Associate, Compliance & QA – IRB

Job not on LinkedIn

🔥 0 minutes ago

🇺🇸 United States – Remote

💵 $52.5k - $81.5k / year

⏰ Full Time

🟢 Junior

🟡 Mid-level

🔧 QA Engineer (Quality Assurance)

👻 Ghost score 0%

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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

• Supports the development of eReview Manager • Supports testing, validation, and release activities for IRB software systems and related technology platforms • Develops and executes User Acceptance Testing (UAT) scripts and documents testing results and findings • Creates and maintains testing, training, and process documentation to support system implementation and adoption • Tracks defects, enhancement requests, and project action items through resolution • Collaborates with business, technical, and operational stakeholders to validate requirements and support system improvements • Assists with end-user training, communications, and change management activities related to technology initiatives • 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 • Assists and supports efforts to implement IRB quality goals, objectives, and process improvements • Coaches and trains WCG staff on IRB quality department standards and best practices • Engages with WCG IRB staff to author and revise internal standards and associated documents • Ensures standards conform with applicable regulatory agency regulations and guidance • Ensures standards are made available to employees for training • Leads assigned work and provides quality oversight regarding implementation and/or development of WCG businesses • Ensures implementation, development, and release of controlled documents in line with GxP, GDPR, HIPAA, and regulatory guidance • Initiates and coordinates periodic review and/or for-cause changes to SOPs and Policies • Manages review and posting of desk helps, templates, auto texts, minutes language, COA phrases, and other controlled documents • Posts IRB panel rosters internally • Supports investigation and resolution of subject/third-party inquiries and complaints • Creates, tracks, and maintains complaints and records in the database through resolution • Prepares and maintains routine reports regarding subject inquiries/complaints • Coordinates with other departments to resolve issues and ensure staff and the Board have appropriate information • Ensures proper investigation of events and maintenance of documentation • Supports ISO 9001 certification activities and certification reviews/annual surveillance audits • Assists in preparation of certification documentation • Executes internal audits/periodic reviews of WCG processes and procedures • Identifies compliance gaps and provides remediation support and suggestions • Reports quality status of staff, systems, and production activities to leaders • Assists with IRB roster management and OHRP/FDA registration • Collects roster updates, reviews, generates, and posts courtesy rosters; maintains WCG IRB OHRP/FDA registration • Administers ComplianceWire accounts for new community IRB members, including account creation, curriculum assignment, and welcome/orientation emails • Assists Board members with ComplianceWire account issues • Supports hosting external audits and inspections, including preparation, report review, response collection, and follow-up on findings resolution • Performs other duties as assigned by supervisor

🎯 Requirements

• Bachelor’s degree or the equivalent combination of education, skills, and experience to perform the job • 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 • Certifications for quality professionals through the Society for Quality Assurance and the American Society for Quality or comparable certifications are desirable • Travel requirement of 0% - 5%

🏖️ 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