Clinical Research Associate

Job overview

This role is responsible for managing clinical study projects and coordinating sites from selection and start-up through monitoring and close-out. The position must ensure activities are carried out in line with Tigermed or sponsor SOPs, ICH-GCP, GCP, and other applicable regulations. A key part of the job is making sure the data produced at assigned sites is accurate, timely, and delivered within budget.

Site management

• Identify suitable study sites, complete initiation activities, and carry out clinical monitoring.
• Perform pre-study visits to confirm that proposed sites meet sponsor selection criteria, including sufficient resources and relevant experience.
• Plan and lead site initiation visits so site teams are properly trained and ready to begin the study in compliance with protocol and regulations.
• Make sure the Principal Investigator and site staff follow safety reporting obligations under the protocol, SOPs, ICH-GCP, and GCP.
• Monitor recruitment progress and work to ensure enrolment targets are met across studies.
• Conduct monitoring visits based on the source data verification plan and SOPs, resolve site issues, and submit monitoring visit reports on time.
• Coordinate timely delivery of study materials such as drug, non-drug supplies, equipment, and CRFs to sites throughout start-up and study conduct.
• Prepare site-specific ethics committee submission packages and ensure they are submitted appropriately.

Training

• Provide continuing guidance to site teams on ICH-GCP, GCP, the protocol, and study-specific requirements.
• Lead site initiation activities to ensure the site fully understands the protocol and operational expectations.

Documentation

• Collect essential documents on time during study start-up, conduct, and close-down, in line with protocol and regulatory requirements.
• Maintain and refresh investigator files and trial master file records.
• Complete archiving of study records according to protocol and sponsor instructions.

Drug safety

• Share safety information with all participating sites in accordance with SOPs and applicable regulations.
• Ensure serious adverse events are reported within required timelines and as per governing procedures.

Finance and administration

• Conclude site budgets and obtain signed contracts before the site initiation visit.
• Make sure the study payment schedule is carried out and keep the related documents and receipts on file.

Study tools and systems

• Keep study tools and systems updated and maintained without delay.

Qualifications

• Bachelor’s degree or higher in a field related to medicine, pharmacology, or biology.
• At least 1 year of experience as a Clinical Research Associate.
• Strong working knowledge of Good Clinical Practice and clinical trial processes.
• Comfortable using Microsoft Word, Excel, PowerPoint, Outlook, and related tools.

Additional information

The company notes that strong candidates may be considered even if they do not fully match the stated requirements.