IRB Administrator

Location
Rockville, Maryland
Posted
Nov 03, 2018
Closes
Dec 08, 2018
Function
Administrative
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 are dedicated to providing statistical and epidemiological expertise, computer systems deployment, data management, study monitoring, regulatory guidance, and overall operational support to clients engaged in biomedical research. Emmes offers 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 IRB Administrator to support the National Cancer Institute’s Central Institutional Review Board (CIRB).

 

Responsibilities

  • Leading the day-to-day support of the CIRBs by assisting and managing approximately 6 project staff Monitoring CIRBs to ensure appropriate continuity and constancy in operations and reviews between both staff and board reviews Overseeing all CIRB related activities related to CIRB reviews in accordance with FDA, OHRP, NIH, and other government regulatory directives/guidance Managing timelines for continuing reviews and ensuring that all submissions are reviewed, approved and posted prior to the CIRB expiration date Generating reports regarding Board Operations on multiple various management topics Assisting in the maintenance of effective communications with the coordinating groups, CIRB Operations Office staff, and relevant CTEP and DCP Contractors/Branches/Initiatives Assisting in the implementation of Project Management Plan for the CIRB initiative Providing orientation, training and continuing education to staff and CIRB members Contributing to process and quality improvement efforts Responding to Helpdesk tickets and inquiries from sites and coordinating groups which require regulatory expertise and guidance Communicating with National Cancer Institute Project Officers (POs) and attending meetings involving timelines, contract deliverables and task requests Prioritizing work and/or negotiate with POs and CIRB staff to meet needs and deadlines Assisting Emmes Principal Investigators and Contracts in managing the project budget Assisting in the continued development of internal workflows Assisting with additional tasks as needed

Experience

 

  • Master’s Degree in a research related field with 4 plus years or a Bachelor’s degree with 6 plus years of managerial experience under federal contracts with documented evidence of successful management of complex projects or major project components Experience in Regulations and Federal Guidance’s regarding IRBs required Certified IRB Professional (CIP) in good standing, or the ability to obtain CIP within 12 months Experience with oncology clinical trials preferred

 

 

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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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