Institutional Review Board (IRB) Scientific Minutes Writer

Location
Rockville, Maryland
Salary
Competitive
Posted
Apr 25, 2019
Closes
Apr 25, 2019
Ref
2077
Function
Other
Industry
Science
Hours
Full Time
Emmes is searching for an IRB Scientific Minutes Writer located in our Frederick or Rockville, Maryland office. Emmes has offices located at the below locations and throughout the greater Washington, DC area with 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 Institutional Review Board (IRB) Scientific Minutes Writer will support writing meeting minutes for four IRBs within the National Cancer Institute's Central Institutional Review Board (CIRB).

Responsibilities
  • Write minutes for six board meetings a month plus any ad hoc meetings that occur
  • Ensure all regulatory requirements are captured in the meeting minutes and that any special considerations from a review are documented thoroughly
  • Identify and raise questions regarding review during the meeting to ensure the minutes accurately capture the discussion and determinations of the board
  • Review submissions and reviewer comments prior to the meeting to ensure understanding of the reviews on the agenda
  • Serve as a resource to the human subjects protection program to questions on compliance with SOPs and regulations
  • Provide draft minutes to the CIRB Coordinator or Administrator within required timeline;
  • Assist with additional tasks as needed

Experience
  • Bachelor's Degree and related experience in health-related field; oncology clinical trial environment 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)
  • Three years of experience writing IRB meeting minutes
  • Exceptional oral and written communication skills
  • Ability to learn and use complex computer systems/databases
  • Attention to detail and accuracy in reporting the actions of the boards are essential


Emmes has an outstanding benefits package including: generous tuition reimbursement, professional development and training programs

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Emmes 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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