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Posted: Thursday, August 29th, 2019
JOB TITLE: IRB Coordinator (Remote or On Site)
DEADLINE: Monday, September 30th, 2019
LOCATION: Prime Review Board
Rockfille, MD, United States
CONTACT: Toby Schonfeld
EMAIL: info@primereviewboard.com
TELEPHONE: 301-296-5943
DETAILS:
As a full-service independent IRB, Prime reviews human subjects research, consults on ethically-optimal study design, participant recruitment, consent processes and provides ethical and regulatory guidance & oversight to its clients. The IRB Coordinator will support the established Prime IRB.

Responsibilities

Assists in development of new and revision of existing policies and procedures in support of the single IRB
Works with the IRB Chair and members to ensure that all research and related items submitted to the IRB are reviewed and acted upon in a timely manner in accordance with IRB SOPs
Reviews submitted protocols and ensure compliance with federal regulations
Negotiates reliance agreements with research sites
Manages communications between the IRB, sponsors, PIs, site research teams and local IRBS, and the IRB office
Recommends primary and secondary reviewers for protocol review
Drafts and distributes IRB meeting agendas and protocol documents for review
Drafts and distributes IRB minutes in a timely manner per IRB SOPs
Documents the IRB’s determinations in letters and distribute to stakeholders
Files regulatory documents appropriately to maintain accurate and complete records of all IRB activities
Maintains databases for tracking studies and IRB submissions
Maintains current references on regulations and policies
Serves as a resource to the human subjects protection program to questions on preparing submissions and compliance with SOPs
Assists in the development of tools and educational resources to support the IRB’s review of research and training of IRB members
Coordinates expedited review of eligible submissions
Assists with additional tasks as needed
Other duties as assigned

Experience

BA or BS degree in a health-related field (Masters preferred)
2 years of experience in research administration in support of clinical/biomedical research and/or IRB experience in a health care environment
Single IRB experience strongly preferred
Independent decision making and the ability to make good judgements are critical
Knowledge of the federal laws and regulations governing the conduct of research with human subjects is essential (21 and 45 CFR)
Exceptional oral and written communication skills when interacting with the client and investigators submitting protocols to the IRB
Ability to learn and use complex computer systems/databases
Attention to detail and accuracy in reporting the actions of the IRB are essential

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