Research Compliance Office (RCO) Sr. Quality and Compliance Manager
Who are we?
The Research Compliance Office (RCO) is responsible for oversight and management of Stanford's Administrative (Compliance) Panels and ensures compliance with applicable policies, accreditation standards and external regulations. Our goal at RCO is to help facilitate research and to make sure it is done safely, ethically, and legally. We take pride in being service-oriented.
RCO is charged with ensuring that all aspects of the Human Research Protection Program (HRPP) and the Institutional Animal Care and Use Program (IACUP) comply with all applicable laws, regulations, and policies, including standards of excellence necessary for maintaining accreditation status. This position is core to Stanford's research compliance activities.
We are seeking a candidate experienced with regulatory affairs and the protection of human or animal subjects in research.
In this position, under the direction of the RCO Deputy Director, the Sr. Quality and Compliance Manager you will:
Partner closely with Research Compliance Office (RCO) leadership to promote a culture of quality assurance and continual ongoing learning in support of RCO's mission.
Collaborate with HRPP/IACUP senior managers and use his/her knowledge of regulations and processes to assess RCO's adherence to policies, procedures, and regulations.
Develop strategies to enhance efficiencies and streamlining of processes with an eye for consistency, and measure the quality and integrity of services delivered.
Coordinate with HRPP/IACUP managers to identify opportunities for education, outreach, and collaborate with the research community (e.g., Research Office, Cancer Center).
Other duties may include serving as an expert contact with research investigators and administrators; educating parties on relevant and emerging regulations, and supporting process improvement activities.
You will also:
Develop, implement, and manage efficient procedures to facilitate the processing of medical and protocols in accordance with Stanford, federal, accreditation, and state policies and procedures.
Perform review of complex research protocols, including identifying problems and issues. Recommend, design, and conduct reviews as necessary to ensure improvements are implemented.
Plan and coordinate monthly IRB/IACUC review and follow-up activities in order to drive consistency and streamlining effort throughout RCO. Advise on and support standardization and streamlining of processes wherever possible and appropriate, in line with best practices to ensure accuracy and compliance
Perform review of complex research protocols, including identifying potential issues in the submission application and contacting the investigator orally or in writing to request additional materials.
Serve as an expert liaison between the research investigator and the reviewer; educate parties on relevant and emerging regulations and related risk management issues.
Apply knowledge of federal, state, and local regulations, as well as university policies and practices, to ensure satisfactory compliance. Ensures HRPP and IACUP are in compliance with federal regulations, state laws, and Stanford policies. Manage official documents and procedures for easy updates, maintenance, and retrieval.
Provide assistance to management in preparation for accreditation and in various compliance and quality assurance activities. Advise RCO leadership on strategies for campus outreach and readiness, education and monitoring
Lead special projects or meetings on complex and sensitive issues; participate in multi-functional teams, and assist in implementing solutions in the various RCO groups.
Manage the work of other employees, recommend hiring or disciplinary actions, or provide coaching, training, and mentoring, as assigned.
*Please note this position may require the following:
Occasional work on evenings and weekends or on-standard hours based on project or business needs.
Occasional cross campus and local travel
Exposure to allergens, biohazards, chemicals, radiation or electromagnetic fields.
To be successful in this position, you will bring:
Bachelor's degree and five years of relevant experience, or combination of education and relevant experience.
Comprehensive knowledge of regulatory information regarding the use of human/animal participation in research and teaching.
Demonstrated understanding of the principles of human/animal research protection standards.
Strong knowledge of grants and contracts function.
Significant working knowledge of research procedures and terminology, medical terminology, clinical trials, and research data management.
In-depth understanding of operational requirements pertaining to management and implementation of protocol process.
Demonstrated strong verbal and written communication skills.
Advanced knowledge of human subjects/animal protections regulations and best practices, as evidenced by certification (e.g., Certified IRB Professional, Certified Professional IACUC Association)..
Knowledge of medical/scientific areas, such as gene transfer, HIV AIDS, stem cells, cellular biology, biosafety, health and safety, and epidemiology.
Direct IRB or IACUC experience, preferably with an Association for Accreditation of Human Research Participant Protection Programs or Association for Assessment and Accreditation of Laboratory Animal Care accredited institution.
In addition, our preferred requirements include:
Ability to obtain or retain Institutional Review Board or Institutional Animal Care and Use Committee professional certification.
* - The job duties listed are typical examples of work performed by positions in this job classification and are not designed to contain or be interpreted as a comprehensive inventory of all duties, tasks, and responsibilities. Specific duties and responsibilities may vary depending on department or program needs without changing the general nature and scope of the job or level of responsibility. Employees may also perform other duties as assigned.
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.
Stanford is an equal employment 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.
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.
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.