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1+ months

IRB QA & Compliance Associate

WIRB-Copernicus Group (WCG)

General Information

Location: Cary, NC, Remote

Organization: WCG IRB

Job Type: Full Time - Regular

Description and Requirements

The IRB QA & Compliance Associate is responsible for assisting and supporting the Compliance team with respect to establishing and maintaining quality assurance standards and measures across WCG services organization and ensuring such standards comply with regulatory requirements and best practice. Perform quality process reviews to provide information to management regarding the effectiveness of WCG IRB systems; initiates and facilitates process improvement projects; consults with all staff on matters involving process changes. Research, investigate, and respond to subject inquiries/complaints. This position is responsible for working alongside the senior compliance team and WCG employees to ensure the IRB organization remains compliant with WCGs Quality Management System and business processes.

VACCINATION REQUIREMENT:

To be considered for U.S.-based positions unless currently employed by WCG, where permitted by applicable law (including any applicable reasonable accommodation, medical or religious exemption), candidates must have received or be willing to receive the COVID-19 vaccine by start date.


EDUCATON REQUIREMENTS:
  • Bachelors degree or local equivalent in medicine, science, technology, or equivalent degree/experience

CERTIFICATIONS/LICENSE/REGISTRATION REQUIREMENTS:
  • Must obtain CIP or equivalent quality certification within 1 year of eligibility

QUALIFICATIONS/EXPERIENCE:
  • Two to five (2-5) years experience in a quality/regulatory compliance position with evidence of increasing responsibility.
  • Knowledge of current regulatory and GCP guidelines as they apply to clinical trials.
  • Significant technical writing skills.
  • Experience in training others on standards and ensuring compliance with employee education/LMS.
  • Effective communication (written and oral) skills, organization and interpersonal skills as well as the ability to interact with WCG staff and clients as needed.
  • Knowledge and understanding of drug development and the clinical trial process.
  • Ability to problem solve and engage in the resolution of conflicts.
  • Ability to work efficiently and independently.
  • Proficiency with a learning management system as well as MS Word, MS Excel, and MS PowerPoint.

ESSENTIAL DUTIES/RESPONSIBILITIES:
  • Support the continued development, maintenance, and enforcement of the IRB Quality Management System.
  • Engage with WCG IRB staff to author and revise internal standards and associated documents. 
  • Lead assigned work and provide quality oversight over the implementation, and/or development, of WCG businesses.
  • Support the investigation of subject/third party inquiries.
  • Oversee AAHRPP accreditation processes activities.
  • Assist with IRB roster management and OHRP/FDA registration.
  • Assist/support the hosting of external audits and inspections including internal audit preparation activities, review of audit report, collection of responses, and follow-up on findings resolution.

ABOUT US
For over 50 years, WCG IRB has been at the forefront of protecting the rights and welfare of human research participants during all phases of clinical trials.  Recognized as the gold standard of human subject protection, WCG is the trusted partner to over 1,000 institutions in the United States alone, ranging from small community hospitals and research sites to large academic medical centers and universities. Our unparalleled review ensures that human research studies withstand scrutiny around the world.
IND123
Posted: 2021-08-03 Expires: 2021-10-10

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IRB QA & Compliance Associate

WIRB-Copernicus Group (WCG)

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