Clinical Trials Regulatory and Quality Specialist

Fixed Term 12 months

Stanford University is seeking a Clinical Trials Regulatory and Quality Specialist 1 to be Responsible for the administration and regulatory compliance of clinical research within the university.

Duties Include

• Assist in developing, draft and compile research protocol documents and all materials required for regulatory submissions in compliance with University and external policies.
• Manage and oversee new study initiation process, including educating study staff and sponsors, resolving issues and providing regulatory guidance and support.
• Facilitate and participate in committee meetings, ensure procedures are followed. Responsible for compiling, organizing, and storing all session documentation and communicating results as appropriate.
• Revise submissions for identified problems and issues and resolve any procedural issues that might arise in order to ensure timely response; advise investigator on remedies and revisions.
• Maintain regulatory documents, monitor and recommend improvements for tracking regulatory documents. May assist with registering and reporting of clinical trials, i.e. ClinicalTrials.gov.
• Assist with development and management of electronic data capture systems. Test data collection and export methods. Assist with data analaysis procedures.
• Collaborate on development of standard operating procedures, trainings, and documentation. May participate in delivering trainings.
• Stay current on federal, state, and local regulations regarding clinical research and communicate changes to study staff and recommend related changes to leadership.
• May serve as primary liaison on safety issues and reporting procedures with the IRB, OSR, RMG or other internal organizations or committees.
• Prepare committee responses to investigators, assure these are reviewed, signed by the Chairperson, and communicated promptly to the necessary parties.
• - Other duties may also be assigned
  
  

All members of the Department of Pediatrics are engaged in continuous learning and improvement to foster a culture where diversity, equity, inclusion, and justice are central to all aspects of our work. The Department collectively and publicly commits to continuously promoting anti-racism and equity through its policies, programs, and practices at all levels.

Stanford University provides pay ranges representing its good faith estimate of what the University reasonably expects to pay for a position. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location, and external market pay for comparable jobs. The pay range for this position working in the California Bay area is $97,137.00 to $109,320.00

Desired Qualifications

• Experience with Investigator Initiated (IIT) Clincial Trials
• Experience with study monitoring of data or regulatory records
• Experience developing processes, policies or Standard Operating Procedures
• Certification in clincial research (such as ACRP, SOCRA, Stanford CROP or other programs)
  
  

Education & Experience (required)

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

Knowledge, Skills And Abilities (required)

• Excellent communication 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 trials operations, knowledge of clinical trials regulatory requirements, or experience working with an IRB.
• Knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good Clinical Practice.
• Strong writing skills.
  
  

Certifications & Licenses

None

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.