Clinical Trials Regulatory Specialist
Independently develop, draft and compile research protocol documents and all materials required for regulatory submissions in compliance with University and external policies.
Clinical Trials Regulatory Specialist
Job Number: 80230
The Department of Psychiatry and Behavioral Sciences, at Stanford University School of Medicine, is seeking a Clinical Trials Regulatory Specialist to be responsible for the administration and regulatory compliance of clinical research in the department. The Regulatory Specialist will act as a Department-resource for expertise and guidance on all aspects of clinical trials.
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.
Location: School of Medicine, California, United States
To be considered for this position please visit our web site and apply on line at the following link: stanfordcareers.stanford.edu
Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.
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