Clinical Research Associate (CRA) – Client Dedicated

About the role

The Clinical Research Associate (CRA) will perform and coordinate clinical monitoring and site management for client‑dedicated research projects. The role ensures that trials adhere to approved protocols, ICH‑GCP guidelines, applicable regulations, and internal SOPs.

Key responsibilities

• Monitor investigator sites using risk‑based approaches, conduct source document review, source data verification and case report form review to confirm data accuracy.
• Assess investigational product inventory, document observations, escalate deficiencies and follow issues through resolution.
• Maintain regular contact with sites, participate in investigator meetings, initiate new sites and manage close‑out activities.
• Ensure essential documents are complete, perform on‑site file reviews and keep trial management systems up‑to‑date.
• Provide trial status updates to the Clinical Team Manager and facilitate communication among sites, the client company and the project team.
• Respond to audits and inspections, complete expense reports, timesheets and contribute to process improvement initiatives.

Required profile

• Bachelor's degree in a life‑science related field, Registered Nursing certification, or equivalent qualification.
• At least one year of clinical research monitoring experience or completion of the PPD Drug Development Fellowship.
• Valid driver’s license where applicable.

Required skills

• Clinical monitoring and site management expertise.
• Source document review, source data verification, and case report form review.
• Investigational product inventory management.
• Working knowledge of ICH‑GCP, applicable regulations and SOPs.
• Risk‑based monitoring methodology.