• Employment Type: Full Time
• Shift: Days
• Hours: 8:30 - 5
• Location: Boston, MA

PRINCIPAL DUTIES AND ESSENTIAL FUNCTIONS:

• Learns IRB Office procedures to provide 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.
• Reviews and is familiar with federal and state regulations as well as institutional policies related to the protection of human subjects.
• 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. Notifies PI, as needed, of incomplete research applications that would delay the IRB review process.
• Verifies that research teams have met the institutional educational requirements.
• Generates and processes IRB correspondence. 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. Maintains a list of documentation reviewed and notifies the reviewing Chair/Vice-Chairs IRB by including this list on the next agenda.
• Attends scheduled IRB meetings, as needed. Records the actions, discussion and deliberations of the IRB. Conveys the notice of the IRB comments in written correspondence to the study PI.
• Generates and processes approval letters for amendments, addenda, and modifications. Forwards validated materials, appropriately dated, to the study PI.
• 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.
• Provides assistance to IRB leadership and office staff colleagues, as appropriate on special projects
• Communicate with Principal Investigators (PI) and/or research team members to obtain required materials and/or clarifications
• Render a preliminary judgment regarding disposition for review and provide additional information, resources, and guidance to IRB reviewer(s) to ensure compliance with institutional requirements and policies regarding submissions
• Contact 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. Provides advice on issues related to the development of human subject research protocols, consents, and IRB submissions. Advises investigators on regulations and institutional policies.
• Assists in the implementation of a continuing education program about human subject protections for IRB members, IRB staff and investigators.
• Presents or assists in presenting education sessions and seminars, etc., for the research community.
• Assist in developing, recommending and implementing job-related policies and procedures to enhance efficiency of office operations.
• In conjunction with computer professionals and the IRB Supervisor, helps develop and maintain web-based materials that support the IRB, including educational materials, policies and procedures.
• Provide positive and effective customer service that supports IRB operations.
• Assists IRB Office colleagues, as needed
• Maintains collaborative team relationships with peers and colleagues in order to effectively contribute to the working groups achievement of goals, and to help foster a positive work environment.
• Performs other similar job related duties as required or directed.
• Maintains patient confidentiality per HIPAA regulations and keeps study information in a safe and secure location. Adheres to FDA Good Clinical Practice Guidelines.

Requires high level skills including the following:

• Communication: Excellent verbal and written communication skills
• Customer Focused: Excellent customer service skills
• Cool Under Pressure: The ability to stay calm in high pressure situations; the ability to prioritize multiple competing tasks
• Empathy: The ability to understand and share the feelings of others
• Self-Directed: The ability to show initiative, work autonomously, and to organize oneself
• Team Player: The ability to work in and thrive within a team environment
• Flexibility and Adaptability: The ability to adapt to changing job demands
• Critical Thinking Skills: The ability to make reasoned judgments that are logical and well-thought out
• Attention to detail: The ability to demonstrate thoroughness and accuracy when accomplishing a task
• Coordination: strong organizational capabilities
• Connection and Collaboration: The ability to establish rapport, create a relationship of trust and build collaborative relationships
• Professionalism: The ability to respond to situations in an appropriate manner; behaving and knowing when to act according to the circumstances; professional discretion
• Computer skills: The ability to navigate comfortably with different software and applications.

EDUCATION:

Bachelors degree

EXPERIENCE:

0 to 2 years (or equivalent) experience in a clinical research environment or IRB office preferred.

All your information will be kept confidential according to EEO guidelines.

AMERICANS WITH DISABILITIES STATEMENT:

Must be able to perform all essential functions of this position with reasonable accommodation if disabled.

The above statements are intended to describe the general nature and level of work being performed. They are not intended to be construed, as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. Tufts Medical Center reserves the right to modify position duties at any time, to reflect process improvements and business necessity.

COVID-19 POLICY:

Please note that effective October 1, 2021, as a condition of employment at Tufts Medical Center, all employees and new hires must have received their complete dose of the COVID-19 vaccine, unless they have been granted an exemption.