CIRB Quality Assurance Specialist

Location
Rockville, Maryland
Posted
Aug 21, 2018
Closes
Aug 22, 2018
Function
IT, QA Engineer
Industry
Science
Hours
Full Time

CIRB Quality Assurance Specialist

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

The Central IRB (CIRB) Initiative is designed to help reduce the administrative burden on local IRBs and investigators while continuing a high level of protection for human research participants. A local IRB use of the CIRB facilitated a review mechanism enables an investigator to enroll patients into adult and pediatric Cooperative Group clinical trials significantly faster than when employing traditional method of IRB review. The CIRB Initiative is sponsored by NCI in consultation with the Department of Health and Human Services Office for Human Research Protections (OHRP). The Quality Assurance Specialist ensures that the NCI CIRB complies with the CIRB SOPs and federal regulations.

Responsibilities

  • Contributes to a quarterly audit schedule

  • Write audit plans and audit reports

  • Perform audits as defined by the quarterly audit and ad hoc audits; no travel required

  • Track audit results and findings and work within team to resolve audit findings

  • Provide recommendations for quality improvement efforts

  • Provide summary reports of trends based on audits

  • Assist with the development or review of Quality Assurance Plan; Quality Improvement Plan; internal work procedures; and checklists

  • Provide quality control review of letters and minutes for CIRB reviews

  • Assist with additional tasks as needed

Experience

  • Bachelor’s degree in a scientific discipline is preferred with at least 5 years of relevant IRB work experience; however in lieu of a degree the combination of experience and training will be taken under consideration
  • Understanding of OHRP (45 CFR 46) and FDA (21 CFR 50 and 21 CFR 56) regulations for IRBs
  • Experience with support of IRB operations
  • Excellent oral and written communication skills with the ability to effectively communicate and coordinate with internal and external clients
  • High attention to detail and change management
  • Excellent time management skills, prioritizing, problem solving, organization, decision-making, multi-tasking, diplomacy, planning, and good working knowledge of Microsoft Office

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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.