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IRB Coordinator

Job ID 84580 Full / Part Time: Full-Time
Location: Springfield, Massachusetts
Regular/Temporary: Regular

Our Human Research Protection Program is seeking a full time IRB Coordinator!

Summary:  

The IRB Coordinator functions under the supervision of the IRB Manager is responsible for implementing and coordinating the daily activities of the IRB including providing support to the HRPP Director, the IRB Manager, IRB Analysts, the IRB Chair, and IRB Members.

The IRB Coordinator functions as a resource to research investigators and staff.  The IRB Coordinator is responsible for providing clear and accurate instructions, guidance, and support to researchers through the entire regulatory process. This includes assistance in creating successful and compliant applications for Institutional Review Board (IRB) review.  The IRB Coordinator is responsible for conducting an initial review of all submissions to the IRB for completeness, accuracy, and regulatory compliance.  The IRB Coordinator is responsible for IRB record retention. The IRB Coordinator is responsible for maintaining complete IRB protocol files as well as Research Credentialing file records of investigators and research staff.

What You Will Do: 

Maintains up-to-date knowledge of Federal and State regulations and Association of Human Research Protection Programs (AAHRPP) guidelines.

Serves as a resource to investigators and research staff.  Assists with preparing study protocols, informed consent documents, and regulatory documents including the BMC electronic submission process for submission to the IRB, Sponsored Programs Administration (SPA), external sponsors, contract research organizations, regulatory agencies, and other entities in a skilled and timely manner.  Responds to queries from principal investigators and staff in a skilled and timely manner.

Logs and tracks research applications to the IRB database; completes the initial review of all new studies submitted for full IRB review; verifies that the appropriate required documentation is present and has been completed correctly, accurately, and thoroughly; obtains amplifying and clarifying information and materials from Principal Investigators and staff when needed.  Renders a preliminary judgment regarding disposition for IRB review.  Maintains compliance with institutional requirements and policies regarding submission for new studies.

Tracks researchers compliance with the institutional requirements for participation in research including training in human subjects protections.

Completes and maintains CIP or CIM certification within 1 year of eligibility.  Attends training workshops, seminars, and conferences for continuing education on IRB and HRPP matters and for job enrichment.

Assists IRB Manager and Analysts with organization and preparation of IRB meetings, including preparation of the meeting agenda.  Attends IRB meetings as assigned and records actions and votes of the IRB after each monthly meeting.  Prepares response letters to Principal Investigators after IRB meetings.  Assists with preparation of IRB meeting minutes. Maintains complete and accurate HRPP records.

Functions with flexibility and willingness to meet the business needs of the HRPP, the IRB, and the Division of Academic Affairs including attending IRB meetings and assisting Principal Investigators and research staff at their convenience, which requires some early mornings and evening hours.

Acts as liaison with other hospital and system departments and committees on behalf of or as assigned by the IRB Manager to facilitate compliance with regulatory and institutional requirements.  Maintains collaborative, team relationships with peers and colleagues in order to effectively contribute to HRPP achievement of goals and foster a positive work environment.

Assists on special projects as assigned by the IRB Manager and the Research Integrity & Education Specialist.

What You Will Need: 

Minimally Required Education:

Preferred Education:  Bachelor's Degree preferred, but equivalent experience is acceptable

Minimally Required Experience: Minimum of 2 years of effective and relevant work experience in HRPP, IRB, or research in a comparable regulatory environment preferred

Preferred Experience: Research in a comparable regulatory environment preferred

Skills / Competencies:  Strong computer skills and proficient in current Windows environment; experience with relational databases; word processing; electronic scheduling and mail.  Web design and editing experience preferred.  Excellent organizational skills, meticulous attention to detail.  Excellent oral and written communication skills.  Strong knowledge or ability to develop a strong knowledge of Federal and State research regulations and AAHRPP guidelines.  Able to work collaboratively with the IRB Manager and HRPP and IRB staff in a fast-paced environment with closely spaced deadlines.  Ability to function independently and exercise good judgment.  Ability to multitask including to prioritize and reprioritize quickly and accurately.  Ability to work effectively with difficult customers.  Ability to work in team settings and create effective partnerships.  Due to sensitive and/or confidential nature of HRPP/IRB issues, maturity of judgment, tact and sensitivity are required for successful job performance.

Baystate Health is an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, marital status, national origin, ancestry, age, genetic information, disability, or protected veteran status.

For a complete listing of all Baystate Health jobs, or to access an incomplete application, click here

Trouble applying or uploading a resume? We invite you to email us at talent.acquisitionFD@baystatehealth.org or call us at 413-794-3666.

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