Clinical Operations Assistant

Job description

As Clinical Operations Assistant, you will assist/support the clinical operations teams in study-related administrative activities such as but not limited to:

• Construction of various study-related forms/templates
• Creation and mailing of study-related webforms (e.g. study-specific questionnaires)
• Dispatching of incoming study-related correspondence, internal documentation, etc., as appropriate
• Sending of study-related documentation to sites
• Follow-up, collection and filing of country- and site-specific documents required for site activation following GCP standards
• Report on a regular basis on document collection status during the site activation phase
• Coordination of study drug and sample kits supplies to the sites, as appropriate
• Maintenance of tracking tools (document collection status, sample tools,…) applicable to the study
• Set-up, organization and maintenance of clinical study documentation (e.g. study files, etc.) including preparation for internal/external audits, final reconciliation and archival
• Set-up of study-specific meetings (phone conference, face to face, webex,…)
• Management of CTEP registrations of investigators participating in US-lead studies

Profile

The COA is a challenging position for a person interested in the field of Cancer Clinical Trial operations. 

• Bachelor in Life Sciences with preferably one year experience in a similar function
• Excellent team player
• Good organizational skills, ability to work independly, manage multiple tasks and competing priorities
• Meticulous, attention to details
• Good communication skills
• Computer literate with Microsoft Word, Excel, PowerPoint, Outlook
• GCP certification is an asset
• Excellent written and spoken English