Sr. Clinical Trial Associate

Our Immunotherapy client located in Lexington, MA is looking to add a Sr. Clinical Trial Associate (CTA) to their team!  Role will independently provide clinical trial coordination support, along with implementation of clinical operational plans in accordance with regulatory guidelines and ICH/GCP standards. The Sr. CTA will be responsible for providing Clinical Operations support of study specific reports and site and vendor management activities. The Sr. CTA role may also support multiple clinical studies simultaneously.

Responsibilities (including, but not limited to):

  • Manage study-related vendors and serving as a point of contact for contracted CROs, study staff and contract labs; identifying potential risks and proactively resolving issues with CROs; establishing vendor management plans and reviewing quality metrics
  • Review monitoring reports, protocol deviations and data listings for studies
  • Coordinate cross-functional project-related activities (e.g., Clinical Data Review meetings)
  • Coordinate with CROs on site selection, IRB submissions, site initiation and close-out planning
  • Lead the development of reports for communicating study progress and key metrics to Senior Management and program team
  • Perform initial review of invoices against contracted services 
  • Assist with budget management
  • Prepare study timelines
  • Develop and manage study trackers and provide metrics as needed
  • Oversee site monitoring visits for clinical trials as needed
  • Ensure inspection readiness and provide support to sites to prepare for clinical audits/inspections
  • Prepare and maintain assigned program files
  • Ensure documentation is completed in accordance with GCP regulatory requirements and is consistent with the study protocols
  • Organize and prepare study files related to study tracking and reporting and submit to the Trial Master File within established guidelines

Requirements: 

  • Bachelor’s degree with at least 2 years of relevant work experience in a pharmaceutical, academic or CRO environment
  • Working knowledge of ICH/GCP regulations
  • Working knowledge of clinical protocols
  • Ability to accommodate a flexible work schedule according to clinical trial(s) priorities, as needed
  • Ability to work independently with minimal direction/oversight and within a team structure
  • Experienced with leading small group meetings and/or managing vendor relationships
  • Proficient in the use of Microsoft Office, advanced skills in Excel highly desirable