Clinical Trial Associate
Location: Cambridge, Massachusetts, USA
GENFIT is a biopharmaceutical company focused on discovering and developing drug candidates and diagnostic solutions targeting liver diseases, in particular those of metabolic origin, and hepatobiliary diseases, where there is still considerable unmet need.
As a Clinical Trial Associate, you will be responsible for supporting Clinical Development activities.
This position is located in our Cambridge (USA, MA) office.
Your responsibilities include, but are not limited to:
› Assisting the Clinical Operations Team in the preparation, handling, distribution, filing, archiving, and tracking of clinical documentation and reports
› Accurately organizing the electronic trial master file (eTMF): filing essential documents in the study eTMF, verifying the quality of the documents and preparing periodic completeness reports
› Maintaining internal trackers for clinical trial activities and study documents
› Serving as a Clinical Operations administrative point of contact for internal stakeholders and external vendors (including Contract Research Organizations)
› Using various vendor systems to provide metrics and administrative support as needed
› Participating in the development of internal processes and procedures regarding the TMF
› Representing the Clinical Operations Team for designated project communications, correspondence and associated documentation
› Organizing and participating in internal team meetings, including drafting agendas and minutes
o Computer skills including proficiency in use of Microsoft Word, Excel, PowerPoint, and clinical trial management systems (Veeva Vault eTMF preferred)
o Knowledge of ICH, GCP
o Strong written and verbal communication skills including good command of English language; French language is a plus
o Effective time management and organizational skills
o Attention to detail and accuracy in work
o Ability to establish and maintain effective working relationships with coworkers, managers, and external vendors
› Job Type: Full-time
› Experience: 2 years in Clinical Operations
› Education: Bachelor’s degree
› Required work authorization: United States
Interested candidates should submit their resume and cover letter to Aude Jacheet at: firstname.lastname@example.org.