Clinical Operations Lead

September 20

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

201 - 500

Description

• Responsible for clinical operations oversight of a project • Provides oversight of project deliverables, assigned CRAs and Investigator sites • Acts as a primary liaison between CRAs and clinical project team • Conducts assessment visits with CRAs and implements strategies • Develops study tools and reviews visit reports and protocol deviations • Ensures compliance with high quality and timely project deliverables.

Requirements

• Fluent in the reading, writing, and speaking of English • 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. • 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

• Home-based