Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Join Us as a Clinical Research Associate (Level II) – Make an Impact at the Forefront of Innovation
We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.
As part of our global FSP team, you will perform and coordinate all aspects of clinical monitoring and site management activities in close collaboration with the sponsor. As a Clinical Research Associate (Level II), you will conduct both on-site and remote monitoring visits to ensure protocol and regulatory compliance, as well as proper documentation.
Acting as a site management specialist, you will ensure that clinical trials are conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable local regulations, and SOPs. You will play a key role in ensuring subject safety, data integrity, and inspection readiness, while building strong relationships with investigational sites and sponsor stakeholders.
What You'll Do:
- Perform on-site and remote monitoring visits using a risk-based monitoring approach, including SDV, SDR, and source data review as applicable
- Apply root cause analysis (RCA), critical thinking, and problem-solving skills to identify site issues and implement corrective and preventive actions
- Ensure investigational sites comply with protocol, ICH-GCP, and applicable local regulatory requirements
- Review investigational product accountability, including physical inventory and documentation
- Prepare monitoring visit reports, follow-up letters, and other documentation in a timely and high-quality manner
- Escalate issues and follow through to resolution in collaboration with the CTM and sponsor team
- Maintain regular communication with sites between visits to ensure ongoing compliance and data quality
- Participate in site selection, site initiation, routine monitoring, and close-out activities
- Ensure essential documents are complete and maintained in compliance with ICH-GCP and applicable regulations
- Update study systems (e.g. CTMS) and provide study progress updates to the CTM as required
- Facilitate effective communication between investigational sites, sponsor, and internal project teams
- Support audits and inspections by ensuring audit readiness at site level
- Complete administrative tasks (e.g. expense reports, timesheets) in a timely manner
- Contribute to process improvements and team initiatives as applicable
Education and Experience Requirements:
- Bachelor's degree in life sciences or a related field, or Registered Nurse qualification
- Minimum 1–2 years of clinical monitoring experience (or equivalent), or completion of a recognized CRA training program
- Experience working in an FSP or sponsor-dedicated model is preferred
- Experience in site management and monitoring within Singapore is preferred
- Familiarity with local regulatory requirements (e.g. HSA) and site practices is an advantage
- Valid driver's licence is preferred (if applicable)
Knowledge, Skills and Abilities:
- Solid clinical monitoring skills with understanding of risk-based monitoring concepts
- Working knowledge of ICH-GCP, local regulatory requirements, and clinical trial processes
- Strong critical thinking and problem-solving skills
- Effective communication skills in English (additional regional language skills are a plus)
- Strong stakeholder management skills, including working with sponsor teams
- Good organisational and time management skills
- Attention to detail and commitment to quality
- Ability to work independently and collaboratively in a team environment
- Proficiency in Microsoft Office and ability to learn relevant systems
Working Conditions and Environment:
- This is a hybrid role, combining home-based work with on-site monitoring visits
- Regular travel to investigational sites within Singapore
- Occasional presence at sponsor or office locations may be required
- Work may involve exposure to clinical environments
