FSP CRA (Level II)

Work Schedule

Environmental Conditions

Job Description

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 2700 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.

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

Bachelors degree in life sciences or a related field or Registered Nurse qualification
Minimum 12 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 drivers licence is preferred (if applicable)

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

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