Clinical Trials Regulatory Specialist 2
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 2 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 2 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 the Manager of Regulatory Operations, the Clinical Trials Regulatory Specialist 2 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 excellentcommunication 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:
- 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.
* - 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 five years of related experience or a combination of relevant education and 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.
- 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.
- Schedule: Full-time
- Job Code: 4942
- Employee Status: Regular
- Grade: I
- Department URL: http://cancer.stanford.edu/
- Requisition ID: 87512