Lead Clinical Research Associate

Specific job duties

• Thorough knowledge of sponsor-specific project requirements, scope, protocol and timelines
• Provides oversight of the day-to-day clinical operations of US, European and/or multi-national global projects from start-up through close-out
• Reviews and approves monitoring reports and letters within UBC and/or sponsor timelines
• Leads and assists with UBC and project-specific training
• Ensures appropriate visit scheduling per protocol; tracks, reports and escalates adherence to site visit schedule, trip report metrics and documentation of completed tasks
• Provides oversight of the issues & actions and protocol deviations to ensure timely resolution per UBC and/or sponsor timelines
• Serves as primary liaison for monitoring issues, escalating to PM and/or Evidence Development Operations (EDO) Manager when appropriate
• Assists with preparation and leading of sponsor, project team and UBC meetings
• Assists as back-up for PM and may be primary contact for UBC/sponsor interaction
• Collaborates with PM to provide input into resourcing, analyzing cost variances, out-of-scope management, and conducting revenue recognition as applicable
• Coordinates site assignments for team in conjunction with PM and EDO Manager
• Monitors clinical operations aspects of the project against the established plans, SOPs and KPIs ensuring compliance
• Assists PM with the creation and maintenance of project-specific documents
• Responsible for maintenance of audit-ready project systems (eTMF, CTMS, project-specific systems) as related to clinical operations
• Mentors and supports project team
• May include reviewing the preparation, submission and tracking of Competent Authority (CA), Central and Local Ethics Committee and other regulatory applications, as per country requirements
• May include oversight of contract negotiation activities with the sites as per country requirements
• May be required to perform site monitoring as needed
• May review and provide oversight of study feasibility assessments
• May assist PM and EDO Manager with management of Vendor CRAs
• May require up to 30% travel
• Assists with other duties as assigned

Desired Skills and Qualifications

• Bachelor's degree in Health Care/Life Science preferred or equivalent industry experience
• Minimum of 5+ years of site management experience required with preference of 2 years field monitoring experience
• Knowledge and understanding of the local country laws applicable to clinical trials and observational studies
• Proficient in the operational methodologies of clinical trials and observational studies
• Thorough knowledge of medical terminology, ICH/GCP and UBC SOPs
• Excellent written and verbal communication skills in English and local language
• High attention to detail
• Excellent critical thinking and resolution skills
• Displays leadership, organizational, communication, time management and interpersonal skills
• Proven skills with CTMS, eTMF, EDC, Microsoft Office, basic computer software and sponsor specific systems
• Ability to work independently and within a cross-team environment
• Confident in taking responsibility for operational day-to-day project oversight
• Ability to coordinate monitoring project activities at local, national, and international studies