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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
Job Description

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