Associate, Compliance & QA – IRB

This is a fully remote position, open to applicants in United States.

📋 Description

• Aids and supports the Compliance team in the establishment and maintenance of quality assurance standards and measures throughout the WCG services organization, while ensuring adherence to regulatory requirements and best practices.

• Conducts quality process reviews to provide management with insights regarding the effectiveness of WCG IRB systems.

• Initiates and facilitates projects aimed at process improvement; collaborates with all staff on matters related to process modifications.

• Aids in the ongoing development, maintenance, and enforcement of the IRB Quality Management System.

• Assists senior compliance team members in establishing and enforcing quality standards for the IRB.

• Coaches and trains WCG personnel on the standards and best practices of the IRB quality department.

• Ensures the implementation, development, and release of controlled documents in accordance with regulations and guidance from regulatory agencies, including but not limited to GxP, GDPR, and HIPAA.

• Supports the investigation of inquiries from subjects or third parties, maintaining confidentiality and managing all issues with discretion.

• Assists in the creation of certification documentation in collaboration with relevant business stakeholders.

⛳️ Requirements

• A Bachelor’s degree or an equivalent combination of education, skills, and experience necessary to fulfill the job responsibilities.

• Certifications for quality professionals from the Society for Quality Assurance and the American Society for Quality, or similar certifications, are preferred.

• Two (2) to four (4) years of experience in a quality or regulatory compliance role, demonstrating increasing levels of responsibility.

• Familiarity with current regulatory and GCP guidelines as they relate to clinical trials.

• Understanding of drug development processes and the clinical trial methodology.

• Experience in training others on standards and ensuring compliance with employee education and Learning Management Systems (LMS).

• Strong communication skills (both written and oral), including proficient technical writing abilities.

• Proven organizational skills with the capacity to work efficiently and independently.

• Excellent interpersonal skills, with the ability to effectively interact with WCG staff and clients.

• Capability to troubleshoot and engage in conflict resolution.

• Proficiency in utilizing a Learning Management System (LMS) and Microsoft Office applications.

🏝️ Benefits

• Comprehensive benefits package including Health, Dental, Vision, Life Disability, 401k with matching contributions, and flexible spending accounts.

• Access to Employee Assistance Programs and additional work/life resources.

• Referral bonuses and tuition reimbursement opportunities.

• Flexible Paid Time Off (PTO).

• Volunteer Time Off to support community engagement.

• Opportunities for career advancement through on-the-job training, certification support, and reimbursement for continuing education.