Associate, Compliance & QA – IRB

🕒 vor 2 Monaten

🇺🇸 Vereinigte Staaten – Remote

💵 $52.470 - $81.500 / Jahr

⏰ Vollzeit

🟢 Junior

🟡 Mittelstufe

🔧 QA-Ingenieur (Qualitätssicherung)

👻 Geisterscore 17%

Was es bedeutet: die Wahrscheinlichkeit, dass für diese Stelle niemand wirklich einstellt.So liest du es: 60 % oder höher heißt, wir halten das für einen Geisterjob. Niedrigere Werte sind weniger bedenklich.Wie wir werten: Dauer offen, Neuveröffentlichungen, offene Stellen vs Teamgröße, wie schnell Stellen geschlossen werden, und ob ein Gehalt angegeben ist.Hinweis: eine Schätzung aus öffentlichen Daten, kein Urteil über das Unternehmen. Echte Stellen können hoch punkten, nutze es also als Hinweis, nicht als Fakt.

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WCG

WebsiteLinkedInAlle Stellen

1001 - 5000 Mitarbeiter

🏥 Gesundheitswesen

💊 Pharmazie

☁️ SaaS

💰 Private Equity Round - WCG im 2019-11

Healthcare • Pharmaceuticals • SaaS

WCG ist ein globales Unternehmen für klinische Forschungsdienstleistungen und -technologie, das Sponsoren, CROs, Forschungsstellen und Institutionen während des gesamten Lebenszyklus klinischer Studien unterstützt. Gegründet als ein führendes Unternehmen im Bereich unabhängiger ethischer Prüfungen, bietet WCG IRB- und IBC-Prüfungen, Datenüberwachungskomitees, Standortaktivierung und Studienstartdienste, Teilnehmerrekrutierung und -bindung sowie Daten & Einblicke (einschließlich Benchmarking, Statistikberatung und KI-gestützte Studienvorausschau). Das Unternehmen bietet auch eine Reihe von Technologieplattformen (z. B. ClinSphere®, eReview Manager, Total Enrollment, Total Feasibility) und große Protokoll- und Leistungsdatensätze, um Studien effizienter und konformer zu gestalten, zu planen und durchzuführen. WCG positioniert sich als Partner für biopharmazeutische und medizinische Forschungsorganisationen, um die Aktivierung von Studien zu beschleunigen, die Rekrutierung zu verbessern und die regulatorische und ethische Compliance sicherzustellen.

Beschreibung

• 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

🎯 Anforderungen

• 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%

🏖️ Vorteile

• 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

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