Clinical Research Associate (CRA)

• Department: RA/QA
• Location: Beijing
• Reports to: CEO

Job Description

Role Summary

Clinical Research Associates (CRA) in collaboration with other functions, this role ensures document consistency, scientific integrity, data quality, and compliance with international Good Clinical Practices (GCP), regulations, and internal policies and procedures. They are part of a dynamic and growing Operations team that provides research, scientific, and domain expertise across interventional and diagnostic clinical research programs.

Essential Responsibilities

• Partners with Clinical Affairs Project Managers, Project Coordinators, Data Managers, cross-functional study teams, and other internal and external stakeholders to achieve project- and/or study-specific goals and associated timelines. 
• Partners with study team to contact potential investigators, and participates in selection of qualified investigators and sites for clinical trials. 
• Partners with Clinical Affairs Project Managers to develop monitoring plans. 
• Performs qualification, initiation, interim, and closeout monitoring visits. 
• Coordinates monitoring visit schedules in collaboration with Clinical Affairs Project Managers, Senior CRA, and site personnel. 
• Conducts study-specific training at study sites. 
• Coordinates and disseminates pertinent study documentation such as study protocols, case report forms, and site regulatory binders. 
• Manages study progress by tracking regulatory and ethics committee submissions, enrollment, case report form completion, data query resolution, and other activities and documentation at study sites. 
• Ensures all research activities are conducted compliantly, per the study protocol, local regulatory requirements, and GCP. 
• Ensures compliant recording and reporting of adverse events, protocol deviations, and product defects/complaints. 
• Reviews study documentation such as protocols, informed consents, amendments, case report forms and study reports. 
• Reviews ethics committee reports. 
• Generates timely and comprehensive monitoring visit/trip reports. 
• Reviews clinical history file/trial master file for completeness throughout lifecycle of study. 
• Influences and supports creation of functional standard operating procedures and job aids. 
• Assists with managing performance of Third Party Vendors. 
• Facilitates and participates in project, study, and functional team meetings. 
• Assists in planning and preparing for investigator and regulatory meetings. 
• Performs other work-related duties as assigned by Senior CRA and/or department lead. 
• Travels to other facilities and investigator/collaborator sites, as required.

Qualifications/Requirements

• RN or Bachelor’s degree in a science, technology, or statistical related field (or internationally recognized equivalent) .
• Minimum of 3 years’ clinical trial monitoring experience in the pharmaceutical or medical device industry. 
• Experience with electronic data capture (EDC) systems, such as Oracle InForm and Medidata Rave. 
• Working knowledge of international regulatory requirements and industry standards, including GCP. 
• Strong problem solving, influencing and negotiation skills. 
• Excellent written and verbal communication skills. 
• Proficient in Microsoft Office and Windows applications. 
• Willing to travel, as required (up to 100%). 
• Combination of performance, education, and prior related experience may be considered as equivalent to the above requirements provided that the individual possesses the knowledge, skills, and abilities to perform the job requirements.

Desired Characteristics

• Clinical trial professional certification such as CCRP, CCRA or CCRN. 
• Experience interfacing with regulatory agencies such as U.S. FDA, European competent authorities and notified bodies, Health Canada, SFDA, KFDA, MHLW, NMPA. 
• Experience training in a clinical environment. 
• Experience with clinical trial design, conduct, and reporting, and associated regulations. 
• Knowledge of international standards for medical devices (e.g. ISO 14155:2011). 
• Experience monitoring clinical trials involving medical devices
• Knowledge of Quality Management Systems (QMS)
• Experience working across cultures and global regions
• Expert in Microsoft Office and Windows applications
• Project management experience including the ability to prioritize, plan, and evaluate deliverables; is well organized and structured, strong attention to detail.
• Demonstrated experience prioritizing conflicting demands from multiple business entities in an extremely fast paced environment.
• Demonstrated ability to work well independently and in a team setting.
• Presentation skills with the ability to communicate business issues in English.

    

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Director of Regulatory Affairs

• Department: RA/QA
• Location: Beijing
• Reports to: CEO

Job Description :

To ensure company business objectives achieved through:

• Initial NMPA registration and renewal the products of company.
• Report to NMPA about product change and get approval timely.
• Plan and implement internal audit to make sure compliance for both internal and external requirement on regulatory point of view.
• 4Follow up and help the registration and clinical trial affairs for RA and CRA specialist.

Duties:

• Registering and renewing medical device licenses in NMPA and other special.
  approval on time as per the registration priority list.;
• Quality control the registration application and dossier, follow up the evaluation procedure,
  solve problem in registration.
• Report product change to NMPA: Communication and report NMPA if there is any change on approved products, arrange gap time solution during the approval time.
• Supervise and assist RA/QA specialist for the registration affairs;.
• Plan and implement internal audit to make sure compliance for both internal and external requirement on regulatory point of view.

• Maintain Chinese IFU & Label comply with NMPA requirements.
• Responsible for supporting NMPA inspection.
• FDA registration of Chinese made medical disposables.
• Coordinate and assure the proper design and execution of clinical trials.
• Building up regulatory teams.

Qualification / Experience/ Skills Required

• Excellent communication skill and interpersonal skill.
• fully understand NMPA/FDA regulation on product registration, marketing supervision and etc.
• Experience transitioning US FDA approved products into Chinese market preferred.
• With a minimum of 8 years regulatory experience as RA function in medical monitor industry.
• Bachelor's degree or above in related medical and electro - mechanical expertise.
• Clinical background and clinical trials experience are preferred.
• Ability to manage projects and timelines.
• Proficient oral and written communication in Chinese and English.