Associate, Compliance & QA – IRB

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

📋 Description

• Assists in the development of eReview Manager.

• Aids in testing, validation, and release processes for IRB software systems and associated technology platforms.

• Designs and executes User Acceptance Testing (UAT) scripts, documenting testing outcomes and findings.

• Develops and sustains testing, training, and process documentation to facilitate system implementation and adoption.

• Monitors defects, enhancement requests, and project action items until resolution.

• Collaborates with business, technical, and operational stakeholders to confirm requirements and enhance system functionalities.

• Aids in end-user training, communications, and change management initiatives related to technology projects.

• Contributes to the ongoing development, maintenance, and enforcement of the IRB Quality Management System.

• Supports senior compliance team members in establishing and upholding IRB quality standards.

• Assists and promotes efforts to realize IRB quality objectives, goals, and process enhancements.

• Mentors and trains WCG staff on IRB quality department standards and best practices.

• Collaborates with WCG IRB staff to draft and update internal standards and related documents.

• Ensures that standards comply with relevant regulatory agency regulations and guidance.

• Guarantees that standards are accessible to employees for training purposes.

• Leads designated tasks and provides quality oversight concerning the implementation and/or development of WCG businesses.

• Ensures that the implementation, development, and release of controlled documents align with GxP, GDPR, HIPAA, and regulatory guidance.

• Initiates and coordinates the periodic review and/or for-cause modifications to SOPs and Policies.

• Manages the review and posting of desk helps, templates, auto texts, minutes language, COA phrases, and other controlled documents.

• Internally posts IRB panel rosters.

• Aids in the investigation and resolution of subject/third-party inquiries and complaints.

• Creates, tracks, and maintains complaints and records in the database until resolution.

• Prepares and maintains routine reports concerning subject inquiries/complaints.

• Coordinates with other departments to resolve issues and ensures staff and the Board receive appropriate information.

• Ensures thorough investigation of events and proper maintenance of documentation.

• Supports ISO 9001 certification activities and participates in certification reviews/annual surveillance audits.

• Assists in the preparation of certification documentation.

• Conducts internal audits/periodic reviews of WCG processes and procedures.

• Identifies compliance gaps and offers remediation support and recommendations.

• Reports on the quality status of staff, systems, and production activities to leadership.

• Assists with IRB roster management and OHRP/FDA registration.

• Collects roster updates, reviews, generates, and posts courtesy rosters; maintains WCG IRB OHRP/FDA registration.

• Manages ComplianceWire accounts for new community IRB members, including account creation, curriculum assignment, and welcome/orientation communications.

• Assists Board members with ComplianceWire account-related issues.

• Supports the hosting of external audits and inspections, including preparation, report review, response collection, and follow-up on findings resolution.

• Performs other duties as assigned by the supervisor.

⛳️ Requirements

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

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

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

• Understanding of drug development and the clinical trial process.

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

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

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

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

• Capacity to solve problems and facilitate conflict resolution.

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

• Desired certifications for quality professionals through the Society for Quality Assurance and the American Society for Quality or similar certifications.

• Travel requirement of 0% - 5%.

🏝️ Benefits

• Comprehensive benefits package, including 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 support community involvement.

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