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Study Coordinator

Reference Number: 2541
Location: NJ

Our client is an international specialty clinical-stage biopharmaceutical company. They have asked us to assist them in their search for a Study Coordinator. 

In this role, the Study Coordinator will be responsible for providing high-level support in a fast-paced clinical trials environment assisting the Clinical Director and clinical trial team with various aspects of the study.  Under the supervision of the Director, the Coordinator will manage and document clinical activities, timelines, meetings, agendas, minutes and provide regular updates of the trial to team members.  

The Study Coordinator will:

  • Provide administrative support to the Director and team in all aspects of clinical trial coordination (Drug Supply, Regulatory, Data Management, Drug Safety…) 
  • Assure proper oversight of committees by the CRO and assist in the preparation and tracking of meeting minutes and documentation gathering for committees. 
  • Collect, synthesize and report high-level trial information to team members as requested 
  • Assist Director in creation and maintenance of project related documents (contracts, trial documents, reports, SOPs…) 
  • Coordinate and support study site visits by company personnel and vendor/site audit activities  
  • Prepare clinical conference presentations under the direction of presenter as needed 
  • Complete clerical tasks to assist Clinical Director and team in daily work (schedule meetings, arrange travel, expense reporting …) 
  • Create and maintain trial specific contact lists  
  • Provide administrative support to the Clinical Study Managers for filing SAEs, TMF filing, etc. as needed.   

We seek candidates with the following qualifications:

  • Bachelor’s degree preferred (but will consider Associates degree) and/or 2-4 years equivalent experience required.  
  • 2+ years experience supporting clinical trials in a pharmaceutical or biotech company or another CRO 
  • Medical/scientific writing skills preferred 
  • Ability to work independently, prioritize work, and handle simultaneous assignments under tight deadlines 
  • Demonstrated ability to develop complex reports, schedules, correspondence, and other administrative documents  
  • Experience handling sensitive and confidential business matters and information with discretion 
  • Ability to work collaboratively across organizations     
  • Strong computer skills to include Microsoft Word, Excel, Adobe Acrobat and PowerPoint  

Do you have the skills and experience we seek and want to advance your career with a growing, international company?  If so, please email your resume as a Word attachment along with your daytime contact information.