FSP CRA (Level II)

Job Description :

Work Schedule

Environmental Conditions

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