IRB Local Context Coordinator

Location
Rockville, Maryland
Salary
Competitive
Posted
Nov 07, 2019
Closes
Dec 07, 2019
Ref
2261
Function
Other
Industry
Science
Hours
Full Time
The Emmes Company, LLC ("Emmes") is searching for an IRB Local Context Coordinator located in our Rockville, Maryland, Frederick, Maryland and/or Tysons Corner, Virginia offices. Emmes provides flexibility for office location preference, dependent upon position.

Emmes is a private Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over six hundred staff worldwide with offices located in Frederick, Maryland, Tysons Corner, Virginia, 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

In support of the NCI CIRB, Emmes provides logistical and IT support in addition to ongoing monitoring and review of scientific, ethical, and regulatory compliance in human subject research projects for NCI's Clinical Trials Programs. The Local Context Coordinator will support the established NCI CIRB.

Responsibilities

  • Communicating with sites through the CIRB Helpdesk toll-free number and email and answering any questions they may have
  • Coordinating CIRB enrollment efforts for those clinical sites that wish to participate in the CIRB
  • Assisting sites in the enrollment efforts including, but not limited to, explaining the CIRB in detail, assisting sites with completion of enrollment documents, and assisting sites in utilizing the CIRB
  • Providing local context administrative review of sites' IRB submissions to the CIRB
  • Educating sites regarding new policies and procedures
  • Organizing and facilitating site-specific conference calls to discuss more complex topics that need additional conversation
  • Participating in a CIRB booth at large conferences/meetings to answer questions about the CIRB
  • Providing cross-coverage to other aspects of CIRB Outreach


Experience

  • Bachelor's Degree and related experience in health-related field; oncology clinical trial environment preferred
  • Minimum 2 years' IRB experience
  • 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 protocol 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 Company, LLC 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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