Job Description:
• 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.
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