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
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