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Senior Clinical Operations Lead
Location
Canada
Posted
13 days ago
Salary
$78K - $130K / year
Seniority
Senior
Job Description
Senior Clinical Operations Lead
Alimentiv
• 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 and the oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actions. • The COL will develop study tools for site and CRA use, review visit reports, review and track protocol deviations, and support other objectives for clinical operations and the clinical project team.
Job Requirements
- 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
- 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.
Benefits
- Health Sciences, Life Sciences or Nursing specialty preferred, or SoCRA and/or ACRP Certification/Designation.
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Title: Associate Director - Clinical Operations Location: Albany United States Job Category: Nursing Staff Requisition Number: ASSOC002512 Full-Time Hybrid Job Description: The Associate Director of Clinical Operations is responsible for the leadership, coordination, and execution of clinical operations for the College of Nursing and Health Sciences. Reporting to the Associate Dean, Academic Operations, this position supports the planning, development, and implementation of clinical operations to ensure high-quality, compliant, and scalable clinical and practice experiences for students. This role also provides oversight of State Board of Nursing operations, ensuring accurate, timely, and compliant licensure support services for students and graduates across all jurisdictions. The Associate Director supervises State Board staff and ensures alignment of licensure processes with institutional, regulatory, and student success goals. 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Essential Duties and Responsibilities, including but not limited to: Leadership and Operational Management - Lead the planning, development, and execution of clinical operations initiatives, ensuring timelines, deliverables, and outcomes are achieved. - Provide direct supervision, coaching, and performance management for clinical operations team, including hiring, training, assigning work, and evaluating performance. - Model operational best practices by actively engaging in team workflows and demonstrating effective process execution. - Ensure equitable workload distribution while maintaining the ability to independently perform team responsibilities. - Ensure continuity of operations by directly assuming responsibilities during staffing shortages, peak periods, or complex situations. - Provide direct oversight and supervision of the State Board team, including State Board Coordinators and related roles, ensuring high-quality, compliant licensure support services. - Establish performance expectations, monitor workload distribution, and ensure timely processing of licensure-related activities and student communications. - Ensure staff maintain current knowledge of evolving state-by-state licensure requirements and service protocols. 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