Clinical Trials Regulatory Specialist 1
Clinical Trials Regulatory Specialist 1🔍School of Medicine, Redwood City, California, United StatesNew📁Research📅2 days ago Post Date📅87822 Requisition #Clinical Trials Regulatory Specialist 1
The Stanford Cancer Institute (SCI) is one of an elite member of National Cancer Institute-Designated Comprehensive Cancer Centers in the country, and is a prominent, dynamic, growing and complex Institute within the Stanford University School of Medicine. The SCI actively works to build synergies and collaborations among faculty with cancer-relevant expertise from four Schools and over 30 departments across Stanford University. We seek a Regulatory Specialist to help us enact our mission to reduce cancer mortality through comprehensive programs of cancer research, treatment, education and outreach. Given the SCI’s mission, breadth, and depth, it employs over 320 staff members in a fast-paced, team-oriented, and forward-thinking environment with tremendous opportunities for personal and professional growth. The Cancer Clinical Trials Office (CCTO) is an integral component of the Stanford Cancer Institute since the vital work performed there enables our adult and pediatric cancer centers to translate research from the laboratory into the clinical setting. You will be working with an unparalleled leading edge community of faculty and staff who are fundamentally changing the world of health care in the cancer arena.
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). Reporting to Manager, Regulatory Operations, the Clinical Trials Regulatory Specialist will be conversant in the goals, mission and priorities of the Institute, and utilize this knowledge to perform job duties. We are seeking candidates with excellent communication skills and superb attention to detail. Our staff run toward challenges, and you will have a demonstrated history of doing the same with a high degree of professionalism, initiative and flexibility. Responsibilities include:• 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.
• 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.
• 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. * - 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. PHYSICAL REQUIREMENTS*:• 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. WORK STANDARDS:• 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.
- Schedule: Full-time
- Job Code: 4941
- Employee Status: Regular
- Grade: H
- Requisition ID: 87822