Senior Regulatory Specialist
Stanford University - Stanford, CA
posted 16 days ago
About the position
The Sean N. Parker Center for Allergy and Asthma Research at Stanford University is seeking a Senior Regulatory Specialist to manage the oversight of all regulatory activities under the direction of project researchers, investigators, or managers. The Sr Regulatory Specialist will join a team of researchers that leads or participates in many clinical trials to develop new therapies for allergic disorders and immune conditions. The studies include a wide range of patients, representing a diverse group of ethnicities and socioeconomic backgrounds. The Center is aiming not only to find better treatments for children and adults with allergies and asthma, but to discover underlying immune mechanisms against the diseases and develop a lasting cure. Primary responsibilities as a Sr Regulatory Specialist will include the oversight and management of all regulatory activities including overseeing IRB submissions, prompt reporting, annual reports to the IRB, DSMB, and FDA, and mentoring the research staff on regulatory topics to ensure Center adherence to all regulatory aspects of all SNP Center studies and grants.
Responsibilities
- Lead the planning and operations for programs or functions that have significant business, regulatory and/or technical challenges requiring subject matter expertise.
- Evaluate programs or functions, policies and procedures. Identify issues, and develop alternative solutions which may include changes to programs, policies and procedures.
- Review and analyze trends to advise and develop recommendations to achieve or modify the goals of the program or function.
- Represent the program or function within the department, unit or school. Commit resources and provide information and/or training.
- Manage and contribute to the development of outreach strategy that may include relationship development, communications and compliance.
- May develop and/or oversee budgets; manage finances including monitoring, analyzing, forecasting, and reporting.
- Assess training needs and may develop associated training.
- May direct and/or supervise staff.
- Other duties may also be assigned.
Requirements
- Bachelor's degree and five years of relevant experience, or combination of education and relevant experience.
- Demonstrated ability to establish priorities, manage shifting priorities, and handle numerous time-sensitive projects with multiple deadlines.
- Ability to accomplish goals working through formal and informal channels, with diplomacy and tactfulness.
- Demonstrated creativity, problem solving, critical analysis, initiative, judgment and, decision-making skills.
- Demonstrated ability to develop and meet budget goals.
- Demonstrated solid planning and organizational skills.
- Demonstrated experience working independently and as part of a team.
- Excellent interpersonal, written and oral communication skills.
- Strong relevant subject matter knowledge.
- Ability to direct the work of others, for jobs requiring supervision.
Nice-to-haves
- Experience in managing the Investigator Site File for complex, multi-site studies as Site Sponsor.
- Certified Clinical Research Professional (CCRP).
- Certified in Clinical Research Monitoring.
- Experience submitting and managing Investigational New Drug (IND) applications.
Benefits
- Events and program for children, sports camps, tuition options.
- World-class intellectual stimulation through learning and development classes, workshops, and onsite conferences from leading-edge speakers and faculty.
- Work/life and family-friendly policies and reimbursement.
- Participation in Stanford's social responsibility and sustainable programs for a better world.
- A vibrant university culture that values the uniqueness of each individual.
