職位描述
藥品臨床監(jiān)查新藥化學藥GCP藥品試驗監(jiān)查Ⅲ期Ⅱ期
Clinical Research Associate performs site management, site administration and site monitoring responsibility for clinical studies according to Fortrea Standard Operating Procedures, ICH Guidelines and GCP, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.
General On-Site Monitoring Responsibilities:
1. Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
2. Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
3. Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data.
4. Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy.
5. Prepare accurate and timely trip reports.
6. Manage small projects under direction of a Project Manager/Director as assigned.
7. Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans as assigned.
8. Review progress of projects and initiate appropriate actions to achieve target objectives.
9. Organize and make presentations at Investigator Meetings.
10. Report, write narratives and follow-up on serious adverse experiences.
11. Participate in the development of protocols and Case Report Forms as assigned.
General On-Site Monitoring Responsibilities:
1. Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
2. Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements.
3. Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review. Monitor data for missing or implausible data.
4. Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Fortrea travel policy.
5. Prepare accurate and timely trip reports.
6. Manage small projects under direction of a Project Manager/Director as assigned.
7. Serve as lead monitor for a protocol or project and may assist in establishing monitoring plans as assigned.
8. Review progress of projects and initiate appropriate actions to achieve target objectives.
9. Organize and make presentations at Investigator Meetings.
10. Report, write narratives and follow-up on serious adverse experiences.
11. Participate in the development of protocols and Case Report Forms as assigned.
12. Participate in writing clinical trial reports as assigned.
13. Interact with internal work groups to evaluate needs, resources and timelines.
14. Act as contact for clinical trial supplies and other suppliers (vendors) as assigned.
15. Responsible for all aspects of registry management as prescribed in the project plans.
16. Undertake feasibility work when requested - Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned.
17. Negotiate study budgets with potential investigators and assist the Fortrea legal department with statements of agreements as assigned.
18. Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
19. Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management.
20. Assist with training, mentoring and development of new employees, e.g. co-monitoring.
21. Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned.
22. Perform other duties as assigned by management
Job requirements:
1. Bachelor degree in Pharmacy, Medical or Nursing.
13. Interact with internal work groups to evaluate needs, resources and timelines.
14. Act as contact for clinical trial supplies and other suppliers (vendors) as assigned.
15. Responsible for all aspects of registry management as prescribed in the project plans.
16. Undertake feasibility work when requested - Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned.
17. Negotiate study budgets with potential investigators and assist the Fortrea legal department with statements of agreements as assigned.
18. Complete process of Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
19. Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management.
20. Assist with training, mentoring and development of new employees, e.g. co-monitoring.
21. Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned.
22. Perform other duties as assigned by management
Job requirements:
1. Bachelor degree in Pharmacy, Medical or Nursing.
2. At least 2 years CRA experience with regularly on-site monitoring experience in the past 3 months. Around 2.5~3 years CRA experience is preferred.
3. Full experience of SSV-SSU-SIV-SMV-COV is MUST.
4. Oncology study experience is preferred.
5. Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines.
6. Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
7. English workable is a MUST.
6. Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
7. English workable is a MUST.
工作地點
成都錦江區(qū)睿東中心-B座
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職位發(fā)布者
危女士/Recruiter
三日內活躍立即溝通
富啟睿醫(yī)藥研發(fā)(北京)有限公司 2023年7月1日，Fortrea正式從LabCorp拆分成為一家獨立運營并公開上市的全球CRO。Fortrea將持續(xù)專注于不斷增長的I-IV期臨床研究以及患者服務領域，擴大在腫瘤學、臨床藥理學等方向上的行業(yè)地位。繼續(xù)致力與新興生物技術公司、跨國大型醫(yī)藥公司、醫(yī)療器械和診斷公司合作，驅動生命科學的創(chuàng)新，加速變革為推動惠及患者的療法不斷砥礪前行。
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