IRB Coordinator PD

Summary:

This role is part of the Lifespan Human Research Protection Program. The IRB Coordinator ensures that all research activities comply with federal regulations state and local law and institutional policies and AAHRPP accreditation standards in the conduct of biomedical and behavioral human subject research activities conducted by Lifespan employees or research affiliates.

The role actively participates in the development and revision of departmental Standard Operating Procedures under the supervision of a HRPP Manager. The role works closely with the IRB Chairs and reports directly to a Manager Lifespan Human Research Protection Office.

Responsibilities:

Perform timely screening/review of submissions to ensure completeness and conformance with HRPP SOPs. Provide pre-review for incoming submissions requiring administrative non-committee review and select expedited review determine adequacy of applications and level of review required select reviewers for protocol reviews follow-up with IRB reviewers to assure appropriate level of review provided and prepare outcome letters and finalized documents through electronic submission system. Includes responsibility of conducting certain non-committee administrative reviews as applicable.

Provide education and training on use of IRB electronic management system with the research community.

Timely communication with investigators/study team regarding IRB submissions.

Monitor the Office's general email inbox and respond to requests for information complaints and concerns

Maintain and ensure retention of all required IRB records communications and other documents.

Maintains a knowledge and understanding of current federal state regulations state and local law and institutional policy and departmental SOPs.

Participate in continuing education and national and/or regional organizations devoted to promoting research ethics and the protection of human subjects.

Assist in training of new IRB personnel.

Assists on special projects as needed.

Must work independently possess ability to educate and act as a resource to fellow staff.

Other information:

BASIC KNOWLEDGE:

Associates Degree in business science or related field with course work or demonstrated experience in office systems development interpersonal communications medical terminology.

In lieu of Associates Degree two or three years of experience in research administration compliance and regulation is appropriate.

EXPERIENCE:

One (1) year related experience in IRB administration clinical research or human subject protection regulatory compliance or research related job.

This experience may include working with research investigators IRB submissions processing approvals IRB meeting minutes demonstrating knowledge of and ability to interact related requirements of the sponsor and federal regulations.

Basic knowledge of federal regulations pertaining to research HIPAA ICH GCP at a level sufficient to function independently as a consultant to clinical investigators.

Basic knowledge of clinical/behavioral research.

Basic knowledge of medical terminology

Intermediate experience in Microsoft office software including Office Word and Excel.

Experience in electronic IRB systems or comparable software/system.

SUPERVISORY RESPONSIBILITY:

None.

Lifespan is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race color religion sex national origin age ethnicity sexual orientation ancestry genetics gender identity or expression disability protected veteran or marital status. Lifespan is a VEVRAA Federal Contractor.

Location: Corporate Headquarters USA:RI:Providence

Work Type: Per Diem

Shift: Shift 1

Union: Non-Union