Sr. Clinical Operations Lead

3 semanas atrás


Belém, Brasil Alimentiv Tempo inteiro

2 weeks ago Be among the first 25 applicants

Overview shows responsibility for clinical operations of a project at regional/global level, with oversight of project deliverables, CRAs, and Investigator sites in line with the Monitoring Plan, Protocol, GCP, ICH guidelines and local regulations. The COL acts as primary liaison between CRAs and the clinical project team. Additional responsibilities include project-specific training of CRAs, assessment visits with CRAs, implementing enrollment and recruitment strategies, preparing monitoring plans and other documentation, and overseeing monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions. The COL develops study tools for site/CRA use, reviews visit reports, tracks protocol deviations, and supports other clinical operations objectives.

Responsibilities
  • Overall oversight of regional CRAs to ensure site compliance with study protocol, study plans, ICH-GCP, local regulations, and study timelines.
  • Monitoring support visits (co-monitoring) to aid site/CRA in satisfactory performance and compliance with standards.
  • Provide oversight of study deliverables related to other departments (e.g., Data Management, TMF Operations) as required.
  • Oversee regional startup and feasibility activities.
  • Assist in vendor management activities as required per project.
  • Review visit reports for quality, compliance, and site management.
  • Ensure compliance with high-quality and timely project deliverables per project requirements and the monitoring plan.
  • Proactively manage site and country performance (recruitment, data collection, document collection, TMF review) and inform the clinical project team on progress.
  • Contribute to financial project management processes as applicable (e.g., revenue recognition, site payments, site pass-through expense review).
  • May 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, and with individual/country CRAs.
  • Provide status updates on country and site progress to Study Sponsor meetings.)
  • Provide operational support and guidance to the monitoring team throughout the project.
  • Provide project training/mentoring to regional CRAs on study procedures, plans, guidelines, and timelines; ensure required training is completed and documented.
  • Serve as first point of contact for regional CRAs for study-specific questions and issues; escalate to PM and other functions as appropriate.
  • Support line managers with status updates on CRA utilization and performance.
  • Coordinate with line manager to assign sites to CRAs following CRA resource allocation to the project.
  • Conduct CRA Assessment visits to assess performance against 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 with the clinical project team.
  • Develop presentation materials for Sponsor Kickoff meetings, Investigator meetings, and Sponsor Calls, and prepare presentations for Site Qualification Visits and Site Initiation Visits.
Qualifications
  • College diploma/degree AND 7-9 years related experience with ongoing training and skills upgrading
  • OR undergraduate university degree (Bachelor’s) AND 4-6 years' experience with substantial ongoing job-related training
Other
  • 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.
  • Strong understanding of GCPs and local regulations as they relate to clinical monitoring, IRB/EC, and Investigator responsibilities.
  • Demonstrated ability in report writing and critical understanding of clinical research documents.
  • Ability to handle multiple tasks to meet deadlines in a dynamic environment.
Working Conditions
  • Home-based
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