Informed Consent Document Analyst

Location
Rockville, Maryland
Salary
Competitive
Posted
Apr 05, 2019
Closes
May 05, 2019
Ref
2049
Function
Other
Industry
Science
Hours
Full Time
The Emmes Corporation, established in 1977, is a woman-owned, private 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 Informed Consent Document Analyst to support the National Cancer Institute's Central Institutional Review Board (CIRB) which currently supports four IRBs. The Informed Consent Document Analyst will review all consent forms submitted for the four IRBs.

Responsibilities
  • Review informed consent documents submitted for initial review and amendment reviews for four IRBs
  • Ensure informed consent documents are compliant with all applicable regulations as well as NIH or NCI policy
  • Ensure informed consent documents are compliant with the required templates utilized by the CIRB
  • Serve as a resource to the human subjects protection program to questions on compliance with SOPs and regulations especially related to informed consent documents
  • Identify issues and raise questions regarding informed consent documents related to the regulations and NCI requirements and communicate them effectively to applicable CIRB staff
  • Provide feedback regarding informed consent document review to the CIRB Coordinator, Administrator or Quality Control representatives within required timeline per the IRB SOPs
  • Assist with additional tasks as needed

Experience
  • Bachelor's Degree, preferably in a scientific or health-related discipline
  • Prior experience in an oncology clinical trial environment preferred
  • Independent decision making and the ability to make good judgments 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 working with IRBs, including experience reviewing informed consent documents
  • Exceptional oral and written communication skills
  • Ability to learn and use complex computer systems/databases
  • Attention to detail and accuracy in identifying the topics for discussion related to the informed consent document


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

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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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