Senior Clinical Research Associate

AstraZeneca; Petaling Jaya; On-site; MYR 60,000 - 80,000; Full time

Job summary

A global healthcare company is seeking a Clinical Research Associate (SrCRA) in Petaling Jaya, Malaysia. The SrCRA will be responsible for the delivery of studies, ensuring compliance with procedural documents and regulations. Responsibilities include managing study start-up, monitoring sites, and training staff. The ideal candidate will have a bachelor’s degree, knowledge of ICH-GCP, and strong communication skills. Join an inclusive team that values diversity.

Qualifications

• Bachelor’s degree in a related discipline required.
• Knowledge of ICH-GCP and local regulations.
• Strong communication and collaboration skills.

Responsibilities

• Supporting investigator selection and site qualification.
• Managing study start-up and regulatory submissions.
• Training and supporting investigators and site staff.
• Initiating, monitoring, and closing study sites.
• Ensuring compliance with all regulatory and company policies.

Skills

Knowledge of ICH-GCP

Good communication skills

Collaboration skills

Education

Bachelor’s degree in a related discipline

Job description

The Clinical Research Associate (SrCRA) has local responsibility for the delivery of studies at assigned sites and actively participates in local study teams.

The SrCRA collaborates closely with other CRAs and the Local Study Team/LSAD to ensure timely and efficient study commitments. As the main contact at the study site, the SrCRA monitors study conduct to ensure proper delivery and compliance with AZ procedural documents, ICH-GCP, and local regulations.

Responsibilities include the preparation, initiation, monitoring, and closure of sites, as well as supporting site staff training, study start-up activities, data management, and regulatory compliance. The SrCRA may take on additional responsibilities based on experience, including tasks associated with LSAD.

Key accountabilities include:

1. Supporting investigator selection and site qualification.
2. Managing study start-up and regulatory submissions where applicable.
3. Training and supporting investigators and site staff.
4. Participating in study team meetings and national investigator meetings.
5. Initiating, monitoring, and closing study sites, ensuring study progress and data quality.
6. Performing monitoring visits, data reviews, and risk assessments.
7. Ensuring timely data query resolution and report preparation.
8. Supporting audits and inspections, maintaining inspection-ready site files.
9. Ensuring compliance with all regulatory and company policies.

Qualifications include a bachelor’s degree in a related discipline, knowledge of ICH-GCP, local regulations, and good communication and collaboration skills.

The posting date is 29-Jul-2025, with a closing date of 25-Ogo-2025. AstraZeneca promotes diversity and inclusion, welcoming applications from all qualified candidates.