CRA II
On-site · Manila, Metro Manila, Philippines
Job Summary
CRA II responsible for site qualification, initiation, interim monitoring, site management, and close-out visits (on-site or remote) ensuring regulatory, ICH-GCP and GPP protocol compliance. Duties include evaluating site performance, communicating issues to the project team, maintaining knowledge of ICH/GCP guidelines, verifying informed consent, protecting subject confidentiality, assessing safety/data integrity, conducting source document review and CRF data accuracy, remote and on-site query resolution, supporting IP inventory and labeling per protocol, archiving ISF/TMF, supporting subject recruitment and retention, tracking observations, and participating in sponsor meetings and audits. Requires strong written/reported documentation, adaptability to changing priorities, and up to 75% travel; US deployment considerations noted. Education or RN in related field or equivalent experience; travel-ready and compliant with GCP requirements.
Required Qualifications
- Bachelor’s degree or RN in a related field or equivalent combination of education, training and experience
- Knowledge of Good Clinical Practice/ICH Guidelines and other applicable regulatory requirements
- Excellent communication, presentation and interpersonal skills
- Ability to manage required travel of up to 75% on a regular basis
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