Job Overview:
Summary of Responsibilities:
- Conduct monitoring visits including Site Initiation, Routine Monitoring, and Close-out Visits.
- Ensure protocol compliance, patient safety, and data quality throughout the study.
- Perform source document review, data verification, and query management.
- Review and maintain site regulatory documentation and study files.
- Manage investigational product (IP) accountability, storage, reconciliation, and study supplies.
- Track and follow up on safety reporting, protocol deviations, and site issues.
- Support feasibility assessments, study start-up activities, and site management tasks.
- Prepare monitoring reports and maintain inspection-ready documentation.
- Collaborate closely with investigators, site staff, vendors, and project teams to ensure study milestones are achieved.
Qualifications (Minimum Required):
- Bachelor's Degree in Life Sciences, Nursing, Pharmacy, or a related healthcare discipline.
- Minimum 6 months of experience in clinical research, such as Clinical Research Coordinator (CRC), Research Nurse, IHCRA, Site Management, or similar roles.
- Basic understanding of ICH-GCP and local regulatory requirements.
- Fluent in English and Bahasa Malaysia, both written and spoken.
- Strong organizational, communication, and problem-solving skills.
- Ability to work effectively in a matrix and team-based environment.
Preferred Qualifications Include:
- Previous site monitoring experience.
- Experience with investigational product accountability and study supplies.
- Experience with CTMS, EDC, or other clinical trial systems.
- Strong attention to detail and documentation skills.
- Interest in progressing into an independent CRA role.
Learn more about our EEO & Accommodations request here.
Skills Required
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related healthcare discipline
- At least 6 months of clinical research experience, such as Clinical Research Coordinator, Research Nurse, IHCRA, or Site Management experience
- Basic understanding of ICH-GCP and local regulatory requirements
- Fluency in written and spoken English and Bahasa Malaysia
- Strong organizational, communication, and problem-solving skills
- Ability to work effectively in a matrix and team-based environment
- Previous site monitoring experience
- Experience with investigational product accountability and study supplies
- Experience with CTMS, EDC, or other clinical trial systems
- Strong attention to detail and documentation skills
What We Do
Fortrea (Nasdaq: FTRE) is a leading global provider of clinical development and patient access solutions to the life sciences industry. We partner with emerging and large biopharmaceutical, medical device and diagnostic companies to drive healthcare innovation that accelerates life changing therapies to patients in need. Fortrea provides phase I-IV clinical trial management, clinical pharmacology, differentiated technology-enabled trial solutions and post-approval services. Fortrea’s solutions leverage three decades of experience spanning more than 20 therapeutic areas, a passion for scientific rigor, exceptional insights and a strong investigator site network. Our talented and diverse team working in more than 90 countries is scaled to deliver focused and agile solutions to customers globally. Learn more about how Fortrea is becoming a transformative force from pipeline to patient at Fortrea.com.
