Clinical Trial Associate

Job ID
2018-1123
Category
Clinical Operations
Job Location
US-MA-Cambridge

Company Summary

The successful candidate will assist with daily clinical trial execution activities and assist in the coordination of documentation associated with the conduct of investigational clinical studies in accordance with Food and Drug Administration (FDA) Regulations, Good Clinical Practice (GCP), and company standard operating policies and procedures.

Role / Responsibilities

RESPONSIBILITIES

  • Responsible for study laboratory sample management, including tracking and vendor management support
  • Collect trial information and disseminate it to the internal project team, the CRO, and other stakeholders
  • Schedule and coordinate study meetings, materials and agendas; recording and disseminating decisions and actions
  • Responsible for quality control of the eTMF including maintenance and oversight
  • Coordinate and manage version control of clinical documents.
  • Prepare distribution of copies of finalized protocol and study documents. Assemble investigator and pharmacy manuals
  • Assist in responding to Data Correction Forms (DCFs) and track DCF follow-up and completion activities.
  • Assist in the coordination and tracking of clinical supply shipments, including review and approval of Regulatory Documentation Packages
  • Assist in the creation and updating of standardized clinical trial tools, processes, and SOPs
  • Organize and maintain tracking systems and tools to support the conduct of a clinical study from start-up to close-out

Qualifications

REQUIREMENTS

  • BS/BA degree or equivalent and at least year experience in clinical operations in Sponsor company with 1+ years strongly preferred
  • Knowledge of drug development, clinical operation processes and documentation including study start up procedures, maintenance phase, and study close out procedures
  • Knowledge and implementation of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations is required
  • Experience with eTMF; ability to directly apply essential document knowledge to file documents
  • Strong communication, organizational and interpersonal/team skills
  • Proficient in MS Excel, Word and PowerPoint.  Knowledge of MS project preferred.
  • Established ability to prioritize and manage multiple tasks simultaneously, demonstrated ability to identify and resolve issues, and effectively manage timelines
  • Participate in inter-departmental workgroups to create or enhance processes
  • Strong customer service orientation
  • Strong attention to quality/detail

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