Contract - Clinical Trial Associate, Clinical Operations

Responsibilities

• Update and maintain clinical systems within project timelines and review files for accuracy and completeness
• Support the Clinical Operations team with ongoing conduct of studies including specific allocated study management tasks as defined by the Clinical Trial Manager (CTM)
• Prepare, handle and distribute of Clinical Trial materials and maintenance of tracking information
• Act as a central contact for the clinical team for designated project communications
• Schedule Project related meetings, attend operational team meetings, write and/or review meeting minutes, distribute minutes and follow-up actions
• Aid in preparation of meeting materials, presentations
• Absorb, handle, distribute, file and archive clinical documentation and reports according to standard operating procedures
• Aid in identification of potential clinical sites; maintain investigator lists
• Support organization of investigator meetings/advisory boards
• Review of study files periodically for accuracy and completeness
• Track and manage Case Report Forms (CRFs), queries and clinical data flow
• Utilize JDE system to monitor funds on existing purchase
• Manage tracking of all Clinical operations contracts generated (i.e. coding, approvals, filing, etc.) and associated invoices
• Other duties as assigned

  Requirements

  • BS/BA in Life Sciences preferred or demonstratable equivalent work experience
  • Minimum 1-year pharmaceutical industry experience in clinical development involved with Clinical Trials
  • Basic knowledge of applicable clinical research regulatory requirements including, Good Clinical Practices (GCP)
  • Basic knowledge of applicable protocol requirements
  • Experience with invoice review and processing

  Preferred Skills and Experience

  • Strong written and verbal communication skills
  • Strong Computer skills including proficiency in use of Microsoft Word, Excel
  • Effective time management and organizational skills
  • Self-starter, problem solver, self-motivated, actively seeks to increase responsibility
  • Attention to detail and accuracy in work
  • Strong customer service