Institutional Review Board - Baystate Health
Category(s): Research, Institutional Review Board
Full Time / Part Time: Full-Time
The IRB Analyst is responsible for implementing and coordinating the daily activities of the IRB including provision of support to the HRPP Director, the IRB Manager, the IRB Chair, and IRB Members.
The IRB Analyst functions as a resource to research investigators and staff. The IRB Analyst 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 Analyst is responsible for analyzing all submissions to the IRB for completeness, accuracy, ethical and regulatory compliance. The IRB Analyst is responsible for IRB record retention. The IRB Analyst is responsible for maintaining complete IRB protocol files.
1) The IRB Analyst position includes all responsibilities of the IRB Coordinator.
2) Whereas the IRB Coordinator assists the IRB Manager with many functions, the IRB Analyst functions with minimal supervision from the IRB Manager and demonstrates significant autonomy and judgment.
3) Takes an active role in HRPP and institutional process development and improvement.
4) May take the administrative lead on special projects as assigned by the HRPP Director and IRB Manager.
5) Assists the HRPP Integrity and Education Specialist in compliance activities including study reviews, external audit preparation, and policy development and revisions.
6) The IRB Analyst reviews submissions for issues of ethics and regulatory compliance and advises the IRB Chairs, HRPP Integrity and Education Specialist, and IRB Members.
7) The IRB Analyst makes recommendations for issue resolution in collaboration, and implements corrective actions as appropriate, in collaboration with other members of the HRPP and IRB
8) The IRB Analyst reviews and contributes to IRB policies and procedures.
Required Work Experience:
1) Minimum of 5 years of effective and relevant work experience with an HRPP, IRB, or research in a comparable regulatory environment
Preferred Work Experience:
1) None Listed
Skills and Competencies:
1) Strong computer skills and proficient in current Windows environment; experience with relational databases; word processing; electronic scheduling and mail
2) Web design and editing experience preferred
3) Excellent organizational skills, meticulous attention to detail
4) Excellent oral and written communication skills
5) Strong knowledge or ability to develop a strong knowledge of Federal and State research regulations and AAHRPP guidelines
6) Able to work collaboratively with the IRB Manager and HRPP and IRB staff in a fast-paced environment with closely spaced deadlines
7) Ability to function independently and exercise good judgment
8) Ability to multitask including to prioritize and reprioritize quickly and accurately
9) Ability to work effectively with difficult customers
10) Ability to work in team settings and create effective partnerships
11) Due to sensitive and/or confidential nature of HRPP and 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.
Bachelor of Arts (Required)
Certified Institutional Review Board Professional – Institutional Review Board
Equal Employment Opportunity Employer
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.