The Blood and Marrow Transplantation & Cellular Therapy (BMT-CT) program at Stanford performs autologous and allogeneic transplantations for over 300 patients each year. The program has been very successful with a history of limited morbidity rates and acute mortality that is well below most published reports. In addition to a successful clinical practice, our program researchers are translating their discoveries into new therapies, advancing the efficacy of hematopoietic cell transplantation for patients worldwide.
BMT-CT is seeking a Clinical Trials Regulatory II Specialist to support a very active clinical trials faculty. The position will anticipate and generate reports and prepare documents for submission as required by the IRB, FDA, OSP and APB requirements, including annual reports, and IND safety reports. The position will author and submit new applications according to CFR 21 Part 312 including Investigator New Drug (IND) applications, revisions, amendments, and Informed Consent documents in support of BMT-CT clinical research and coordinate with the Stanford Cancer Clinical Trials Office (CCTO) for submission to the FDA according to established procedures. The position will gather, evaluate, organize and manage information from a variety of sources to draft/finalize biomedical research protocols during the development phase, including draft content and formatting to meet requirements of Stanford, Institutional Review Board (IRB), United States Food and Drug Administration (FDA), Office of Science Policy (OSP) and APB (Biosafety Committee).
Duties include:
- Prepare regulatory submissions (such as IRB and IND/IDE) and applications and annual reports. Complete all related regulatory documents and maintain correspondence and telephone contacts with regulatory agencies. Submit annual reports and updates as required.
- Serve as expert liaison in specialized compliance or scientific area between the investigators and regulatory agencies. Provide regulatory support, guidance, and information to principal investigators and research staff. May consult on protocol development.
- Develop, deliver and manage tools to facilitate education and training, prepare written materials to communicate with research community including presentations, one-on-one training and orientation sessions.
- Oversee and maintain regulatory documentation, safety reporting procedures and audit safety reports to ensure they are appropriately handled.
- Evaluate and analyze the impact on new regulations and determine how to implement within unit. Apply knowledge of international, federal, state and local regulations as well as university policies to ensure optimal compliance.
- Serve as primary liaison on safety issues and reporting procedures with the IRB, OSR, RMG or other internal organizations or committees.
- May manage projects related to regulatory activities and clinical operations, develop the regulatory strategy for project teams.
- May hire, orient, and provide ongoing training and direct supervision to regulatory staff. Assign work tasks, provide daily supervision of these tasks; provide verbal and written evaluation of work performance.
- May contribute to establishing and developing Standard Operating Procedures for the conduct of clinical research. Ensure SOPs are compliant with international, federal, state, and local regulations, and consistent with the objectives of the clinical research operation.
DESIRED QUALIFICATIONS:
- Experience with Protocol/IND writing.
- Experience with BMT-CT disease focus.
EDUCATION & EXPERIENCE (REQUIRED):
- Bachelor’s degree and five years of related experience or a combination of education and relevant experience.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Excellent communication and organizational 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 research management and oversight, including project management in a dynamic research setting.
- Strong knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good Clinical Practice.
- Experience in developing and implementing training/education.
- Demonstrated ability to manage multiple projects and staff under varying time constraints.
- 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.
WORKING CONDITIONS:
- May require occasional local and overnight travel.
WORKING 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/.
Why Stanford is for You
Imagine a world without search engines or social platforms. Consider lives saved through first-ever organ transplants and research to cure illnesses. Stanford University has revolutionized the way we live and enrich the world. Supporting this mission is our diverse and dedicated 17,000 staff. We seek talent driven to impact the future of our legacy. Our culture and unique perks empower you with:
- Freedom to grow. We offer career development programs, tuition reimbursement, or audit a course. Join a TedTalk, film screening, or listen to a renowned author or global leader speak.
- A caring culture. We provide superb retirement plans, generous time-off, and family care resources.
- A healthier you. Climb our rock wall or choose from hundreds of health or fitness classes at our world-class exercise facilities. We also provide excellent health care benefits.
- Discovery and fun. Stroll through historic sculptures, trails, and museums.
- Enviable resources. Enjoy free commuter programs, ridesharing incentives, discounts and more.
