Clinical Research Associate

Tigermed is hiring a Clinical Research Associate (CRA) to manage assigned clinical study sites from selection and initiation through monitoring and close-out. The role ensures clinical trial data quality, timeliness, and budget adherence while following SOPs, ICH-GCP, GCP, and applicable regulations.

• Plan project activities and study timelines based on project goals and sponsor expectations.

• Organize and lead meetings/teleconferences (e.g., investigator meetings, project review meetings) and monitor site progress and overall project status.

• Develop project management plans and monitoring plans as required.

• Create study-specific tools/forms and templates.

• Develop and manage the project budget.

• Order and ensure adequate clinical supplies (drug and non-drug) for all sites throughout the study.

• Ensure team members have timely access to required systems and tools (e.g., IVRS, eCRF).

• Conduct site feasibility visits and provide recommendations for final site approval.

• Track study progress and ensure the project is conducted according to plan.

• Communicate study information, timelines, goals, and requirements to monitors; escalate project-specific issues to management.

• Submit weekly project reports to management.

• Perform site selection, site initiation visits (SIV), and clinical monitoring.

• Conduct pre-study visits to confirm sites meet sponsor selection criteria (resources, experience, etc.).

• Prepare and conduct SIV to train site staff and enable compliant study start and conduct.

• Provide ongoing training to site staff on ICH-GCP, GCP, protocol, and study requirements.

• Collect, maintain, and update essential documents in investigator files and trial master files from start-up through close-out.

• Finalize site budget and obtain signed site contract prior to SIV.

• Guide and train entry-level CRA/CRA I/CRA II in collaboration with the line manager.

• Bachelor degree or above in a Medical, Pharmacology, Biology, or related major.

• Good understanding of Good Clinical Practice (GCP) and clinical trial operations processes/procedures.

• 1–3 years of CRA experience.

• Good written and verbal English.

• Proficiency with Microsoft Word, Excel, PowerPoint, and Outlook.

• Strong communication and information-gathering skills.

• Knowledge and/or experience in medical practice is a plus.

Not specified.