Clinical Operations Lead

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Alimentiv

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Clinical Trials Design • Planning • Safety Management • Custom Services • Study Management

201 - 500 employees

Founded 2020

⚕️ Healthcare Insurance

🔬 Science

💊 Pharmaceuticals

Description

• 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. • Acts as a primary liaison between the CRAs and the clinical project team. • Includes project specific training of CRAs, conducting assessment visits, and implementation of enrollment and recruitment strategies. • Preparation of the monitoring plan and other structural documentation. • Oversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation, and corrective actions. • Develop study tools for site and CRA use, review visit reports, track protocol deviations.

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 • 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 • 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

+ Bonus