Institutional Review Board (IRB) Analyst

Location
Rockville, Maryland
Posted
Jul 11, 2018
Closes
Jul 12, 2018
Function
Analyst
Industry
Science
Hours
Full Time

The EMMES Corporation, established in 1977, is a privately-owned Contract Research Organization (CRO). Headquartered in Rockville, Maryland Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Vancouver, Canada and Bangalore, India. Ranked as a top area workplace of choice by the Washington Post, Emmes fosters an environment of collaboration, professional growth, and exceptional work life balance.

Our studies impact public health initiatives on a global scale occurring in more than sixty countries spanning across six continents. We offer statistical support for the entire process of clinical trials from study design and protocol development through data analysis and manuscript generation.

Primary Purpose

EMMES is seeking an Institutional Review Board (IRB) Analyst to support the expanding activities of a newly created IRB. The IRB Coordinator will support the establishment of this new central IRB. This position can work from either our Rockville, MD or Frederick, MD office, potential remote based work opportunity, for experienced IRB professionals outside the DC Metro.

Primary Responsibilities:

  • Assist in development of new and revision of existing policies and procedures in support of the IRB

  • Working 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

  • Review submitted protocols and ensure compliance with federal regulations

  • Manage communications between the IRB, Sponsor, Study Chairs, and IRB Operations Office

  • Recommends primary and secondary reviewers for protocol review

  • Draft and distribute IRB meeting agendas and protocol documents for review

  • Draft and distribute IRB minutes in a timely manner per IRB SOPs

  • Document the IRB’s determinations in letters and distribute to stakeholders

  • File regulatory documents appropriately to maintain accurate and complete records of all IRB activities

  • Maintain databases for tracking studies and IRB submissions

  • Maintain current references on regulations and policies

  • Serve as a resource to the human subjects protection program to questions on preparing submissions and compliance with SOPs

  • Assist in the development of tools and educational resources to support the IRB’s review of research and training of IRB members

  • Coordinate expedited review of eligible submissions

  • Assist with additional tasks as needed

Requirements:

  • BA degree preferred

  • At least one year of IRB experience required

  • 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

CONNECT WITH US!!

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The EMMES Corporation is an equal opportunity affirmative action employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, political affiliation, sexual orientation, gender identity, marital status, disability, protected veteran status, genetic information, age, or other legally protected characteristics.

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