IRB Analyst I
Tufts University is a leading institution in research and innovation, and they are seeking an IRB Analyst I to support their Social, Behavioral & Educational Research Institutional Review Board. The role involves ensuring compliance with regulations for human subjects research and managing key aspects of the IRB review and approval process.
Responsibilities
- Conduct preliminary triage of all eIRB submissions and assign them to IRB staff for review
- Apply federal regulations, state and local laws, and institutional policies to initial submissions, continuing reviews, and modifications
- Make determinations regarding 'not human subjects research,' engagement, and exempt research under supervision
- Conduct preliminary reviews of expedited research and assign to designated reviewers
- Review investigator responses to IRB stipulations, assess adequacy, and complete approvals as appropriate
- Communicate review outcomes to investigators promptly and clearly
- Assign and distribute materials for expedited and convened meeting reviews
- Review designated reviews for completeness and compliance with regulatory requirements
- Assist with meeting preparation, post-meeting communications, and record-keeping
- Respond to email and phone inquiries from investigators and research staff
- Provide instruction and regulatory guidance on IRB submissions and the electronic system
- Support training and educational presentations in collaboration with senior IRB staff
- Build positive relationships with the research community to promote compliance and effective communication
- Maintain documentation of IRB reviews and communications in accordance with federal regulations and institutional policies
- Perform quality checks on data entered in the electronic IRB system
- Generate reports for the Institutional Official and other university departments under supervision
- Participate in continuous improvement initiatives and implement new or revised processes under supervision
- Stay current on evolving regulations and best practices in human subjects research oversight
Skills
- Knowledge and experience typically acquired through completion of a Bachelor's degree or equivalent experience in a related field
- Minimum of 1 year of administrative experience
- Excellent interpersonal, written, and oral communication skills
- Strong attention to detail
- Excellent organizational skills with demonstrated ability to multitask efficiently, meet deadlines, and respond to ad hoc requests in a timely manner
- Ability to handle confidential information and issues with discretion and sound judgment
- Ability to learn software systems related to IRB administration and oversight
- Critical thinking skills and ability to work effectively with diverse internal and external constituencies
- IRB or human subjects research experience
- CIP (Certified IRB Professional) certification
- Familiarity with Huron IRB software solution for protocol management
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