Clinical Operations Administrative Support

About the role

Join our Clinical Operations team and help support the successful delivery of global clinical trials. As a Clinical Operations Administrative Support (COAS), you will provide administrative and operational support to clinical trial project teams, ensuring studies are conducted efficiently, documentation is maintained accurately, and clinical sites receive the support they need throughout the trial lifecycle.

Responsibilities

• Exchanges project-specific information and documents with other PSI departments, sites and vendors
• Maintains information in study-specific and corporate tracking systems
• Supports regulatory and ethics committee submissions and notifications
• Affords support to internal team meetings
• Coordinates sites payments within the project team
• Prepares draft agendas for, and minutes of, internal team meetings
• Affords assistance with preparation, conduct and follow-up of Investigator Meetings
• Affords assistance with clinical supplies order, receipt, inventory storage, distribution, return/recall and reconciliation at either PSI warehouse or as defined by the project team
• Affords assistance with translations of study-specific documents
• Maintains, performs regular periodic checks of, and files study related documents in the TMF on a site and country level
• Prepares, distributes, and updates Investigator Site Files (ISF) and ISF checklists
• Affords assistance with safety information flow with investigative sites
• Performs other departmental assignments, as necessary

Requirements

College or university science degree or an equivalent combination of education, training and experience that presents the required knowledge, skills and abilities is considered sufficient. Equivalency is defined as a minimum of 1 year experience in corporate or academic environment where administrative experience and technical skills have been gained. Strong organizational skills with exceptional attention to detail. Ability to manage multiple priorities and work effectively in a fast-paced environment. Excellent written and verbal communication skills. Proficiency with Microsoft Office applications.