Senior Clinical Research Associate I

7 days ago

Beijing, Beijing, China Parexel Full time
Drive Study Performance and Excellence

As a Senior Clinical Research Associate at Parexel, you will play a critical role in driving study performance at our sites. Your responsibilities will include performing site monitoring and other onsite visit activities according to the monitoring plan and in compliance with procedural documents. You will provide the required monitoring visit reports within the required timelines and proactively identify study-related issues to escalate to the Local Study Teams as appropriate.

Contribute to Site Selection and Training

You will contribute to the selection of potential sites and investigators, train, support, and advise Investigators and site staff in study-related matters. Your expertise will be essential in obtaining and maintaining essential documentation in compliance with ICH-GCP, Procedural Documents, and local regulations. You will manage study supplies, drug supplies, and drug accountability at study sites.

Ensure Data Quality and Integrity

You will perform source data verification according to the SDV plan, ensure data query resolution, and work with data management to ensure the quality of the study data. You will also ensure accurate and timely reporting of Serious Adverse Events and share relevant information on patient recruitment and study site progress within the local Study Team. You will update VCV and other systems with data from centers as per the required timelines.

Prepare for Audits and Regulatory Inspections

You will prepare for activities associated with audits and regulatory inspections in liaison with the local Study Team Lead and QA. You will adhere to the client's Code of Conduct and company policies and procedures. Additional tasks assigned by your manager may include study-level tasks associated with the Country Study Manager (CSM), acting as a mentor for junior team members, and co-monitoring less-experienced CRAs within the study team.

Contribute to Process Improvements and Knowledge Sharing

You will contribute to process improvements, knowledge transfer, and best practice sharing. You will comply with the required training curriculum, complete timesheets accurately as required, submit expense reports as required, update your CV as required, and maintain a working knowledge of and comply with Parexel processes, ICH-GCPs, and other applicable requirements.

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