Clinical Trials Regulatory Specialist

Stanford University

Industry
Experience
Workhours
  • 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.
  • 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.
  • 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.
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Confirmed an hour ago. Posted 30+ days ago.

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