FSP CRA (Level II)

Job description

Work Schedule Standard (Mon-Fri) Environmental Conditions Office 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 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