Research - Laboratory/Non-Laboratory, Staff/Administrative
Clinical Trials Regulatory Specialist 1
Job Number: 86151
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.
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. 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.
Location: School of Medicine, Redwood City, California, United States Schedule: Classification Level:
Stanford is an equal opportunity employer and all qualified applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by law.
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Located between San Francisco and San Jose in the heart of Silicon Valley, Stanford University is recognized as one of the world's leading research and teaching institutions. Leland and Jane Stanford founded the University to "promote the public welfare by exercising an influence on behalf of humanity and civilization." Stanford opened its doors in 1891, and more than a century later, it remains dedicated to finding solutions to the great challenges of the day and to preparing students for leadership in a complex world. The University's thriving diverse community is comprised of nearly 7000 undergraduate students, 12000 graduate students, 2000 faculty members, 1900 postdoctoral scholars, and over 11,000 academic and administrative staff in seven schools including several interdisciplinary research centers and institutes. The campus spreads over 8000 contiguous acres and nearly all undergraduates live on campus. Stanford offers bachelor's and master's degrees in addition to doctoral degrees (PhD, MD, DMA and JD) plus a number of professional and continuing education programs and certifications. More at http://facts.stanford.edu and http://www.stanford.edu. Stanford is an equal empl...oyment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stanford also welcomes applications from others who would bring additional dimensions to the University’s research, teaching and clinical missions.