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

• OR
  • College diploma/degree AND 7-9 years related experience +continuous training and knowledge/skills upgrading
  • 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