Clinical Research Associate II
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
Clinical Research Associate II monitoring investigator sites and clinical trial data for Parexel, a global clinical development services company. Ensuring ICH/GCP compliance, documentation quality, and study progress.
Responsibilities:
- Conduct source data verification and ensure clinical trial data are submitted to data management in a timely manner
- Identify issues affecting study conduct and ensure appropriate closure
- Manage investigator site workloads and support efficient study execution
- Ensure studies comply with ICH/GCP, local laws, and client SOPs
- Maintain patient safety and report safety issues according to regulatory requirements
- Inform principal investigators and site staff of issues
- Develop corrective and preventive actions with investigators and site personnel
- Manage sites from site selection through study closeout
- Train site staff on protocols, amendments, and client processes
- Maintain sufficient knowledge of the product, protocol, and therapy area for investigator discussions
- Interact with healthcare professionals to enhance client credibility
- Ensure monitored data meets quality standards and is entered into client systems promptly
- Report site study progress after visits and catalog and manage issues to closure
- Maintain accurate site-level information in the clinical trials registry
- Obtain and coordinate Investigator Initiation Package documentation
- Maintain Site Master Files and logs
- Ensure ELARA and/or Trial Master File completeness and accuracy
- Quality-control relevant documents and generate site monitoring reports
- Maintain monitoring logs
- Complete required training, timesheets, expense reports, and CV updates
- Comply with Parexel processes, ICH-GCP, and applicable requirements
Requirements:
- Computer Literacy (word processing and spreadsheets, PowerPoint)
- Proficient in Chinese
- Good command of written and spoken English is required
- Good interpersonal skills and communication skills
- Flexible attitude toward work assignments and new learning; quick learner
- Ability to manage multiple and varied tasks, prioritize workload, and maintain attention to detail
- Willingness to work in a matrix environment and value teamwork
- At least 1.5 years of Clinical Monitoring/Site Management experience (2 years preferable)
- Global study monitoring experience is preferred
- Good knowledge of ICH/GCP and relevant international and local clinical research regulations
- Degree in Life Science, Nursing, Pharmacy, or other relevant educational background
- Bachelor’s degree or above, or equivalent
Similar Jobs
Clinical Research Associate II
Clinical Research Associate II monitoring clinical trials for ICON, a global healthcare intelligence organization. Ensuring protocol compliance, data integrity, and patient safety across study sites.
Lead Clinical Research Associate
Lead Clinical Research Associate overseeing monitoring, compliance, and study teams. Supporting pharmaceutical, biotechnology, and medical device research advancing treatments.
Clinical Research Associate II
Clinical Research Associate advancing AbbVie’s innovative medicines through clinical site monitoring. Supporting investigators, protocol compliance, patient safety, data integrity, and recruitment.
Decision Scientist – Clinical Informatics, Clinical Data Standards
Clinical informatics scientist activating CVS Health’s clinical data repository. Building standards, feature stores, documentation, and analytics assets for healthcare outcomes and AI/ML.
Clinical Research Associate II
Clinical Research Associate monitoring oncology trials for Precision for Medicine, a precision-medicine CRO. Managing investigative sites, regulatory submissions, and protocol-compliant study execution.
Clinical Research Associate II, Oncology
Clinical Research Associate II monitoring oncology clinical trials for IQVIA Biotech, a global clinical research services CRO. Managing sites from start-up through close-out.
Clinical Research Analyst
Clinical Research Analyst reviewing human-subject research submissions for Providence’s healthcare system. Supporting IRB members and ensuring regulatory compliance across Western states.
Clinical Study Manager
Clinical Study Manager leading medical-device clinical trials at NAMSA, a global MedTech development solutions provider. Managing sites, study deliverables, compliance, and cross-functional teams.
Senior Clinical Research Associate
Senior Clinical Research Associate supporting NAMSA’s medical-device clinical trials. Managing site monitoring, regulatory documentation, audits, study metrics, and clinical research operations.
Clinical Research Associate
Clinical Research Associate monitoring clinical trials for ICON, a global healthcare intelligence organisation. Ensuring protocol compliance, data integrity, and patient safety.
Senior Clinical Data Manager
Senior Clinical Data Manager leading end-to-end clinical data management for Indero, a global dermatology and rheumatology CRO. Building EDC databases, ensuring data quality, and supporting database lock.
Director, Clinical Research Billing
Director overseeing clinical research billing compliance, revenue cycle, and staff operations at Stanford Health Care. Managing coverage analysis, audits, invoicing, and clinical trial billing workflows.
Senior Clinical Research Specialist
Senior Clinical Research Specialist managing investigator-sponsored medical-device studies for Medtronic. Overseeing clinical compliance, contracts, budgets, logistics, and global research stakeholders.
Clinical Research Associate
Clinical Research Associate monitoring clinical trials for ICON, a global healthcare intelligence and clinical research organisation. Ensuring protocol compliance, data integrity, patient safety, and high-quality study data.
Senior Clinical Research Specialist
Senior Clinical Research Specialist managing investigator-sponsored research for Medtronic’s surgical medical-device business. Overseeing clinical operations, compliance, contracting, payments, and device logistics.
Clinical Data Manager
Clinical Data Manager leading clinical trial data management and data quality for ICON, a global clinical research organisation. Owning study data from start-up through database lock and close-out.
Clinical Research Associate II
Clinical Research Associate II monitoring diagnostic clinical studies for Karius, a genomic infectious-disease diagnostics company. Managing investigative sites, data verification, compliance, and monitoring visits.
Senior Clinical Research Associate
Senior Clinical Research Associate monitoring clinical trials for ICON, a global healthcare intelligence and research organization. Ensuring protocol compliance, data integrity, site performance, and regulatory standards.
Head of Clinical Research
Head of Clinical Research leading grants, publications, and research governance for CSD’s autism and developmental-services network. Advancing evidence-based ABA, telehealth, and technology-enabled care.
Clinical Research Associate II
Clinical Research Associate II advancing AbbVie’s innovative medicines through clinical trial site management. Monitoring sites, ensuring compliance, data integrity, recruitment, and patient safety.