Clinical Research Associate

Job purpose

This role focuses on coordinating clinical studies and managing study sites from selection and initiation through monitoring and close-out. Work must follow Tigermed or sponsor SOPs, ICH-GCP, GCP, and other applicable regulations. The position is also accountable for ensuring that site-generated data remains accurate, timely, and within budget.

Key responsibilities

• Build project schedules and study timelines based on the project objectives and sponsor expectations.
• Plan, organize, and run meetings and teleconferences such as investigator meetings and project review sessions, while tracking site progress and overall study status.
• Prepare project management plans, monitoring plans, and other study-specific documents as needed.
• Create study tools, forms, and templates tailored to the project.
• Support and control the project budget.
• Arrange and verify that all clinical supplies, including drug and non-drug materials, are sufficient for every site throughout the study.
• Make sure all team members have timely access to the required systems and tools, including platforms such as IVRS and eCRF where applicable.
• Plan and carry out site feasibility visits in line with guidelines, and recommend whether sites should be approved.
• Monitor study milestones and keep the project aligned with the agreed plan.
• Share new study information, timelines, goals, and requirements with monitors, and escalate project-specific concerns to management when needed.
• Submit weekly project updates to management.
• Handle site selection, site initiation visits, and clinical monitoring activities.
• Conduct pre-study visits to confirm that potential sites meet sponsor criteria, including suitable resources and relevant experience.
• Run site initiation visits and ensure site staff receive proper training before study start so the trial is conducted according to protocol and regulations.
• Provide continuing training to site staff on ICH-GCP, GCP, protocol requirements, and study procedures.
• Ensure essential study documents are collected on time and remain compliant from study start-up through close-out, and keep investigator files and trial master files current.
• Complete budget finalization and secure signed site contracts before the site initiation visit.
• Support and coach entry-level CRAs, CRA I, and CRA II staff in coordination with the line manager.

Qualifications

• A bachelor’s degree or higher in a medical, pharmacology, biology, or closely related field.
• Solid understanding of Good Clinical Practice and clinical trial operations.
• 1 to 3 years of experience as a Clinical Research Associate.
• Strong written and spoken English communication.
• Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and similar tools.
• Effective communication and information-gathering skills; prior medical practice exposure is considered an advantage.

Additional information

Applicants who bring enthusiasm and creative thinking are encouraged to share their profiles.