[Hiring] Senior Clinical Operations Lead @Alimentiv

Role Description

Responsible for the clinical operations of a project within a defined regional/global level. Provides oversight of project deliverables, assigned Clinical Research Associate (CRAs) and Investigator sites in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and local regulations. The COL acts as a primary liaison between the CRAs and the clinical project team. Additional responsibilities include:

• Project specific training of CRAs
• Conducting assessment visits with CRAs
• Implementation of enrollment and recruitment strategies
• Preparation of the monitoring plan and other structural documentation
• Oversight of monitoring visit scheduling
• Site and monitoring performance metrics
• Issue escalation and corrective actions
• Developing study tools for site and CRA use
• Reviewing visit reports
• Reviewing and tracking protocol deviations
• Supporting other objectives for clinical operations and the clinical project team

Qualifications

• College diploma/degree AND 7-9 years related experience + continuous training and knowledge/skills upgrading
• OR Undergraduate university degree (Bachelors or Honors Bachelors) AND 4-6 years' experience + substantial on-going job-related training
• Health Sciences, Life Sciences or Nursing specialty preferred, or SoCRA and/or ACRP Certification/Designation
• Minimum of 3 years CRA experience
• Strong experience with EDC systems
• Proficient with MS Office
• Strong written and verbal communication skills
• Highly effective interpersonal and organizational skills
• Proactive, detail oriented, task-driven and highly organized
• Demonstrated understanding of GCPs and local regulations as they relate to clinical monitoring, IRB/EC and Investigator responsibilities
• Ability in report writing and understanding clinical research documents
• Ability to handle multiple tasks to meet deadlines in a dynamic environment

Requirements

• Overall oversight of (a group of) regional CRAs to ensure (site) compliance with study protocol, study plans, ICH-GCP, local regulations and study timelines
• Monitoring support visits (Co-monitoring), per project requirements
• Support clinical project team by providing oversight of study deliverables related to other departments (e.g. Data Management, TMF Operations, etc.)
• Oversee regional startup and feasibility activities
• Assist in vendor management activities as required per project
• Perform review of visit reports for quality, compliance and appropriate site management
• Assure compliance with high quality and timely project deliverables according to the project requirements and the monitoring plan
• Proactive management of site and country performance (recruitment, data collection, document collection, TMF review etc.)
• Contribute to financial project management processes as applicable
• Manage/oversee investigator sites including CRA responsibilities, on a temporary or permanent basis
• Conduct regular global CRA calls with the monitoring and site management team
• Attend meetings with Study Sponsor to provide status updates on country and site progress
• Provide operational support and guidance to the monitoring team throughout project
• Provide project training/mentoring to regional CRAs on study procedures, clinical plans and guidelines, and timelines for the study
• First point of contact for regional CRAs for study-specific questions and issues
• Support line managers by providing status updates on utilization and performance of CRAs
• Liaise with line manager for assigning sites to CRAs
• Conduct CRA Assessment visits per departmental requirements

Benefits

• Home-based
• $86,000 - $143,000 a year + Bonus
• Accommodations for persons with disabilities are available on request