Clinical Trial Specialist

1 month ago


Shanghai, Shanghai, China SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch Full time
About the Role:

As a Clinical Trial Specialist at SHA Fortrea Pharmaceutical Research & Development (Beijing) Co Ltd Shanghai Branch, you will play a vital role in ensuring the quality and integrity of our clinical trials. Your primary responsibility will be to oversee all aspects of study site monitoring, including routine monitoring and closeout of clinical sites, maintenance of study files, conduct of pre-study and initiation visits, and liaison with vendors. You will also be responsible for site management as prescribed in project plans.

Responsibilities:

• Ensure the study staff conducting the protocol have received proper materials and instructions to safely enter patients into the study.
• Verify that informed consent procedures and protocol requirements are adhered to according to applicable regulatory requirements.
• Monitor data for missing or implausible data and ensure the integrity of data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review.
• Travel, including air travel, may be required and is an essential function of the job.
• Prepare accurate and timely trip reports.
• Interact with internal work groups to evaluate needs, resources, and timelines.
• Act as contact for clinical trial supplies and other suppliers (vendors) as assigned.
• Responsible for all aspects of registry management as prescribed in project plans.
• Undertake feasibility work when requested.
• Participate in and follow-up on Quality Control Visits (QC) when requested.
• Assist Senior CRA with managing investigator site budgets.
• Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives, and follow-up of SAEs.
• Independently perform CRF review; query generation and resolution against established data review guidelines on Company or client data management systems as assigned by management.
• Assist with training, mentoring, and development of new employees, e.g., co-monitoring.
• Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned.
• Perform other duties as assigned by management.

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