IRB Specialist

Location
Rockville, Maryland
Salary
Competitive
Posted
Feb 13, 2021
Closes
Mar 15, 2021
Ref
2777
Function
Other
Industry
Science
Hours
Full Time
The Emmes Company, LLC ("Emmes") is searching for an IRB Specialist . Emmes provides flexibility for the office location or work remote preference dependent upon position.

Emmes is a Contract Research Organization (CRO). Headquartered in Rockville, Maryland, Emmes employs over nine 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

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 IRB Specialist will support the established NCI CIRB.

Responsibilities
  • Provide support to CIRB Coordinators for the management of multiple IRBs
  • Provide administrative and logistical support before, during and after convened CIRB meetings
  • Process expedited continuing and amendment reviews
  • Contribute to the monthly progress report
  • Draft and distribute letters to institutions
  • Distribute continuing review reminder notices
  • Schedule IRB review of studies
  • Maintain a record of all documents posted to the CIRB website
  • Upload files and data into regulatory file database, as needed and requested
  • Assist with additional tasks as needed


Experience
  • Bachelor's Degree and related experience in health-related field; oncology clinical trial environment preferred. Years of experience will be considered in lieu of degree.
  • 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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