Clinical Research Associate II

This is a fully remote position, open to applicants in Vietnam.

📋 Description

• Assist in the execution of clinical studies at designated sites as an integral member of local study teams.

• Act as the primary liaison with study sites and oversee the conduct of studies.

• Prepare, initiate, monitor, and conclude assigned clinical study sites.

• Contribute to the selection of investigators and, when necessary, assist with study initiation and regulatory maintenance.

• Train, support, and provide guidance to investigators and site personnel on study-related issues and Risk-based Quality Management (RbQM) principles.

• Confirm required training for site staff and ensure readiness for inspections.

• Participate in local study team meetings and national investigator gatherings.

• Promote site performance, address study-related challenges, and escalate issues as necessary.

• Update the Clinical Trial Management System (CTMS) and other platforms with site information.

• Manage study supplies, drug inventory, and accountability.

• Conduct both remote and onsite monitoring visits, perform remote data checks, site data review (SDR), Case Report Form (CRF) evaluations, and Source Data Verification (SDV).

• Execute site quality risk assessments and modify monitoring intensity as needed.

• Ensure prompt resolution of data queries and accurate reporting of Serious Adverse Events.

• Draft monitoring visit reports and provide feedback to Principal Investigators.

• Follow up on pending actions from sites.

• Escalate issues related to quality, privacy, and compliance.

• Assist in preparing for inspections, audits, and regulatory reviews.

• Gather and upload essential documents to the electronic Trial Master File (eTMF) and support quality control checks.

• Ensure that study documents are prepared for archiving and eTMF completion.

• Provide feedback on market research and collaborate with local Medical Science Liaisons (MSLs).

• Ensure adherence to company policies, ethical standards, and relevant regulations.

⛳️ Requirements

• 0–2 years of relevant experience preferred.

• Strong understanding of clinical research regulatory standards, including Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

• Excellent written and verbal communication abilities.

• Proficient command of the English language.

• Degree in a scientific field or healthcare.

• An equivalent combination of education, training, and experience may be considered in lieu of a degree.

🏝️ Benefits

• Fully remote work arrangement.