Clinical Trial Associate II

Premier Research is looking for a Clinical Trial Associate II to join our Clinical Monitoring, Site Management and SSU team.

You will help biotech, medtech, and specialty pharma companies transform life-changing ideas and breakthrough science into new medicines, devices, and diagnostics. What we do is profoundly connected to saving and improving lives, and we recognize our team members are the most valuable asset in delivering success.

• We are here to help you grow, to give you the skills and opportunities to excel at work with the flexibility and balance your life requires.

• Your ideas influence the way we work, and your voice matters here.

• As an essential part of our team, you help us deliver the medical innovation that patients are desperate for.

Join us and build your future here.

• Maintains Trial Master File (TMF)/electronic Trial Master File (eTMF) in collaboration with the clinical team as defined by the organizations or Sponsor’s SOPs and all applicable regulatory requirements.
• Creates and maintain placeholders in the TMF based on TMF filing plans, expired documents, study milestones, site staff changes, and other applicable events.
• Reviews site documents and verify they meet or exceed all company, sponsor, regulatory authority, and ALCOAC standards.
• Performs Quality Review and completeness checks of relevant eTMF sections in compliance with company or Sponsor processes throughout start up, maintenance, and close out activities and ensures follow up with clinical team of resolution of findings.
• Conducts follow up with the internal team on TMF queries to ensure timely resolution.
• Routinely runs and distributes eTMF reports to clinical team to facilitate quality and compliance.
• May assist SSUAs/CRAs with essential document collection and review during startup, maintenance and close out.
• May support the translation of site documents or reviews translations of site documents, if required.

What we are Looking for:

• Undergraduate degree required, or its international equivalent in nursing, life sciences or medical documentation from an accredited institution
• Minimum 1 - 2 year of prior experience as a Clinical Trial Associate or similar role. 
• An equivalent combination education and experience will be considered
• Fluent verbal and written English
• Working Knowledge of ICH/GCP, essential documents, and ALCOA+ principles
• Experience with clinical research systems, such as CTMS and eTMF ·
• Solid computer knowledge/skills including MS Word, Excel, PowerPoint and Outlook 
• Excellent interpersonal and listening skills 
• Solid organizational and time-management skills, demonstrated ability to meet deadlines 
• Ability to work independently as well as part of a team