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.
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.

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.
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

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Applicant Tracking System Keywords

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Hard Skills & Tools

clinical operationsproject managementmonitoring plan preparationprotocol deviation trackingreport writingEDC systems proficiencyGCP knowledgeICH guidelines understandingenrollment strategies implementationrecruitment strategies implementation

Soft Skills

strong written communicationstrong verbal communicationinterpersonal skillsorganizational skillsdetail orientedproactivetask-drivenhighly organizedability to handle multiple tasksability to meet deadlines

Certifications

SoCRA CertificationACRP Certification