ESSENTIAL DUTIES AND RESPONSIBILITIES:

The primary responsibilities for the Senior Clinical Research Associate include:

·           Plan, implement and manage clinical trials and influences study design and interprets results. Define clinical trial protocols, standard operating procedures (SOPs) and case report forms (CRFs) for use in clinical trials operations. 

·           Develop clinical validation strategies, clinical study plans, and clinical protocols to evaluate safety and clinical efficacy aspects of products concept/prototype prior to product release, effectively drives action plan deliverables to OTD

·           Provide co-monitoring and trial quality control for CRA to ensure that clinical trials meet requirement of NMPA;

·           Organize and manage clinical trial investigator meetings for responsible projects;

·           Keep effective communication cross functionally and geographically.

·           Set up new clinical sites for responsible clinical trials, keep good relationship with investigators, KOLs;

·           Good interface with government agency, cultivate relationship with vendors, consultants, contractors and professional associations, engage in NMPA consultation, be clear with NMPA regulation and IVD clinical trial requirement.

·           Drive clinical evidence strategy for multiple projects (including leveraging oversea clinical data for local regulatory submission)

·           Drives sustainment & improvement of functional standard work

·           Oversea data submission

·           Lead and Identify the appropriate DBS tools to solve complex issues, utilize DBS to drive process improvement (i.e. creating SW, leading Kaizen, leading DM, leading PSP), manage risks, and propose the appropriate countermeasures

EDUCATION:

·         Education: BS/BA, Masters’ degree preferred

·         Experience: Candidates should have 5 years relevant work experience with BS degree, or 3 years of experience with MS or PhD. Prior demonstrated experience in the successful design/execution of premarket clinical research studies is highly preferred.

·         Business travel:  Ability to travel (20-35%% Domestic and/or international), and participation in professional activities outside of normal business hours