Senior Clinical Research Associate I

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

📋 Description

• Execute clinical studies at designated sites and engage in local study teams.

• Act as the primary liaison for study sites and oversee the study process.

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

• Assist in investigator selection and activities related to study initiation.

• Aid in regulatory submissions and maintenance with EC/IRB and Regulatory Authorities as necessary.

• Train, support, and provide guidance to investigators and site personnel on study-related topics and RbQM principles.

• Verify necessary site staff training and uphold inspection readiness.

• Participate in Local Study Team and National Investigators meetings as applicable.

• Enhance site performance and address or escalate study-related challenges.

• Update CTMS and other relevant systems with study-site information.

• Oversee study supplies, drug supplies, drug accountability, and drug destruction when needed.

• Conduct remote and onsite monitoring visits along with remote data verifications.

• Execute SDR, CRF reviews, SDV, site quality risk assessments, and modify monitoring intensity as appropriate.

• Ensure prompt query resolutions and collaborate with data management on study data quality.

• Accurately and swiftly report Serious Adverse Events and follow-ups.

• Prepare and finalize monitoring visit reports while providing feedback to Principal Investigators.

• Follow up on pending site actions.

• Escalate quality concerns, data privacy violations, CSP, or ICH-GCP compliance issues.

• Assist sites in keeping inspection-ready ISFs.

• Collaborate during audits and regulatory inspections.

• Gather and upload essential documents to the eTMF and assist with QC checks.

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

• Provide research-related insights valuable for the local market.

• Adhere to AstraZeneca’s Code of Ethics, policies, procedures, and relevant legislation.

• Work in conjunction with local MSLs as directed.

⛳️ Requirements

• A minimum of 3–5 years’ experience as a monitor.

• Capable of working independently and monitoring all phases of a study.

• Frequently possesses specialized therapeutic expertise.

• Competent in undertaking LSL tasks and assisting the LSL with coordination or document preparation as needed.

• Willingness to travel internationally as required.

• Possession of a valid driving license.

• Adherence to ICH-GCP, AZ Procedural Documents, AZ SOPs, local, national, and regional regulations, as well as AstraZeneca policies and procedures.

• Proficient in performing clinical research monitoring, including SDR, CRF reviews, SDV, remote data checks, site quality risk assessments, and monitoring visits.

• Ability to manage study supplies, drug supplies, and drug accountability.

• Familiarity with CTMS, eTMF, and other study systems.

• Capable of supporting regulatory submissions, study initiation, and regulatory maintenance as necessary.

• Ability to train and guide investigators and site staff.

• Ensure timely reporting of Serious Adverse Events and follow-ups.

🏝️ Benefits

• Fully remote work arrangement.

• Full-time employment.