FSP-CRA (Beijing)

6 days ago

Beijing, Beijing, China 深圳市启睿科技有限公司 Full time CN¥120,000 - CN¥240,000 per year

该职位来源于猎聘 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. Responsibilities and duties include, but are not limited to the following:

  • Take charge of all aspects of Site Management as prescribed in the project plans.
  • Recruit potential investigators, prepare EC submissions, notify regulatory authorities, translate study-related documentation, and organize meetings and other tasks as instructed by supervisor.
  • Negotiate study budgets with potential investigators and collaborate with the Fortrera legal department with statements of agreements as assigned.
  • Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
  • Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management.
  • Assist with training, mentoring, and development of new employees, e.g. co-monitoring.
  • Perform other duties as assigned by management. 【Education/Qualifications】
  • University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology). 【Experience】
  • Full experience in PSV, SIV, RMV, COV in chemical drug, phase II/III.
  • 1~3 years CRA experience for CRA I. For reference only
  • 2~4 years CRA experience for CRA II. For reference only
  • At least 4 years CRA experience for SCRA. For reference only
  • Oncology study experience is highly preferred.
  • Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines.
  • Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
  • English workable is a MUST.

  • Mgr, FSP 360

    6 days ago

    Beijing, Beijing, China Syneos Health Full time CN¥120,000 - CN¥240,000 per year

    DescriptionMgr, FSP 360 - BeijingSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient to the center of...

  • Syneos Mgr, FSP 360 临床试验人员管理经理

    6 days ago

    Beijing, Beijing, China 赛纽仕医药咨询(上海)有限公司 Full time CN¥400,000 - CN¥550,000 per year

    该职位来源于猎聘 Position: Manager, FSP 360 (既CRA直线经理) Location: Syneos Health Beijing office based职责描述: JOB SUMMARY Accountable for and provides management support and direct supervision to Clinical Operations staff in the assigned area.Provides training, consultation and oversees metric compliance and quality related to operating...

  • CRA II

    4 days ago

    Beijing, Beijing, China Syneos Health Full time

    DescriptionCRA II - BeijingSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient to the center of...

  • scra

    6 days ago

    Beijing, Beijing, China ICON Strategic Solutions Full time CN¥100,000 - CN¥120,000 per year

    Senior Clinical Research Associate, Beijing, Office baseICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.We are currently seeking a Senior Clinical...

  • Scra

    6 days ago

    Beijing, Beijing, China IRE Full time CN¥120,000 - CN¥180,000 per year

    Senior Clinical Research Associate, Beijing, Office baseICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical developmentWe are currently seeking a Senior Clinical...

  • Mgr, FSP 360

    6 days ago

    CHN-Beijing, China Syneos Health Full time CN¥120,000 - CN¥240,000 per year

    Mgr, FSP 360 - BeijingSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.  Our Clinical Development model brings the customer and the patient to the center of...