Clinical Program Coordinator

Twitter Facebook
Cambridge, MA
$1.00 - $1.00
Job Type
Jul 10, 2018
Job ID
Clinical/Sr. Clinical Program Coordinator (Contract)
The Clinical/Sr. Clinical Program Coordinator is responsible for supporting the clinical development operations team across multiple clinical studies and programs, as well as clinical development operations department-wide activities and initiatives.
 Study team and department support 
    • QC study documents
    • Coordinate sponsor team review and finalization of key study documents
    • Support study team during key deliverable milestones
    • Meeting logistics, documentation, and follow-up
    • Support financial management activities
    • Develop trackers and presentations for department in support of key projects, i.e. stakeholder communications  
  • Document management / TMF SME and support (Department and study / program level)
    • Department, Program and Study Level:
      • SME for study document management
      • Lead implementation of eArchive, including related process development
      • Evaluate, develop and maintain TMF process documentation including creation of TMF Review Plans, review of study and program indexes, development of tools for documenting Sponsor TMF review / oversight
      • Coordinate and conduct TMF reviews with study personnel according to TMF Plans
      • Liaise with CRO TMF personnel and eArchive vendor
      • Communicate TMF-related updates and issues to clinical operations leads and work with vendors to address findings through resolution / closure
      • Load documentation to share folder / eArchive
      • Ensure complete and inspection ready eTMFs throughout the duration of clinical trials
  • Vendor, contract and budget support 
    • Assist contract manager and study / program operations leads in tracking contract spend and values
    • Vendor communications; may also assume direct vendor management
    • Support vendor selection and ongoing vendor performance evaluations
  • At least 5 years of experience supporting clinical trials administratively or as a study coordinator; experience with a pharmaceutical or biotech company is preferred; additional experience in other related fields or positions is a plus.
  • BA/BS in a clinical or scientific discipline preferred; can be substituted with more years of experience.
  • Savvy with IT systems including standard MS software applications.
  • Good general GCP knowledge.
  • Excellent interpersonal, organization, problem solving, and communication skills.
  • Working collaboratively and proactively with a “can-do” attitude.