Clinical Trial Associate

  • Location:Cambridge,MA
  • Department:
  • Type:Full Time
  • Min. Experience:Entry Level

Clinical Trial Associate

 

RESPONSIBILITIES:

  • Key Support role to Clinical Operations
  • Assist in the development of study plans, informed consent forms, clinical trial tools and templates, and trial newsletters
  • Liaise with Clinical Development, Translational Science, and Clinical Pharmacology to develop and oversee study sample definition, kit development, shipping/collection, tracking, reconciliation, and analysis
  • Support the clinical trial/clinical operations lead in the setup, maintenance/oversight, audits, and close out of the Trial Master File (TMF)
  • Maintain and ensure study documentation is in a state of audit readiness
  • Provide support with tracking of invoices, coordination of contracts and budgets, maintaining timelines, vendor oversight, and site management
  • Assist with coordination of clinical trial equipment and clinical supply orders, logistics, and the drug release/approval process
  • Depending on experience, may take on activities to oversee CRO monitoring to ensure adherence to monitoring plans and quality metrics
  • Provide administrative assistance to the clinical operations team such as scheduling meetings, distributing agendas, taking minutes, and assisting with travel arrangements
  • Gain a strong understanding of and adhere to ICH-GCP, applicable regulatory guidelines, and company processes and SOPs
  • Learn best practices in clinical operations methodologies and systems with particular emphasis on quality, time, SOPs, and expectations
  • Actively participate in cross-functional initiatives including the development and updating of standardized clinical trial tools, processes, and SOPs
  • Work independently on tasks and know when to involve/collaborate with others
  • Position may require some travel (~5%)

 

EDUCATION AND EXPERIENCE: 

  • BS in scientific discipline with at least 2 years of relevant experience in a hospital, CRO, or bio/pharmaceutical company
  • Ability to multi-task and work in a fast-paced environment
  • Collaborative team player who works well cross-functionally
  • Demonstrates knowledge and understanding of ICH Guidelines and GCPs governing the conduct of clinical trials
  • Strong verbal, written, presentation and computer skills, including knowledge of Microsoft Excel, Word, PowerPoint and Outlook; Microsoft Project/equivalent helpful
  • Independent strategic problem solver who thinks actions all the way through, knows when and is not afraid to seek help, and is able to adapt in a changing and fast-paced environment