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Position Title:Clinical Research Associate I&II&III
Department:Clinical Operations
Location:Shanghai

Position Summary

Responsible for the site monitoring and coordination of all aspects of clinical studies assigned in accordance with ICH-GCP, and local regulatory requirements, and the Standard Operating Procedures (SOPs) of Sponsor and /or dMed. CRA needs to be flexible to manage various projects and capable to handle different therapeutic areas and different studies . Build and maintain the working relationship with site and investigators. The degree ( I & II & III ) of responsibility accorded to a CRA will reflect their level of experience and contribution that they can make to the project. CRA II and III with extensive monitoring experience are required to be responsible to achieve project goals and assist junior CRA in skill and professional development..CRA II and III will display the leadership capabilities to a certain extent and be able to handle complex situation, and to take mentor role with CRA I or new comer when needed.

Key Responsibilities

Operational Conduct of Clinical Studies

Pre-study Activities

  • Assist Study Manager and sponsor representatives to sites and investigators identification and selection, including site feasibilities
  • Assist Study Manager and sponsor representatives with preparation of study budget
  • Prepare documentation for Ethics Committee submission and HGRAC application
  • Coordinate receipt and distribution of clinical trial supplies
  • Identify and source study supplies.
  • Liaise with investigators and site staff regularly to ensure effective initiation of studies
  • Develop appropriate monitoring tools
  • Support Sponsor& Project Leader to organize investigator meetings within budget.
  • Site Monitoring Activities

  • Prepare and conduct initiation visits according to Study Monitoring Plan.
  • Oversee assigned clinical trials to ensure compliance with ICH-GCP guidance, local regulation, and the SOPs of Sponsor and /or dMed
  • Monitor and document the progress of assigned clinical studies through regular visits and telephone contact with site personnel following with Study Monitoring Plan
  • Liaise with Project Leader regularly on study status through monitoring reports and meetings
  • Liaise with other CRAs on study progress to maintain consistency if working on the same study.
  • Document all study related communications.
  • Perform Source Data Verification to ensure accurate data is recorded.
  • Ensure all Serious Adverse Events are reported timely and followed up according to Sponsor and/or dMed SOPs.
  • Maintain drug accountability of all clinical supplies and arrange for destruction as per specified clinical study.
  • Ensure study documentation for each clinical trial is complete and returned to Sponsor or dMed in accordance with set schedules.
  • Ensure documentation is maintained according to Sponsor or dMed SOPs.
  • Track study payments to ensure payments are on time and within budget.
  • Coordinate the resolution of data queries within a required timeframe.
  • Perform study closeout visits at the completion of database lock.
  • Support & coordinate with site to achieve site master files to ensure the competence and also to meet the requirements of site GCP office.
  • Review study reports when required.
  • Reporting

  • Accurate completion of Monitoring visit reports with the required timeframe.
  • Ensure regular updating of trial tracking systems or templates.
  • Prepare study progress reports for Project Leader/Sponsor by specified dates, which is copied to line manager

  • Personal Development
  • Complete the dMed monitoring training program within the set timeframe.
  • Complete the dMed Safety Reporting Process: Overview training module in the set timeframe.
  • Attend and actively participate in personal development courses as required.
  • Attend training in specific therapeutic or clinical research areas as required.
  • Participate in TA knowledge, disease/indication training from dMed internal other functional lines as required

  • Education and Key Competency Requirement
    Professional Experience & Education Requirement

  • Minimum Medical or pharmaceutical education background or other life science degrees (or equivalent); clinic practice is preferred
  • With 2 years of experience in clinical trials preferred
  • Good working knowledge of GCP guidelines.
  • Proficiency in Basic Microsoft Word and Excel and familiarity with use of database
  • Knowledge of drug development process.

  • Key Competency Requirement

  • Organizational commitment and result Oriented
  • Customer orientation and service mindset
  • Self-awareness and self-motivated
  • Well-developed of communication (Chinese & English), presentation, and interpersonal skills
  • Teamwork and collaborative working attitude
  • Able to plan, organize and prioritize various types of work and projects efficiently
  • Project management skills to deliver key milestones with high quality
  • Capability to identify issue and solve problems effectively and proactively
  • Resilient to changing project requirement or business needs with proactive approach
  • Continuously learn new knowledge and skills to keep up-to-date technical and disease area knowledge Ability to travel as needed
  • Apply for the position
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