Clinical Trial Associate

Our client, a global biotechnology organization are expanding their clinical operations team and are currently recruiting for a Clinical Trial Associate to join their team on a permanent basis.
As a Clinical Trial Associate you will be responsible for assisting with setting-up and maintaining clinical documents and assist the Clinical Trial Manager on one or more trials in all relevant aspects of trial preparation, trial conduct, documentation and archiving.

Responsibilities:

• Support the clinical operations team with all aspects from study start-up, maintenance and close-out
• Support ongoing updates of the trial dashboard, trial budget maintenance and development
• Collection of all essential documents from investigator sites and functional areas and assist in TMF submission of essential documents
• Provide study essential document tracker or review of CRO tracker to ensure completeness
• Manage internal study meetings inclusive of setting agendas, recording and distributing minutes
• Review of plans and documents for clinical trials
• Provide sites with site binders
• TMF periodic review for trials
• Assist in TMF Preparation for internal audits and regulatory inspections
• Assist with clinical trial agreement submissions to legal for specific trials as well as other documents that will need legal review and track accordingly
• Assist with other documents, as needed, in support of the clinical trial

• Bachelor’s degree with a preferred focus on a life science or healthcare related field
• Clinical trial experience, with 2+ years of industry experience supporting clinical studies at a CRO or pharmaceutical company
• 1+ years of experience working directly for a sponsor
• Professional, proactive demeanor
• Strong interpersonal skills
• Excellent written and verbal communication skills
• Proficient in Microsoft Office