Clinical Research Associate (CRA), Clinical Trials Unit

Fairview International School; Kuala Lumpur; On-site; MYR 40,000 - 60,000; Full time

Job summary

A leading company in clinical research is seeking a Clinical Research Associate to assist in managing clinical trial operations and portfolios. The role involves developing trial documentation, monitoring compliance, and assisting in data management. Ideal candidates hold a degree in Life Sciences and have at least one year of relevant experience.

Qualifications

• Minimum 1 year of clinical research or monitoring experience.
• Knowledge of ICH guidelines and IRB requirements.
• Ability to maintain meticulous study documentation.

Responsibilities

• Manage clinical trial documentation and operations.
• Monitor compliance of clinical trials.
• Coordinate sample management and ensure compliance with protocols.

Skills

GCP knowledge

Organizational skills

Communication skills

Education

Degree in Life Sciences

Tools

REDCap

Job description

Clinical Research Associate (CRA), Clinical Trials Unit

To assist the Clinical Trials Manager (CTM) in managing the clinical trial portfolios and operations in line with CRMY’s strategy for the Clinical/Translational Research Programmes (the “Programme”).

Responsibilities:

Clinical Trial Operations:

Ensure all delegated activities/tasks are completed and meet the objectives within the specified timeframe and resources.

Work under the supervision of the CTM to:

• Develop clinical trial documentation and toolkits for CRMY-sponsored Trials and Investigator Initiated Trials.
• Plan and manage clinical trials, whether conceived internally or externally.
• Support the CTM in conducting study feasibility assessments for new clinical trials.

Study Monitoring:

• Coordinate with clinical trial teams to organize periodic study monitoring visits (on-site or remote) to ensure compliance with study protocols, GCP, ICH guidelines, ethics, and regulatory requirements.
• Advise trial teams on GCP compliance and propose resolutions for findings/issues during monitoring visits.
• Deliver monitoring reports after each visit.

Data Management:

• Assist in designing eCRFs and testing EDC systems prior to migration to production.
• Help draft CRF Completion Guidelines and Data Monitoring Guides for new trials.

Sample Management:

• Coordinate sample management for IITs, ensuring sufficient supply of study materials and updating sites on protocol changes related to sample collection/processing.
• Coordinate shipment of biospecimens from sites to CRMY labs.
• Ensure biospecimens are stored or archived as per protocol.

Escalate critical issues related to Study and Site Management to the CTM.

Compliance and Quality Management:

• Collaborate with the CTM and research teams to develop and refine SOPs for clinical trial operations.
• Provide consultation on SOP compliance.
• Maintain GCP certificates for involved staff and inform staff about GCP workshops in Malaysia.

Other Responsibilities:

• Represent the team and Cancer Research Malaysia when appropriate.
• Undertake other administrative tasks as required.

Requirements:

• Degree in Life Sciences or related fields, with at least 1 year of clinical research or monitoring experience.
• Good knowledge of GCP, ICH guidelines, and IRB/EC requirements.
• Experience with SOPs and EDC systems like REDCap.
• Ability to connect various elements for proper study conduct.
• Meticulous, organized, independent, and deadline-oriented.
• Excellent communication and interpersonal skills.