Clinical Trial Associate (Contract) | BioNJ Talent Services

Clinical Trial Associate (Contract)

Contact Information
Contact Name: 
Amicus Therapeutics
Organization Name: 
Amicus Therapeutics
Position Location: 
Cranbury
Company Profile: 

Amicus Therapeutics, Inc. (Nasdaq:FOLD) is a global biotechnology company at the forefront of advanced therapies to treat a range of devastating rare and orphan diseases. We have a robust development pipeline of treatments for a range of human genetic diseases.

Our lead product candidate, migalastat, is a personalized medicine in late-stage development to treat individuals with Fabry disease on the basis of their genetic diagnosis. SD-101, a product candidate in late-stage development, is a potential first-to-market therapy for the rare genetic connective tissue disorder Epidermolysis Bullosa (EB). We are leveraging our biologics and Chaperone-Advanced Replacement Therapy (CHART™) platform technologies to develop novel enzyme replacement therapy (ERT) products for Fabry disease, Pompe disease, and other Lysosomal Storage Disorders (LSDs). Our lead biologics program is ATB200/AT2221, a uniquely engineered Pompe disease ERT that will be administered in combination with a pharmacological chaperone.

Job Description:

Position Summary

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

Qualifications: 

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
Excellent verbal and written skills and have the ability to deal effectively with all levels of management.
Solid grasp of MS Powerpoint, Word, Excel and Project
Can locate information quickly and resourcefully
Self-motivated and able to function with little supervision
Highly detail-oriented
Excellent interpersonal skills
Superior communication skills, both verbal and written
Good team player
Able to resolve conflicts in a diplomatic manner

Travel
0-5%

Additional Job or Internship Information
Position Type: 
Contract
Function: 
Clinical Operations