IRB Administator I

Tufts Medicine

1d

About The Position

This role focuses on performing work related to research and development of new products, innovation, and improvement of products and processes. It also supports the administration of research practices, working to achieve organizational goals, plans, priorities, and tracking investments, allocating resources, and making decisions regarding research administrative activities. This is a professional individual contributor role that may direct the work of other lower-level professionals or manage processes and programs. The majority of time is spent overseeing the design, implementation, or delivery of processes, programs, and policies using specialized knowledge and skills typically acquired through advanced education. It is an experienced-level role that applies practical knowledge of the job area, typically obtained through advanced education and work experience. The incumbent works independently with general supervision, addressing difficult but typically not complex problems, and may influence others within the job area through explanation of facts, policies, and practices. This position provides administrative support to the Institutional Review Board (IRB), assisting with activities related to reviewing, monitoring, and approving biomedical and social, behavioral, and educational research involving human subjects in a manner compliant with state and federal regulations. It supports IRB committee activities, leadership teams, the research community, and other key stakeholders.

Requirements

• Bachelor’s Degree.
• Two (2) years of experience in a clinical research environment or IRB Office.
• Excellent verbal and written communication skills.
• Excellent customer service skills.
• Ability to stay calm in high pressure situations.
• Ability to understand and share the feelings of others.
• Ability to show initiative, work autonomously, and to organize oneself.
• Ability to work in and thrive within a team environment.
• Ability to adapt to changing job demands.
• Ability to make reasoned judgments that are logical and well-thought out.
• Ability to demonstrate thoroughness and accuracy when accomplishing a task.
• Strong organizational capabilities.
• Ability to establish rapport, create a relationship of trust, and build collaborative relationships.
• Ability to respond to situations in an appropriate manner; behaving and knowing when to act according to the circumstances; professional discretion.
• Ability to navigate comfortably with different computer software and applications.
• Knowledgeable about federal and state regulations as well as institutional policies related to the protection of human subjects.
• Ability to prioritize multiple competing tasks.

Nice To Haves

• Advanced Degree.
• Five (5) years of experience in a clinical research environment or IRB Office.

Responsibilities

• Proficient with IRB Office procedures to provide high level support to the IRB committees, IRB Chair/Vice-Chairs, and research community.
• Coordinates exempt, expedited and convened meeting review of research, corresponds with Investigators and research teams to relay IRB Reviewer comments, and documents determinations appropriately.
• Pre-reviews IRB applications for consistency, completeness, and compliance with federal and state regulations and institutional policies before review by the IRB or designated IRB Reviewer.
• Prepares IRB approved material and maintains accurate IRB office study documentation.
• Pre-reviews amendments and reportable new information for on-going IRB approved studies and generates correspondence (approval letters or requests for additional information) to study PIs.
• Attends scheduled IRB meetings, as needed. Records the actions, discussion and deliberations of the IRB.
• Generates and processes approval letters for amendments, addenda, and modifications.
• Determines appropriate review procedures for information received by the IRB and appropriately triages, i.e., expedited, full committee.
• Maintains current and accurate information in the IRB office to ensure appropriate record retention.
• Attends seminars, workshops and conferences in order to gain insight into new trends in human research and to learn new approaches for the application of federal regulations, particularly in an atmosphere of changing regulations, advancing technology, and increasingly complex ethical questions.
• Assists in developing, recommending, and implementing policies and procedures to enhance the efficiency of the IRB Office and IRB operations.
• Assists IRB leadership and office staff colleagues, as appropriate on special projects.
• Communicates with Principal Investigators (PI) and/or research team members to obtain required materials and/or clarifications.
• Renders a preliminary judgment regarding disposition for review and provides additional information, resources, and guidance to IRB reviewer(s) to ensure compliance with institutional requirements and policies regarding submissions.
• Contacts PIs and/or research team members in a timely manner to request clarifications or revisions, as needed, based on the determinations of the IRB reviewer(s).
• Provides ongoing consultation to investigators on issues pertaining to human subject protections and the IRB review process.
• Manages and coordinates continuing education program about human subject protections for IRB members, IRB staff and investigators.
• Presents education sessions and seminars, etc., for the research community.
• Leads in the development and implementation of job-related policies and procedures to enhance efficiency of office operations.
• Assists with internal IRB audits.
• Leads development of web-based materials that support the IRB, including educational materials, policies and procedures.
• Provides positive and effective customer service that supports IRB operations.
• Mentors and trains IRB Office colleagues, as needed.
• Maintains collaborative team relationships with peers and colleagues in order to effectively contribute to the working group’s achievement of goals, and to help foster a positive work environment.
• Notifies PI, as needed, of incomplete research applications that would delay the IRB review process.

Benefits

• Tufts Medicine provides a comprehensive Total Rewards package that supports your health, financial security, and career growth—one of the many ways we invest in you so you can thrive both at work and outside of it.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 501-1,000 employees