Clinical Research Associate II

Parexel

Clinical Research Associate II implementing and monitoring clinical trials ensuring compliance with regulatory requirements. Collaborating with clinical teams to resolve trial-related issues and conduct audits.

Posted 7/30/2026full-timeRemote • 🇨🇳 ChinaJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in clinical trial monitoring, including site qualification, data verification, and adherence to ICH GCP guidelines. Proficient in communication with investigative sites and facilitating audits while ensuring compliance with regulatory standards.

Highest-signal resume keywords

Clinical Monitoring ExperienceICH GCP GuidelinesSite QualificationData VerificationCoaching/Mentoring

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial MonitoringData VerificationSite File ReconciliationSAE ReportingRegulatory Compliance

Soft Skills

CommunicationTeam CollaborationProblem Solving

Tools & Technologies

Tracking SystemsMonitoring Activity Documents

Certifications & Qualifications

Licensed Healthcare Professional

Industry Keywords

Clinical TrialsInvestigative SitesRegulatory Authority RegulationsDrug DevelopmentAudit Facilitation

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met.
Assesses the qualification of potential investigative sites and instructs site personnel on the proper conduct of clinical trials.
Reviews and verifies accuracy of clinical trial data collected, either on site or remotely.
Completes monitoring activity documents as required by SOPs or other contractual obligations.
Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues.
Performs essential document site file reconciliation and source document verification.
Verifies SAE reporting according to trial specifications and ICH GCP guidelines.
Communicates with investigative sites and updates applicable tracking systems.
Facilitates audits and audit resolution.

Requirements

What you’ll need

2 - 4 years of clinical monitoring experience required.
A licensed healthcare professional (i.e., registered nurse); or equivalent work experience required.
Read, write, and speak fluent English; fluent in host country language required.
Knowledge of ICH and local regulatory authority regulations regarding drug preferred.
An advanced degree (e.g., MS, MBA, PharmD, etc.) preferred.
Experience in monitoring all trial components (pre-study site visit [PSSV] to closeout visit [COV]) preferred.
Experience in coaching/mentoring other CRAs preferred.

Benefits

Comp & perks

Health insurance
Professional development opportunities