Position Description

Clinical Trial Associate
Location US-Cranbury, NJ
Requisition ID 1559
# of openings 1
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Summary of Position

Amicus Therapeutics is a global, patient-dedicated biotechnology company focused on discovering, developing and delivering high-quality medicines for people living with rare metabolic diseases.

The Clinical Trial Associate is responsible for assisting the Clinical Operations team(s) to provide efficient execution of assigned studies, including appropriate filing of all documentation.


Roles and Responsibilities 

  • Assist with documents during study start-up including CDAs and CTAs
  • Assist with compilation of regulatory documents
  • Track incoming and outgoing regulatory packages
  • Assist in organization of Investigators’ Meetings
  • Assist with patient tracking to document patient visits and overall study progress  
  • File essential documents and maintain the TMF  
  • Track CRFs     
  • Coordinate investigator payments for studies where the Sponsor is responsible for this activity. Verify investigator payment details submitted for payment by CROs for studies where CROs are responsible for this activity 
  • Support Clinical Project Manager / Associate Director with meetings, including preparation of agendas and minutes and tracking action items
  • Distribute trial-related materials to study sites  
  • Support preparation and subsequent distribution of newsletters  
  • Prepare Study File Notebook for review by study team  
  • Create and maintain tracking tools to monitor collection and expiry of essential documents; work with CRO team to obtain required updates 
  • Create and maintain the Trial Master File and electronic workspace (SharePoint) for each study and the program. Ensure that all essential study documents are tracked and filed in a timely manner 
  • Prepare, distribute, file, and archive clinical documentation and reports 
  • Review study files/TMF periodically for accuracy and completeness 
  • Review site regulatory and essential documents to approve initial drug shipment 
  • Assist with essential document reconciliation at study end 

Organizational Structure

  • Reports to Clinical Trial Manager, Clinical Operations

Qualifications and Background Requirements

  • BS or BA required
  • Demonstrated experience (at least one year) in clinical trial operations involving multiple projects involving cross functional, multi-site, teams. Well organized and capable of managing multiple tasks with respect to priorities< >xcellent verbal and written skills and have the ability to function in a collaborative environment with members of other teams (regulatory, data management, quality assurance, etc.)
  • Self-motivated and able to function with little supervision
  • Solid grasp of MS Word, Excel, PowerPoint and Project

Compensation

  • A competitive compensation package will be presented to the right individual including base salary, bonus, and equity or indicated in the Employment Contract.

Location

  • This position will be based at 1 Cedar Brook Drive, Cranbury, NJ, 08512 or as indicated in the Employment Contract
  • Travel 0 to 5 %
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