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- Clinical Trial Associate
- Clinical Trial Management
- Clinical Trial Quality Assurance Associate
- Lead Clinical Trial Associate
- Clinical Trial Management Associate
- Clinical Trial Payments Associate
- Senior Clinical Trial Associate
- Remote Clinical Trial Disclosure Associate
- Trial Associate
- Global Clinical Trial Associate
Clinical Trial Associate Jobs
Company | NuWest Group |
Address | United States |
Employment type | CONTRACTOR |
Salary | |
Category | Biotechnology Research |
Expires | 2023-07-16 |
Posted at | 10 months ago |
We are hiring a Clinical Trials Associate who will be a key member of the clinical team. You will support operational project delivery for a portfolio of cell and gene therapy programs.
What you'll do
• In collaboration with Clinical Operations Team, support the study operational strategies
• Track trial progress towards planned milestones, as well as related progress analysis and follow-up
• Lead assigned project tasks and see these tasks through to completion, with guidance
• Develop meeting agendas, minutes and track follow-up actions
• Ensure eTMF oversight including routine quality checks to maintain a complete and inspection-ready state
• Maintain a vendor and site contact list
• Work with the clinical operations team to prepare metrics and updates for management
• Help with budget monitoring including invoice review, and confirmation of site payments
• Assist clinical sites with questions and resolving queries, as needed
• With oversight from the Clinical Operations Lead, provide support to the multifunctional team on special projects as needed
• Participate in QA Audits, as needed
• Create and improve upon business processes to ensure Sana's successful growth, with guidance
• Maintain a professional relationships with internal and external study teams and stakeholders
What we're looking for
• Bachelors (preferably in a Life Science or Business discipline) or equivalent
• 2+ years of experience in a clinical operations role in the biopharmaceutical industry
• Understanding of ICH GCP compliance
• Excellent communication, time management and organizational skills
• Experience planning and tracking deliverables and timelines
• Ability to quickly learn and work with new technologies and IT solutions
• Take ownership of assigned responsibilities, with guidance
• Ability to work well in a dynamic environment and to prioritize and respond to changing needs of the business
• Proficiency in Microsoft Office applications
• Ability to travel as required
What will separate you from the crowd
• Specific experience in Lymphoma or CAR T trials
• Experience with TMF and eTMF Systems
• Experience with EDC and other technology
What you should know
• Occasional travel to office sites and site/vendor locations will be required
• Opportunity for growth and added responsibility
• Working safely in person on a predictable and regular in-person basis is an essential job function for this position, and the Company requires that all individuals working in-person be fully vaccinated against COVID-19, including receipt of a vaccine booster shot if recommended by the CDC
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