Clinical Trial Associate
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Summary of Position
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.
Major Activities and Responsibilities
The Clinical Trial Associate is responsible for:
– 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
Requirements:
Qualifications and Background Requirements
– BS or BA required
– 1 – 2 years experience as CTA in a pharmaceutical or biotechnology setting; experience as a study coordinator may be considered
– Thorough knowledge of applicable regulatory rules and guidelines, e.g., ICH, GCP, SOPs
– 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%
