Clinical Trials Regulatory Specialist
Job Code: 4941
Job Grade: H
The NCI-designated Stanford Cancer Institute brings together faculty with cancer-relevant expertise from four Schools, the Cancer Prevention Institute of California and 30 departments throughout the University. The Cancer Clinical Trials Office (CCTO) is an integral component of the Stanford Cancer Institute since it enables the objective of our cancer center, to translate research from the laboratory into the clinical setting. Clinical Trials Regulatory Specialist 1 will be part of the CCTO’s Regulatory team that assists faculty and clinical research staff with regulatory submissions to the Stanford University Panel on Human Subjects (known as the Institutional Review Board or IRB) and the NCI Central IRB (referred to as the CIRB).
- 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
- Experience submitting regulatory documents to the NCI CIRB, or other central Institutional Review Board.
- Ability to multi-task, manage, and report on up to 5 new studies and/or 7 amendments/revisions at one time.
- Knowledge of oncology and clinical research conduct desired.
- Experience developing and delivering training.
- Certification through a professional organization such as RAPS or SOCRA preferred.
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.
- 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.
- Interpersonal Skills: Demonstrates the ability to work well with Stanford colleagues and clients and with external organizations.
- Promote Culture of Safety: Demonstrates commitment to personal responsibility and value for safety; communicates safety concerns; uses and promotes safe behaviors based on training and lessons learned.
- Subject to and expected to comply with all applicable University policies and procedures, including but not limited to the personnel policies and other policies found in the University's Administrative Guide, http://adminguide.stanford.edu.