Clinical Research Associate (CRA)

Expecto Health Science; Kuala Lumpur; Hybride; MYR 60 000 - 120 000; Plein temps

Résumé du poste

Expecto Health Science in Malaysia is seeking a Clinical Monitoring professional to perform on-site and remote monitoring, ensuring adherence to the study protocol, regulations, and GCP requirements.

The role involves reviewing CRFs and source documents, documenting deviations, communicating with investigators and sponsors, and supporting site initiation, routine monitoring, and close-out activities while keeping meticulous trial records.

Qualifications

• Ability to communicate effectively with investigators and teams.
• Strong organizational and time-management abilities.
• Good problem-solving and analytical skills.
• Excellent attention to detail and accuracy.
• Willingness to travel to trial sites as required.

Responsabilités

• Conduct on-site and remote monitoring visits to ensure GCP and protocol compliance.
• Review CRFs and source documents for data accuracy and completeness.
• Identify and follow up on protocol deviations and data discrepancies.
• Communicate with investigators, site staff, sponsors, and teams to support progress.
• Prepare monitoring visit reports and close action items on time.
• Support site initiation, routine monitoring, and close-out activities.
• Maintain trial documentation and aid inspection readiness.

Connaissances

Communication skills

Organizational skills

Problem-solving

Attention to detail

Multitasking

Travel willingness

Formation

Degree in Life Sciences / Pharmacy / Nursing / Medicine

Description du poste

Key Responsibilities

• Conduct on-site and remote monitoring visits to assess site compliance with the study protocol, applicable regulations, and GCP requirements.
• Review clinical trial documentation, source records, and Case Report Forms (CRFs) to ensure data accuracy, completeness, and consistency.
• Identify, document, and follow up on protocol deviations, data discrepancies, and other site-related issues.
• Communicate effectively with investigators, site staff, sponsors, and cross-functional teams to support study progress.
• Prepare monitoring visit reports and follow up on outstanding action items within the required timelines.
• Support site initiation, routine monitoring, and close-out activities, as applicable.
• Maintain appropriate trial documentation and contribute to inspection and audit readiness.

Candidate Profile

• A degree in a relevant field, such as Life Sciences, Pharmacy, Nursing, Medicine, or a related discipline.
• Minimum 2 years experience in clinical research or clinical trial monitoring is preferred.
• Knowledge of ICH-GCP principles and applicable clinical trial regulations.
• Strong communication, organizational, and problem-solving skills.
• Excellent attention to detail and the ability to manage multiple priorities effectively.
• Willingness to travel to clinical trial sites as required.