Clinical Trial Associate

2 weeks ago

Pennington, New Jersey, United States iPharm Full time
Key Responsibilities:
  • Support the Clinical Operations team in executing clinical trials, starting in the US and potentially expanding abroad
  • Manage and maintain the electronic Trial Master File for multiple US-based studies
  • Ensure proper access controls for trial documents
  • Develop systems for receiving, tracking, and archiving trial documents
  • Assist in start-up, maintenance, and close-out activities for investigation sites
  • Manage IRB submissions and archive approvals in the eTMF
  • Provide administrative support including drafting meeting agendas
  • Liaise with facilities, shipping vendors, and IT
  • Develop filing systems for non-TMF documentation
  • Participate in SOP development for trial procedures
  • Maintain databases for publication materials and sites
  • Conduct background research on investigators and vendors
Qualifications:
  • Understanding of Good Documentation Practice and ICH GCP compliance for Essential Documents
  • Knowledge of US regulatory requirements and SOPs
  • Proficient in Microsoft Office and Adobe Acrobat
  • Excellent organizational and communication skills
  • Fluent in English
  • Flexibility for international meetings
  • Ability to work independently
  • Physical ability to lift up to 25 lbs
  • Strong interpersonal skills
Education and Experience:
  • Minimum Associate's Degree, Bachelor's Degree preferred
  • 3+ years of experience as a clinical trial assistant or documentation specialist
  • Experience in the Pharmaceutical Industry or with a CRO
  • Proficiency in TMF maintenance and auditing
  • Experience managing Trial Master Files
  • Knowledge of electronic document management systems
  • Experience with Excel and data management
  • Archival and auditing experience
  • Meeting agenda and minute-taking experience
  • Training and SOP development experience
  • Calendar and investigational sites management
Travel:
  • Minimal travel involved
Work Environment:This is an office-based position located in Pennington, New Jersey with typical office activities and accommodations for disabilities

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