Clinical Trial Associate

Company: Precision for Medicine
Location: Norton
Posted on: September 23, 2022

Job Description:

Position Summary:

The Clinical Trial Associate will provide support to the Clinical Operations and Project Manager through the performance of project-specific tasks whereby contributing to the overall management of clinical trials.

Essential functions of the job include but are not limited to:

• Assist clinical study and project management teams with all aspects of study site management from study start-up to close-out on various studies simultaneously
• Assist with preparations of essential document templates, binders, collection, and review. Perform study tracking to ensure study files are current, accurate and complete
• Create and maintain central study files, including the electronic trial master file (eTMF) or TMF, for the duration of the study including assisting in file review and reconciliation for audits, in addition to preparing study files for archival
• Assist in planning, organizing and executing project-specific meetings including but not limited to Precision-Client meetings, Site-Precision meetings, and PI meetings
• May be responsible for collection kit/supply assembly, tracking and shipping
• Prepares correspondence, spreadsheets and presentations utilizing Microsoft Office Suite, for project specific studies. Develop and maintain project specific plans, documents and tools for the Clinical Team
• Take initiative to support the Clinical Operations team to ensure timely, successful activation of trial sites according to time, quality/scope and budget parameters
• Collaborate with the Project Manager (PM) to facilitate cross-functional team and Client communications for proactive, study-wide problem solving regarding study progress and trial issues during the study
• Liaise with Internal and External customers/vendors to meet project specific goals and Client deliverables
• Support Clinical Team Manager/Lead in the management of investigational sites to ensure compliance with the trial protocol, ICH-GCP and applicable regulations, as required by certain projects
• Performs all duties in accordance with Precision's SOPs, government regulations and Good Clinical Practices (GCP) and Good Documentation Practices (GDP)
• Carry out other duties/projects as assigned
  
  Qualifications:
  
  Minimum Required:
  
  • Bachelor's degree in a clinical, scientific, or related field
  • Minimum of 2 years related experience, or equivalent combination of education and apprenticeship
    
    Other Required:
    
    • Experience with Microsoft Office Products (Outlook, Word, Excel, PowerPoint)
    • Able to read and interpret documents such as safety rules, operating and maintenance instructions and procedure manuals; to write routine reports and correspondence; to speak effectively before groups of customers or employees of organization
    • Must possess a customer service demeanor; demonstrate flexibility, teamwork, and a keen attention to detail
    • Understands clinical trials methodology, including a working knowledge of protocols and indications being studied
    • Demonstrates knowledge of ICH-GCP, and regulatory guidance, as well as the ability to implement
    • Resolves project related problems and prioritize workload to meet deadlines with little support from management
    • Exhibits high self-motivation, and is able to work and plan independently as well as in a team environment
    • Demonstrates an acceptable degree of professionalism, as evidenced by punctuality, ability to deliver on commitments, an understanding of the service culture and positive interactions with customers and teammates, including good interpersonal skills
    • Excellent communication skills (verbal and written) and collaborative working style Possesses practical knowledge of IT tools and systems in use on project team, particularly the MS Office suite, version 2010 or more recent
    • Ability to fulfill the clinical operations and data management roles with Precision Biospecimen Solutions
    • Must be able to read, write, speak fluently and comprehend the English language
      
      Preferred:
      
      • Continuing education courses toward Master's Degree in a clinical, scientific, or related field preferred
        
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Keywords: Precision for Medicine, Brockton , Clinical Trial Associate, Healthcare , Norton, Massachusetts