Clinical Research Associate (Part time)

Role overview

This part-time Clinical Research Associate role is centered on end-to-end management of clinical study sites, starting from site identification and selection through study initiation, ongoing monitoring, and final close-out. The position requires working in line with Tigermed or sponsor SOPs, ICH-GCP, GCP, and all other relevant regulations. A key objective is to make sure site-generated data remains accurate, timely, and delivered within budget.

Site management

• Carry out pre-study site visits to confirm that selected sites meet sponsor criteria, including sufficient experience and resources.
• Plan and lead site initiation visits to train relevant site personnel so the study can start and continue in accordance with the protocol and regulatory requirements.
• Manage clinical monitoring activities, including monitoring visits based on the SDV plan and SOPs.
• Resolve site issues promptly and submit monitoring visit reports on time while coordinating follow-up actions.
• Oversee recruitment progress to help ensure targets are met across assigned studies.
• Arrange study supplies and materials such as investigational product, non-drug items, equipment, and CRFs for start-up and ongoing conduct of the trial.
• Prepare the site-specific ethics committee submission package and support its submission.

Training

• Provide continuous guidance to site staff on ICH-GCP, GCP, protocol requirements, and study-specific procedures.
• Deliver site initiation training to confirm the site fully understands the protocol and operational expectations.

Documentation

• Collect essential study documents on time during start-up, conduct, and close-down, ensuring they meet protocol and regulatory standards.
• Maintain investigator files and trial master files with accurate, up-to-date records.
• Complete archiving of study records according to sponsor and protocol requirements.

Drug safety

• Distribute safety-related information to all participating sites in line with SOPs and applicable regulations.
• Ensure serious adverse events are reported within the required timelines and in compliance with SOPs and regulations.

Finance and administration

• Complete site budget finalization and secure the signed site contract before the site initiation visit.
• Make sure the study payment schedule is implemented and supporting documents and receipts are retained properly.

Study tools and systems

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

Qualifications

• Bachelor’s degree or higher in Medicine, Pharmacology, Biology, or a related discipline.
• 1 to 3 years of CRA experience.
• Strong working knowledge of Good Clinical Practice and clinical trial operations.
• Proficiency with Microsoft Word, Excel, PowerPoint, Outlook, and similar tools.

Additional information

This role is intended for candidates who can take ownership of project management and site oversight responsibilities for assigned clinical studies. Strong candidates who bring exceptional capability may be considered even if they do not fit every stated requirement exactly.