Job Title: Clinical Operations Lead
Location: (Remote)
Department: Clinical Services – Clinical Operations - Monitoring & Site Management
Employment Type: Full-time, Permanent
Accommodations: Available upon request throughout the recruitment process
Reports To: Clinical Project Team
Job Summary:
The Clinical Operations Lead (COL) is responsible for the clinical operations of a project within a defined regional/global level. The COL provides oversight of project deliverables, assigned Clinical Research Associates (CRAs), and investigator sites in accordance with the Monitoring Plan, protocol, Good Clinical Practice (GCP), ICH guidelines, and local regulations. This role acts as the primary liaison between CRAs and the clinical project team. The COL will also oversee monitoring visit scheduling, site performance metrics, and issue escalation and corrective actions.
Key Responsibilities:
Project Oversight
Provide oversight of regional CRAs to ensure site compliance with study protocol, ICH-GCP, local regulations, and study timelines.
Conduct co-monitoring visits to assist sites/CRAs in ensuring performance and compliance.
Support clinical project teams by overseeing study deliverables related to other departments (e.g., Data Management, TMF Operations).
Oversee regional startup and feasibility activities, and assist with vendor management.
Review visit reports for quality and compliance.
Ensure compliance with timely and high-quality project deliverables according to the monitoring plan.
Proactively manage site and country performance (e.g., recruitment, data collection, TMF review) and provide updates to the clinical project team.
Contribute to financial project management processes, including site payments and expense review.
May be required to manage or oversee investigator sites, including CRA responsibilities.
Project Liaison
Conduct regular global CRA calls and individual/country CRA calls.
Attend meetings with Study Sponsors to provide updates on site progress.
Provide operational support to the monitoring team throughout the project.
Provide project-specific training and mentoring to CRAs on study procedures, clinical plans, and timelines.
Act as the first point of contact for regional CRAs for study-related questions and issues.
Support line managers by providing updates on CRA performance and utilization.
Liaise with line manager for site allocation to CRAs.
Study Documents and Plans
Develop training materials and study tools for sites and CRAs, including monitoring plans.
Work with the clinical project team to implement enrollment and recruitment strategies.
Prepare presentation materials for Sponsor Kickoff meetings, Investigator meetings, and Sponsor Calls.
Develop presentations for Site Qualification and Site Initiation Visits.
Qualifications:
Educational Requirements:
College diploma/degree + 7-9 years of related experience and ongoing training.
OR Undergraduate degree (Bachelor's or Honors Bachelor's) + 4-6 years of experience and continuous job-related training.
Specialized Knowledge and Skills:
Health Sciences, Life Sciences, or Nursing specialty preferred.
SoCRA and/or ACRP Certification/Designation is preferred.
Minimum of 3 years CRA experience.
Strong experience with EDC systems.
Proficiency with MS Office.
Strong written and verbal communication skills.
Demonstrated ability to handle multiple tasks, meet deadlines, and maintain organization in a dynamic environment.
Attributes:
Proactive, detail-oriented, task-driven, and highly organized.
Ability to critically understand clinical research documents.
Ability to manage site and CRA performance and communicate effectively across teams.
Working Conditions:
Home-based position.
Accommodations for persons with disabilities are available upon request throughout the recruitment lifecycle.
How to Apply
Interested candidates should apply via the Alimentiv website.
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