IRB Coordinator

Req#: R23001
Category(s): Research, Institutional Review Board
Full Time / Part Time: Full-Time
Shift: First

Summary: 

The IRB Coordinator functions under the supervision of the IRB Manager and 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.

Job Responsibilities: 

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

2)  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.

3) 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.

4) Tracks the researcher's compliance with the institutional requirements for participation in research, including training in human subjects protections.

5) 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.

6) Assists IRB Director 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 the preparation of IRB meeting minutes. Maintains complete and accurate HRPP records. Acts as a substitute for the IRB Analysts

7)  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.

8)  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.

9)  Assists on special projects as assigned by the HRPP/IRB Director and perform administrative duties in support of the IRB operations

10) Administratively maintain IRB documentation in OnCore, logs, tracks and support the workflows for IRB studies.

Required Work Experience: 

1) Minimum of 2 years of effective and relevant work experience in HRPP, IRB, or research in a comparable regulatory environment preferred

Preferred Work Experience: 

1) Research in a comparable regulatory environment preferred

Skills and Competencies: 

Strong computer skills and proficiency in current Windows environment; experience with relational databases, word processing; electronic scheduling and mail. Web design and editing experience preferred. Excellent organizational skills, and 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 prioritizing and reprioritizing quickly and accurately. Ability to work effectively with difficult customers. Ability to work in team settings and create effective partnerships. Due to the sensitive and/or confidential nature of HRPP/IRB issues, maturity of judgment, tact, and sensitivity are required for successful job performance.

You Belong At Baystate

At Baystate Health we know that treating one another with dignity and equity is what elevates respect for our patients and staff. It makes us not just an organization, but also a community where you belong. It is how we advance the care and enhance the lives of all people.

DIVERSE TEAMS. DIVERSE PATIENTS. DIVERSE LOCATIONS.

Education:

Non-Graduate (Required)

Certifications:

Certified Institutional Review Board Professional – Institutional Review Board

Equal Employment Opportunity Employer

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