Associate, Compliance & QA – IRB

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🕒 Julho 29

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WCG

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

🏥 Saúde

💊 Farmacêutico

☁️ SaaS

💰 Private Equity Round - WCG em 2019-11

Healthcare • Pharmaceuticals • SaaS

A WCG é uma empresa global de serviços e tecnologia para pesquisa clínica que apoia patrocinadores, CROs, centros de pesquisa e instituições durante todo o ciclo de vida dos ensaios clínicos. Fundada como líder em revisão ética independente, a WCG fornece revisão de IRB e IBC, comitês de monitoramento de dados, capacitação de sites e serviços de iniciação de estudos, recrutamento e retenção de participantes, e dados & insights (incluindo benchmarking, consultoria estatística e previsão de ensaios impulsionada por IA). A empresa também oferece um conjunto de plataformas tecnológicas (por exemplo, ClinSphere®, eReview Manager, Total Enrollment, Total Feasibility) e grandes conjuntos de dados de protocolos e desempenho para ajudar a projetar, planejar e conduzir ensaios de forma mais eficiente e em conformidade. A WCG se posiciona como parceira de organizações de biofarma e pesquisa médica para acelerar a ativação de ensaios, melhorar o recrutamento e garantir conformidade regulatória e ética.

Descrição

• 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.

🎯 Requisitos

• 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

🏖️ Benefícios

• 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