Clinical Research Associate II

1w1 week ago

Caidya

Beijing, CN · Full-time · CNY 350,000 – CNY 550,000

About this role

The Clinical Research Associate II monitors investigational sites to ensure subject safety and provides high quality data review and reporting. Compliance follows Caidya and/or client SOPs, GCP/ICH guidelines, ISO14155, and applicable regulations. The role builds, manages, and supports site relationships as liaison between Sponsor and sites.

Serves as primary contact for assigned research sites and verifies investigator, staff, and site facilities remain adequate. Schedules and conducts pre-study, initiation, interim monitoring, and close-out visits per the Monitoring Plan. Ensures sites conduct studies according to protocol and regulations while protecting trial subjects' rights and well-being.

Performs source data verification against CRF/eDC entries and resolves data queries timely. Manages investigational product accountability and verifies adverse event reporting per requirements. Reconciles site regulatory binders and collects essential documents from start-up through close-out.

Provides support to Project Team and Clinical Operations Team while communicating deviations to investigators and management. Delivers quality trip reports and follow-up letters within SOP timelines. Participates in team teleconferences, training, investigator meetings, and site audits as requested.

Requirements

Maintain working knowledge of protocols and Monitoring Plans for assigned projects
Demonstrate strong written and verbal communication skills
Knowledge of Good Clinical Practice (GCP)/ICH guidelines, ISO14155, and applicable regulations
Experience verifying investigator and site adequacy throughout trials
Ability to perform source data verification and ensure data quality/completeness
Familiarity with investigational product accountability and adverse event reporting
Skill in reconciling site regulatory binders and collecting essential documents

Responsibilities

Serve as primary contact for assigned research sites
Schedule and conduct pre-study visits, initiation visits, interim monitoring visits, and close-out visits according to the Monitoring Plan
Ensure assigned sites conduct studies according to protocol requirements and applicable regulations
Verify rights and well-being of trial subjects and obtain informed consent
Perform source data verification against Case Report Form/eDC entries and resolve data queries
Perform investigational product accountability including storage, inventory, and dispensing records
Verify and support recording/reporting of adverse events/serious adverse events per requirements
Deliver quality written trip reports, confirmation, and follow-up letters within timelines