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 (CRA I & II & and Sr. CRA) of responsibility accorded to a CRA will reflect their level of experience and contribution that they can make to the project.
CRA II and Sr. CRA 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.
Operational Conduct of Clinical Studies
一. Pre-study Activities
1. Assist Study Manager and sponsor representatives to sites and investigators identification and selection, including site feasibilities.
2. Assist Study Manager and sponsor representatives with preparation of study budget.
3. Prepare documentation for Ethics Committee submission and HGRAC application.
4. Coordinate receipt and distribution of clinical trial supplies.
5. Ensure required documents ready for site initiation process.
6. Liaise with investigators and site staff regularly to ensure effective initiation of studies.
7. Develop appropriate monitoring tools
8. Support Sponsor& Study Manager to organize investigator meetings within budget.
二. Site Monitoring Activities
1. Prepare and conduct initiation visits according to Study Monitoring Plan.
2. Oversee assigned clinical trials to ensure compliance with ICH-GCP guidance, local regulation, and the SOPs of Sponsor and /or dMed.
3. Monitor and document the progress of assigned clinical studies through regular visits and telephone contact with site personnel following with Study Monitoring Plan.
3. Liaise with Study Manager regularly on study status through monitoring reports and meetings.
4. Liaise with other CRAs on study progress to maintain consistency if working on the same study.
5. Document all study related communications in a timely manner.
6. Perform Source Data Verification to ensure accurate data is recorded in a timely manner.
7. Ensure all Serious Adverse Events are reported timely and followed up according to regulatory requirements, Sponsor and/or dMed SOPs.
8. Maintain drug accountability of all clinical supplies and arrange for destruction as per specified clinical study.
1. Accurate completion of Monitoring visit reports with the required timeframe and ensure all issues are correctly identified and categorized.
2. Ensure regular updating of trial management systems.
3. Prepare study progress reports for Study Manager /Sponsor by specified dates, which is copied to manager of site manageme.
4. Ensure all significant quality issues identified in the site are reported per Sponsor/dMed SOP requirement.
Professional Experience & Education Requirement
1. Minimum Medical or pharmaceutical education background or other life science degrees (or equivalent); clinic practice is preferred.
2. With 2 years of experience in clinical trials preferred.
3. Good working knowledge of GCP guidelines.
4. Proficiency in Basic Microsoft Word and Excel and familiarity with use of database.
5. Knowledge of drug development process.
6. Organizational commitment and result Oriented.
7. Customer orientation and service mindset.
8. Self-awareness and self-motivated.
9. Well-developed of communication (Chinese & English), presentation, and interpersonal skills.
10. Ability to travel as needed.
备注： ‘职位月薪’ 仅供参考，具体薪资和福利将根据候选人经验和能力综合评定。