IRB Quality Assurance/Quality Control Specialist

5 days left

Location
Rockville, Maryland
Salary
Competitive
Posted
Sep 10, 2022
Closes
Oct 10, 2022
Ref
3540
Function
Other
Industry
Science
Hours
Full Time
IRB Quality Assurance/Quality Control Specialist

US Remote Worker

The Emmes Company, LLC ("Emmes") is a global, full-service Clinical Research Organization dedicated to excellence in supporting the advancement of public health and biopharmaceutical innovation. We believe in the power of truth, so much so that we named our company Emmes, which means truth. Through decades of experience we have learned that collaborative relationships thrive and human health benefits when truth is our compass.

Our "Character Achieves Results" culture is driven by five key values that guide our actions in the way we conduct research and distinguish us as an organization: Integrity, Agility, Passion for Excellence, Collaborative Partnerships and Intellectual Curiosity. We are a trusted partner to clients who share our passion for improving public health in a world of ever-changing scientific research.

If you share our motivations and passion in research, come join us! You will be joining a collaborative culture that empowers every Emmes employee — from entry level through top executive — to contribute to our clients' success by sharing ideas openly and honestly.

Primary Purpose

EMMES is seeking a Quality Assurance (QA)/Quality Control (QC) Specialist to support the National Cancer Institute's Central IRB (CIRB) which currently supports four IRBs. The QA/QC Specialist will conduct audits and perform quality control checks for all four IRBs. This is a full-time position.

Responsibilities
  • Conduct QC review on all letters sent from the CIRB related to central review.
  • Conduct QC review of the six sets of minutes each month.
  • Conduct routine and ad hoc audits of CIRB operations. Recurring audits include review of CIRB expiration dates, review of Helpdesk responses, completeness and timeliness of minutes, and reporting of expedited review. Ad hoc audits are based on observations of areas that need further review and have the opportunity for improvement.
  • Ability to effectively communicate findings to team members.
  • Identify and raise questions regarding process concerns based on QC and QA reviews.
  • Serve as a resource to the human research protection program to questions on compliance with SOPs and regulations.
  • Contribute to the writing of the CIRB monthly report and the QA/QC Quarterly Report to capture the QA/QC activities that have been completed and that are ongoing.
  • Assist with additional tasks as needed.


Experience
  • Bachelor's Degree or equivalent experience in health-related field
  • At least 3 years of experience performing IRB support activities, required.
  • 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).
  • Exceptional oral and written communication skills.
  • Ability to learn and use complex computer systems/databases.
  • Ability to learn and apply QA/QC practices to improve the quality of audits and reviews within the CIRB operations office.
  • Attention to detail and accuracy when conducting QC checks and QA audits are essential.


Emmes is a federal government contractor and requires all employees to be fully vaccinated against COVID-19, to the extent permitted by applicable law. Individuals with medical conditions or sincerely religious beliefs or practices that prevent them from getting the vaccine may request an exemption from the vaccine requirement.

Why work at Emmes?

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

  • Unlimited Approved Leave


  • Tuition Reimbursement


  • 401k & Profit Sharing Plan
  • Work From Home Anywhere in the US


  • Maternal/Paternal Leave


  • Casual Dress Code & Work Environment


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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