General Description:
・Key Clinical Operations support role; ensures that delegated components of clinical trials are executed to expected and specified quality standards
・Builds basic knowledge of clinical trials operations and scientific principles and objectives of the company’s clinical trials under some direction and guidance of senior staff but largely self-directed; works independently but knows when to involve / collaborate with others
・Learns best practices in clinical operations methodologies, systems and processes, with particular emphasis on quality, time standards and expectations
Essential Functions of the job:
・Organize Clinical Operations department meeting/teleconference
・Write meeting minutes, if required
・Maintain department files
・Update department trackers
・Assist in preparing/update clinical trial related tracking/slides
・Assist in clinical trial related printing, shipment, purchasing and contract signature and all the administrative work.
・Assist CTMS management
・Assist CRA activities for SIV and COV
・eTMF submitter (document management, overdue check and QC f/u)
・Performs QC of Trial Master Files; creates, maintains, and closes out TMFs; is key in set up, conduct, and close out of ancillary services for company clinical trials
・Local Vendor Registration support
・Customer clearance to import IP and lab kit
・SUSAR and other safety report submit to the local IRB and PI/ Site Director
・Support payment for the investigational fee and study related cost.
Description for focusing on Japan:
・Support to build Japan organization and required process such as Local SOP and WI.
・Support regional CSM for Japan specific regulations and tasks.
・Supports PMDA inspection
・Other tasks, if needed.