Deskripsi Pekerjaan
Join IQVIA as a Clinical Research Associate and drive innovation in healthcare through clinical trial excellence. This pivotal role requires you to conduct comprehensive site monitoring visits – including selection, initiation, routine monitoring, and close-out activities – while strictly adhering to contracted scope of work and global regulatory standards. You'll ensure protocol compliance, data integrity, and patient safety across diverse clinical research sites, contributing to the development of life-changing therapies.
Your responsibilities will involve meticulous review of clinical documentation, verification of trial processes against Good Clinical Practice (GCP) guidelines, and proactive identification of protocol deviations. You'll serve as the primary liaison between investigative sites and internal project teams, maintaining clear communication channels and resolving operational challenges. This position offers dynamic exposure to therapeutic areas and regulatory landscapes, ideal for professionals passionate about accelerating medical breakthroughs.
Tanggung Jawab
- Execute site monitoring visits (selection, initiation, monitoring, close-out) per contracted scope and SOPs
- Ensure strict adherence to GCP, ICH guidelines, and local regulatory requirements
- Verify source data accuracy and maintain audit trail integrity
- Identify protocol deviations, safety concerns, and implement corrective actions
- Facilitate site initiation training and ongoing protocol education
- Generate detailed monitoring reports with actionable insights
- Collaborate with CRAs, project managers, and clinical operations teams
Kualifikasi
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or related field
- 1-3 years clinical research experience with site monitoring exposure
- Certified Clinical Research Associate (CCRA) or equivalent certification preferred
- Proficiency in EDC systems (e.g., Medidata Rave, Oracle Inform) and CTMS
- Strong understanding of FDA, EMA, and Philippine FDA regulations
- Exceptional communication and interpersonal skills for site relationship management
- Ability to travel domestically (up to 40%) and manage competing priorities