Human Subjects’ Clinical Research Regulatory Specialist
The Department of Psychiatry and Behavioral Sciences, at Stanford University School of Medicine, is seeking a Human Subjects’ Clinical Research Regulatory Specialist to be responsible for the administration and regulatory compliance of all human subjects-based clinical research in the Department. This candidate will be expected to act as the Department’s expert on all clinical trials related matter.
This position does not pertain to GLP, GMP, or wet-lab practices.
The Clinical Research Regulatory Specialist will be responsible for providing Department-level trainings on GCP (ALCOA, creation of study protocols, issues around informed consent, CONSORT, etc.). In addition, s/he will be required to hold recurring meetings with Research Managers and Clinical Research Coordinators to provide information on: proper conduct of human-subjects clinical research, how to translate FDA materials into behavioral studies, and any updates on new requirements and policies.
The Clinical Research Regulatory Specialist will oversee and manage Department clinical trials dot gov, OnCore (CTMS) entry, large-scale recruitment initiative, create/maintain reference materials on the department’s webpage, develop and implement clinical research SOPs and standardization of work flows. Please review the duties below for a full context of scope and responsibilities.
• Independently develop, 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.
• 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.
• May co-author 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
• Certified Clinical Research Coordinator with audit and GCP experience
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:
• 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.