Regulatory Specialist (Open To Remote) ($81000.00 - $115000.00 / Year)

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Stanford Department of Obstetrics & Gynecology's mission is to improve women's and reproductive health through innovative and compassionate care, education, advocacy and discovery. Our faculty is committed to the highest level of basic and clinical research in Obstetric and Gynecologic science. In particular, we are focused on innovative translational medicine; bringing scientific results from the bench to the bedside.

The Department is seeking Regulatory Specialist to support the regulatory and compliance needs of the growing number of research faculty in the Department. The Regulatory Specialist is expected to provide guidance and oversight on regulatory and compliance aspects of research varying from basic science research to clinical trials and population health research.

The Regulatory Specialist will be both working independently and as part of multidisciplinary teams of adept physicians, research scientists and research staff working to advance the science of women's and reproductive health.

This position can offer either remote or hybrid work arrangement.

More information about the department: obgyn.stanford.edu

Duties Include

• May hire, orient, and provide ongoing training and direct supervision to regulatory staff. Assign work tasks, provide dailysupervision of these tasks; provide verbal and written evaluation of work performance.
• May manage projects related to regulatory activities and clinical operations, develop the regulatory strategy for projectteams.
• Prepare regulatory submissions (such as complex IRB and IND/IDE) and applications and annual reports. Complete allrelated regulatory documents and maintain correspondence and telephone contacts with regulatory agencies. Submit annualreports and updates as required.
• Evaluate and analyze the impact on new regulations and determine how to implement within unit. Apply knowledge ofinternational, federal, state and local regulations as well as university policies to ensure optimal compliance.
• Oversee and maintain regulatory documentation, safety reporting procedures and audit safety reports to ensure they areappropriately handled.
• Serve as primary liaison on safety issues and reporting procedures with the IRB, OSR, RMG or other internal organizationsor committees.
• Serve as expert liaison in specialized compliance or scientific area between the investigators and regulatory agencies. Provideregulatory support, guidance, and information to principal investigators and research staff. May consult on protocoldevelopment.
• May contribute to establishing and developing Standard Operating Procedures for the conduct of clinical research. EnsureSOPs are compliant with international, federal, state, and local regulations, and consistent with the objectives of the clinicalresearch operation.
• Develop, deliver and manage tools like REDCap and OnCore to facilitate education and training, prepare written materials tocommunicate with research community including presentations, one-on-one training and orientation sessions.
• Other duties may also be assigned

Desired Qualifications

• Experience working with OnCore system
• Strong knowledge of REDCap system

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 inter-personal skills and customer service focus is required.
• Strong knowledge of regulatory affairs, including FDA regulations, IRB review and approval process, and Good ClinicalPractice.
• Strong writing skills.
• Demonstrated ability to manage multiple projects and staff under varying time constraints.
• Excellent communication and organizational skills and superb attention to detail.
• Experience with MS Office products and database applications required.
• Experience in developing and implementing training/education.
• Experience in clinical research management and oversight, including project management in a dynamic research setting.

PHYSICAL REQUIREMENTS*:

• Consistent with its obligations under the l
• Rarely kneel, crawl, climb, twist, bend, stoop, squat, reach or work above shoulders, sort, file paperwork or parts, operatefoot and hand controls.
• Occasionally sit, use a telephone or write by hand.
• Frequently sit, grasp lightly, use fine manipulation and perform desk-based computer tasks, lift, carry, push pull objects thatweigh to ten pounds.