Associate, Compliance & QA – IRB

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WCG

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

🏥 Healthcare

💊 Pharmaceuticals

☁️ SaaS

💰 Private Equity Round - WCG on 2019-11

Healthcare • Pharmaceuticals • SaaS

WCG is a global clinical research services and technology company that supports sponsors, CROs, research sites, and institutions across the lifecycle of clinical trials. Founded as a leader in independent ethical review, WCG provides IRB and IBC review, data monitoring committees, site enablement and study start-up services, participant recruitment and retention, and data & insights (including benchmarking, statistical consulting, and AI-powered trial foresight). The company also offers a suite of technology platforms (e. g. , ClinSphere®, eReview Manager, Total Enrollment, Total Feasibility) and large protocol and performance datasets to help design, plan, and run trials more efficiently and compliantly. WCG positions itself as a partner to biopharma and medical research organizations to accelerate trial activation, improve enrollment, and ensure regulatory and ethical compliance.

📋 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