Clinical Trial Regulatory
Stanford University is seeking a Clinical Trials Regulatory Specialist 1 to be Responsible for the administration and regulatory compliance of clinical research within the university y. The CTRS will be the subject matter expert on regulatory compliance for 12 Faculty members, 14 clinical research coordinators, 2 research administrators, and numerous nurses, and hospital staff involved in our active clinical trials and studies. BMT currently has 40 active clinical trials with many more coming soon. The CTRS will be responsible for regulatory compliance for all 40+BMT studies.
The BMT program at Stanford is fully accredited by the Foundation for the Accreditation of Cellular Therapy (FACT) and is a member of the BMT Clinical Trials Network of the United States. On November 2, 1987, the first adult patient underwent transplantation in our program, and since that day we have performed over 8,100 transplants. Our team is comprise of 12 Faculty Physicians, and a network of team members ranging from Finance and Administration, to Clinical Research Coordinators, Data Specialists, Nurses, APPS and social workers.
- 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
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.
- 1-3 years’ experience working on regulatory compliance and audits.
- Experience working with IRB, SRC, IND, writing protocols and regulatory SOPs.
- Experience working with Industry study monitors, and FDA audits.
- 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.