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Job Profile** **Summary

•This role focuses on performing work related to research and development of new products, innovation, and improvement of products and processes. In addition, this role focuses on performing the following Research Administration duties: Supports the administration of research practices working to achieve the organization's practices goals, plans, priorities, and tracks investments, allocates resources and makes decision regarding research administrative activities. 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. An entry level role that applies broad theoretical job knowledge typically obtained through advanced education. May require the following proficiency: work is closely supervised, problems faced are not typically difficult or complex, and explains facts, policies and practices related to job area.

Job Overview

This position provides administrative support to the Institutional Review Board (IRB). Assists with the activities related to reviewing, monitoring, and approving biomedical and social, behavioral, and educational research involving human subjects in manner which is compliant to state and federal regulations pertaining to the use of human subjects in research. Supports IRB committee activities, leadership teams, research community, and other key stakeholders.

Job Description

Minimum Qualifications** **:

1. Bachelor’s degree.

2. One (1) year of experience in a clinical research environment

Preferred Qualifications** **:

1. Experience in an IRB office.

2. Two (2) years of experience in a clinical research environment.

**Duties and Responsibilities:** The duties and responsibilities listed below are intended to describe the general nature of work and are not intended to be an all-inclusive list. Other duties and responsibilities may be assigned.

1. Proficient with IRB Office procedures to provide high level support to the IRB committees, IRB Chair/Vice-Chairs, and research community.

2. Coordinates exempt, expedited and convened meeting review of research, corresponds with Investigators and research teams to relay IRB Reviewer comments, and documents determinations appropriately.

3. 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.

4. Prepares IRB approved material and maintains accurate IRB office study documentation.

5. 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.

6. Attends scheduled IRB meetings, as needed.

7. Generates and processes approval letters for amendments, addenda, and modifications.

8. Determines appropriate review procedures for information received by the IRB and appropriately triages, i.e., expedited, full committee.

9. Maintains current and accurate information in the IRB office to ensure appropriate record retention.

10. 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.

11. Assists in developing, recommending, and implementing policies and procedures to enhance the efficiency of the IRB Office and IRB operations.

12. Assists IRB leadership and office staff colleagues, as appropriate on special projects.

13. Communicates with Principal Investigators (PI) and/or research team members to obtain required materials and/or clarifications.

14. 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.

15. 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).

16. Provides ongoing consultation to investigators on issues pertaining to human subject protections and the IRB review process.

17. Manages and coordinates continuing education program about human subject protections for IRB members, IRB staff and investigators.

18. Presents education sessions and seminars, etc., for the research community.

19. Leads in the development and implementation of job-related policies and procedures to enhance efficiency of office operations.

20. Assists with internal IRB audits.

21. Leads development of web-based materials that support the IRB, including educational materials, policies and procedures.

22. Provides positive and effective customer service that supports IRB operations.

23. Mentors and trains IRB Office colleagues, as needed.

24. 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.

25. Notifies PI, as needed, of incomplete research applications that would delay the IRB review process.

Physical Requirements:

1. This is largely a sedentary role, which involves sitting most of the time, but may involve movements such as walking, standing, reaching, ascending/descending stairs, and operating office equipment.

2. Frequently required to speak, hear, communicate, and exchange information.

3. Ability to see and read computer displays, read fine print, and/or normal type size print and distinguish letters, numbers and symbols.

4. Requires manual dexterity using fine hand manipulation to operate computer keyboard.

Skills & Abilities:

1. Excellent verbal and written communication skills.

2. Excellent customer service skills.

3. Ability to stay calm in high pressure situations.

4. Ability to understand and share the feelings of others.

5. Ability to show initiative, work autonomously, and to organize oneself.

6. Ability to work in and thrive within a team environment.

7. Ability to adapt to changing job demands.

8. Ability to make reasoned judgments that are logical and well-thought out.

9. Ability to demonstrate thoroughness and accuracy when accomplishing a task.

10. Strong organizational capabilities.

11. Ability to establish rapport, create a relationship of trust, and build collaborative relationships.

12. Ability to respond to situations in an appropriate manner; behaving and knowing when to act according to the circumstances; professional discretion.

13. Ability to navigate comfortably with different computer software and applications.

14. Knowledgeable about federal and state regulations as well as institutional policies related to the protection of human subjects.

15. Ability to prioritize multiple competing tasks.

Tufts Medicine is a leading integrated health system bringing together the best of academic and community healthcare to deliver exceptional, connected and accessible care experiences to consumers across Massachusetts. Comprised of Tufts Medical Center, Lowell General Hospital, MelroseWakefield Hospital, Lawrence Memorial Hospital of Medford, Care at Home - an expansive home care network, and large integrated physician network. We are an equal opportunity employer and value diversity and inclusion at Tufts Medicine. Tufts Medicine does not discriminate on the basis of race, color, religion, sex, sexual orientation, age, disability, genetic information, veteran status, national origin, gender identity and/or expression, marital status or any other characteristic protected by federal, state or local law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation by emailing us at [email protected] .