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Associate, Compliance & QA – IRB
Location
United States
Posted
4 days ago
Salary
$52.5K - $81.5K / year
Seniority
Mid Level
Job Description
Associate, Compliance & QA – IRB
WCG
• Assists and supports the Compliance team in establishing and maintaining quality assurance standards and measures across WCG services organization and ensuring compliance with regulatory requirements and best practices. • Performs 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. • Supports the continued development, maintenance, and enforcement of the IRB Quality Management System. • Assists senior compliance team members to establish and enforce IRB quality standards. • Coaches and trains WCG staff on IRB quality department standards and best practices. • Ensures the implementation, development, and release of controlled documents in line with regulatory agency regulations and guidance, including but not limited to, GxP, GDPR, and HIPAA. • Supports the investigation of subject/third party inquiries, maintains confidentiality and handles all matters discreetly. • Assists in the preparation of certification documentation in cooperation with appropriate business stakeholders.
Job Requirements
- Bachelor’s degree or the equivalent combination of education, skills, and experience to perform the job.
- Certifications for quality professionals through the Society for Quality Assurance and the American Society for Quality or comparable certifications are desirable.
- Two (2) to four (4) 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.
- Knowledge and understanding of drug development and the clinical trial process.
- Experience in training others in standards and ensuring compliance with employee education and Learning Management Systems (LMS).
- Effective communication (written and oral) skills including strong technical writing skills.
- Demonstrated organizational skills with the ability to work efficiently and independently.
- Excellent interpersonal skills as well as the ability to interact with WCG staff and clients.
- Ability to solve problems and engage in the resolution of conflicts.
- Proficiency with a Learning Management System (LMS) as well as Microsoft Office
Benefits
- Comprehensive Benefits package - Health, Dental, Vision, Life Disability, 401k with match, and flexible spending accounts
- Employee Assistance Programs and additional work/life resources
- Referral Bonuses and Tuition Reimbursement
- Flexible PTO
- Volunteer Time Off to benefit the community
- Opportunities for career development with on-the-job training, certification assistance, and continuing education reimbursement
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