Clinical Operations Lead

Project Oversight

• 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, to aid the site/CRA in the satisfactory performance and compliance with standards mentioned above.
• May 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.) and inform clinical project team on progress.
• Contribute to financial project management processes as applicable. May include but may not be limited to input on revenue recognition, site payments, and site pass-through expense review.
• May be required to manage/oversee investigator sites including CRA responsibilities, on a temporary or permanent basis.

Project Liaison

• Conduct regular global CRA calls with the monitoring and site management team, as well as individual/country CRA calls
• 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. Ensures study specific training requirements are completed and documented.
• First point of contact for regional CRAs for study-specific questions and issues. Escalates to PM and other functions as appropriate.
• Support line managers by providing status updates on utilization and performance of CRAs.
• Liaise with line manager for assigning sites to CRAs following line manager allocation of a CRA resource to the project.
• Conduct CRA Assessment visits per departmental requirements to assess the performance of the CRA against their monitoring responsibilities.

Study Documents and Plans

• Develop training materials and study tools for sites and CRAs, including monitoring plans.
• Develop and implement enrolment and recruitment strategies together with clinical project team.
• Develop presentation materials for and presents at Sponsor Kickoff meetings, Investigator meetings and Sponsor Calls (as needed), and prepares presentations for Site Qualification Visits and Site Initiation Visits.

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

Other

• Health Sciences, Life Sciences or Nursing specialty preferred, or SoCRA and/or ACRP Certification/Designation.
• Should have a minimum of 3 years CRA experience, have strong experience with EDC systems, be proficient with MS Office, have strong written and verbal communication skills and highly effective interpersonal and organizational skills.
• Demonstrate the following attributes: proactive, detail oriented, task-driven and highly organized.
• Demonstrate the critical elements of GCPs and local regulations as they relate to clinical monitoring, IRB/EC and Investigator responsibilities.
• Demonstrated ability in report writing and strong ability to critically understand clinical research documents.
• Ability to handle multiple tasks to meet deadlines in a dynamic environment.

Working Conditions

• Home-based