Clinical Quality Assurance Associate

Are you looking for an exciting and fulfilling new position? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organization dedicated to advancing clinical research and transforming lives. Role Objectives: The Clinical Quality Assurance Associate supports the day-to-day management of the GCP related items within the Quality Management System (QMS) across all clinical activities, including decentralized clinical trials (DCTs) that involve nursing services and in-home patient care. This role ensures that all clinical and nursing operations are conducted in accordance with ICH GCP, applicable regulatory requirements, and internal SOPs. The Ideal Candidate: • Proactive and solutions-driven • Critical thinker • Cross-functional collaborator • Adaptable What You'll Do: • Ensure GCP compliance and promote best practices across all regulated activities. • Initiate and contribute to deviations, complaints, CAPAs, risk assessments, and validation protocols. • Investigate deviations and complaints, and follow up on CAPAs to ensure timely resolution. • Review clinical trial documents (e.g., protocols, ICFs, eCRFs) and essential records for accuracy. • Review eTMF for completeness and accuracy, working with staff to resolve any deficiencies. • Support clinical and nursing operations in managing QMS records, including change controls and risk management. • Identify root causes of quality issues and recommend appropriate solutions. • Assist in training staff on QMS components and relevant procedures. • Provide daily support on quality-related queries and maintain GxP documentation. • Support vendor qualification and requalification, including audit preparation and participation. • Contribute to internal audits and regulatory inspections as a subject matter expert. • Generate quality metrics, analyze trends, and support process improvements and validation strategies. What You'll Need: • Bachelor's Degree or higher (preference for pharmaceutical, life sciences, or engineering concentration) • 0-3 years of experience in a Quality-related role, with practical exposure to GCP activities. • Familiarity with eTMFs (e.g., Veeva Vault) and proficiency in Microsoft Office. • Strong organizational skills with keen attention to detail. • Knowledge of ICH GCP guidelines and relevant regulatory requirements (e.g., FDA). • Effective verbal and written communication skills. • Self-motivated and proactive, with strong interpersonal and critical thinking skills. • Able to manage multiple tasks and deadlines with accuracy. • Discreet and trustworthy with confidential information. • Experienced in cross-functional collaboration for investigations, root cause analysis, and process improvement. What We Offer: Medical, dental, and vision insurance, FSA, HSA Voluntary short-term and long-term disability insurance Voluntary life insurance 401K safe harbor plan and company match Paid vacation, holiday, and sick time Paid maternity & paternity leave What Sets Us Apart: WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs. We're Committed to Our Team: WEP has many initiatives to encourage wellness, growth and development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events, and all that we do to support our employees. We're Committed to DEI: At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth, embracing everyone's unique identities. Our services include: Access Programs Clinical Trial Services Patient Site Solutions Clinical Trial Supply Market Access and Commercialization WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment. WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law. Apply tot his job Apply tot his job