CRA (Level II)

Thermo Fisher Scientific Inc.; Kuala Lumpur; On-site; MYR 30,000 - 60,000; Full time

Job summary

Join a forward-thinking company dedicated to improving global health outcomes through innovative clinical research. In this role, you will leverage your clinical monitoring skills to ensure compliance and data accuracy across various clinical trials. Your contributions will directly impact the success of life-changing therapies, as you work collaboratively with a dynamic team to support clinical operations from start-up to close-out. With a strong emphasis on integrity and innovation, this position offers excellent career development opportunities in a supportive environment that values your expertise and dedication.

Benefits

Competitive remuneration

Annual incentive bonuses

Healthcare benefits

Career development opportunities

Qualifications

• 1+ years of experience in clinical research monitoring.
• Strong knowledge of ICH GCPs and applicable regulations.

Responsibilities

• Monitor investigator sites and ensure compliance with protocols.
• Provide trial status updates to Clinical Team Manager.
• Respond to audits and inspections.

Skills

Clinical monitoring skills

Understanding of medical terminology

Knowledge of ICH GCPs

Critical thinking

Problem-solving skills

Effective communication skills

Customer-focused

Education

Bachelor's degree in life sciences

Job description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner, and safer! We provide our teams with the resources needed to achieve individual career goals while advancing science through research, development, and delivery of life-changing therapies. Our work spans laboratory, digital, and decentralized clinical trial services, with clinical trials conducted in over 100 countries and ongoing development of innovative frameworks for clinical research within our PPD portfolio. Your dedication to delivering quality and accuracy will help improve health outcomes for people and communities now and in the future.

Our global Clinical Operations team within our PPD clinical research services provides comprehensive support for clinical trials from start-up to close-out, across both commercial and government contracts. We assist clients in defining and developing clinical programs, minimizing delays, and ensuring high-quality, cost-efficient studies.

• Monitor investigator sites using a risk-based approach, applying root cause analysis (RCA), critical thinking, and problem-solving skills to identify process failures and implement corrective and preventive actions to ensure compliance and reduce risks. Ensure data accuracy through SDR, SDV, and CRF review during on-site and remote monitoring. Assess investigational products via physical inventory and records review. Document observations promptly using approved business writing standards. Report deficiencies and issues to clinical management and follow through to resolution. Maintain regular contact with investigative sites to confirm protocol adherence, issue resolution, and timely data recording. Conduct monitoring activities in accordance with the approved plan. Participate in investigator payments and collaborate with other team members on issue resolution. Investigate and follow up on findings as applicable.
• Participate in investigator meetings as needed. Identify potential investigators in collaboration with the client to ensure site suitability. Initiate clinical trial sites following relevant procedures to ensure protocol and regulatory compliance, and make recommendations as appropriate. Oversee trial close-out and retrieval of materials.
• Ensure all essential documents are complete and compliant with ICH-GCP and regulations. Conduct on-site file reviews as per project specifications.
• Provide trial status updates and progress reports to the Clinical Team Manager (CTM). Ensure study systems are updated according to study conventions (e.g., Clinical Trial Management System).
• Respond to regulatory, client, and company audits and inspections.
• Complete administrative tasks such as expense reports and timesheets promptly.

Education and Experience:

• Bachelor's degree in a life sciences-related field or equivalent.
• At least 1 year of experience as a clinical research monitor or similar role, demonstrating relevant skills and knowledge.

Knowledge, Skills, and Abilities:

• Clinical monitoring skills and experience.
• Understanding of medical/therapeutic areas and medical terminology.
• Strong knowledge of ICH GCPs, applicable regulations, and procedural documents.
• Critical thinking, investigation, and problem-solving skills.
• Ability to manage Risk-Based Monitoring processes.
• Effective oral and written communication skills, with the ability to interact with medical personnel.
• Customer-focused with good listening skills, attention to detail, and ability to perceive underlying issues.

Benefits

We offer competitive remuneration, annual incentive bonuses, healthcare, and a range of employee benefits. Join Thermo Fisher Scientific for an innovative, forward-thinking environment with excellent career and development opportunities. Our company culture values integrity, engagement, and innovation!