IRB Manager (RCM1)
IRB Manager (RCM1)
Job Number: 76370
If you have experience with regulatory affairs and institutional review boards (IRBs) and have excellent customer service skills, you may be the right match for this IRB Manager position. Stanford University's IRB is charged with ensuring that all aspects of Stanford's Human Research Protection Program comply with all applicable laws, regulations, and policies, including standards of excellence necessary for maintaining accreditation status. This position, which is core to Stanford's research compliance activities, focuses primarily on medical Research. Under the direction of the Sr. HRPP Manager and the IRB Chair, the IRB Manager conducts in-depth protocol review using advanced regulatory knowledge and experience. S/he has primary responsibility to manage the protocol review process and identify issues, and to independently determine whether the components of the proposed research are in compliance with federal, state and local regulations, Stanford University policies, and accreditation standards. Other duties include serving as an expert liaison between the research investigator and the reviewer; educating parties on relevant and emerging regulations, and identifying related risk management issues Core Duties:
- Develop, implement, and manage efficient procedures to facilitate the processing of human/animal research protocols in accordance with Stanford, federal, accreditation, and state policies and procedures.
- Perform review of complex research protocols, including identifying problems and issues in the submission application and contacting the investigator orally or in writing to request additional materials.
- Plan and coordinate IRB review and follow-up activities.
- 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.
- Provide assistance to management in preparation for accreditation and in various compliance and quality assurance activities.
- Bachelor's degree and three years of relevant experience, or combination of education and relevant experience.
- Excellent customer service skills and ability to use tact and discretion.
- Comprehensive knowledge of regulations and ethical principles regarding human subjects in research.
- Demonstrated understanding of research procedures terminology, medical terminology, clinical trials, and research data management.
- In-depth understanding of operational requirements pertaining to management and implementation of protocol process.
- Strong knowledge of grants and contracts function.
- Demonstrated strong verbal and written communication skills.
- Institutional Review Board Professional Certification (CIP) desirable.
- Frequently perform desk based computer tasks, seated work and use light/ fine grasping.
- Occasionally stand, walk, and write by hand, lift, carry, push pull objects that weigh up to 10 pounds.
Job: Compliance Legal
Location: Dean of Research
To be considered for this position please visit our web site and apply on line at the following link: stanfordcareers.stanford.edu
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.