Clinical Trial Assistant
ReSearch Pharmaceutical Services - Cambridge, MA

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The successful candidate will provide a wide range of administrative support to the Clinical and Regulatory functions. Provide back-up administrative support to other company administrative professionals to ensure a team approach to company needs.

Responsibilities include (but are not limited to) :
  • Organize logistics (including travel arrangements) and prepare materials for Investigator and Clinical Team meetings
  • Copy, collate, prepare and ship clinical study binders for clinical sites
  • Prepare and ship supplies and documents to support clinical studies
  • Organize payment system and ensure timely payments to clinical sites and other vendors
  • Working closely with in-house clinical trial managers (CTMs)
  • Track distribution of investigational drug supply
  • Format, prepare, and coordinate translations of study documentation
  • Manage the administrative affairs of the department, including invoice processing, expense reports and departmental expenses, supply procurement, including review of expenses to consider cost saving opportunities.
  • Format documents for regulatory submissions
  • Prepare large regulatory submissions, including copying, collating, binding, QC submissions to FDA
  • Maintain hard copy and electronic regulatory files
  • Maintain supplies
  • Provide backup administrative support to other administrative assistants and company executives.
  • Ensure administrative professionals are working together as a team to meet company administrative needs.
  • Shows strong initiative; positive, outgoing and upbeat attitude
  • Ability to multi-task and work well under pressure with a calm demeanor, excellent organizational skills and ability to follow-through- ensuring no items are overlooked.
  • Ability to exercise sound decision-making and good judgment
  • Manage and prioritize multiple projects in a timely manner and meet deadlines
  • Outstanding organizational, written and communication skills
  • Demonstrate a high level of professionalism and able to work with many levels of management
  • Effective organizational, project management, time management and event planning skills
  • Must have a professional and respectful demeanor when interacting with internal or external customers, consultants and vendors
Qualifications :
  • BA/BS degree preferred
  • Proven ability to use Microsoft Office Suite applications including Word, Excel, Outlook calendar and email, and PowerPoint; experience with presentation graphics helpful.
  • Experience in the pharmaceutical or biotech industry
  • Strong attention to detail