Clinical Trials Assistant


Provides support to the clinical study teams in the execution of clinical trials.  Primary responsibilities include maintaining Trial Master File (TMF) in an inspection-ready state, initiating collection, reviewing and tracking of essential documents throughout the life of the trial, initially the 140 triple-negative breast cancer(TNBC) study.  Contributes to the production and distribution of study materials and site/study communications.


  • Assist in conduct of clinical trials with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.
  • Assist the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for accuracy and completeness.
  • Assist with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.
  • Assist with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.
  • Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation.
  • May perform assigned administrative tasks to support team members with clinical trial execution.


  • Bachelor’s degree in life sciences or other field related to human study. An equivalent combination of education and applicable job experience may be considered.
  • Two (2) years’ experience in a combination of the following:
  • Excellent verbal and written communication skills.
  • Computer literacy mandatory with proficiency in Microsoft Word, Excel, Project and Outlook.
  • Coordination and planning of meetings, document management, people and time
  • management
  • Recognize potential obstacles and work to resolve them within set timelines
  • Conscientious and precise delivery of work even when under pressure
  • Able to manage multiple timelines and projects


  • Understanding relevant clinical operations activities
  • Ability to multi-task under limited direction and on own initiative
  • Ability to build and maintain positive relationships both internally and externally
  • Strong organizational, attention to detail and communication skills (written and verbal) in English
  • Computer proficiency in Microsoft Word, Excel, Project and Outlook.
  • Ability to learn and adapt new systems and processes
  • Ability to recognize potential obstacles and work to resolve them within set timelines
  • Conscientious and precise delivery of work even when under pressure


Has substantial understanding of the job and applies knowledge and skills to complete a wide range of tasks. Works on assignments that are moderately difficult, requiring judgment in resolving issues or in making recommendations. Normally receives little instruction on daily work, general instructions on newly introduced assignments.


While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk, or hear in a standard office environment. In a lab setting, occasionally use hands to finger, handle objects, tools, or controls. Employee must occasionally lift and/or move up to 20 pounds.


To apply, email your resume and cover letter to [email protected].  In the subject line of your email, please enter the exact name of the position for which you’re applying.