinated for COVID-19. If you are offered and accept a position with the Department of Psychiatry and Behavioral Sciences, proof of vaccination documentation must be provided upon hire and all members of the department are expected to comply with all appropriate safety protocols.