Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.

Clinical Research Associate II

Your tasks and responsibilities


 1. All aspects of site management and monitoring activities for
 assigned applicable Phase I and all Phase II-IV clinical Investigator
 sites within the approved Clinical Development Plan (CDP). These
 global, complex studies are conducted within the standards set by Bayer
 Global Development, according to Good Clinical Practices (ICH - GCP)
 and applicable regulatory and legal requirements.
 2. Managing Investigator site and site activities and monitoring site
 data, to ensure patient safety and ethical and regulatory compliance
 necessary to provide quality data required for global regulatory
 submissions for approval of drugs.
 3. Managing Investigator sites to ensure the Investigator and Site
 Staff meetall aspects of study delivery and commitments to make
 certain the operational study execution is on track from site selection
 to site close out.
     a. Conducting Site Selection Visits to confirm the Investigator and
 Site Staff are qualified,and have suitable resources and facilities to
 properly conduct the study.
      b. Ensuring completion of site documents necessary for ethics and
 regulatory approval for site initiation within agreed upon timelines.
 Ensuring all legal, regulatory and Bayer requirements are met prior to
 drug shipment to sites as well as all site initiation processes are
 completed.
      c. Ensuring Investigator Agreements and budgets are negotiated and
 executed for assigned study sites, and subsequently initiating payments
 at key milestones.
      d. Training and supervising cross functional site personnel on
 study related procedures for the duration of the study.
      e. Continuously assessing site performance, processes,

Who you are

 adherence to study protocol, Bayer Healthcare requirements, regulatory
 and local legal requirements, as well as ICH-GCP.
      f. Tracking to ensure sufficient resources at site to conduct
 study activities for duration of the study.
      g. Tracking enrollment activities to ensure site remains on track
 with site commitments. Develops contingency plans to ensure site
 commitments are met.
      h. Reviewing patient data at site to ensure safety of patient and
 patient data is consistent with what is reported in the case report
 form. Serves as liaison between Investigator and Study Medical Expert
 to resolve any medical patient-related queries. The data from these
 clinical sites are required to demonstrate patient safety and efficacy
 of investigational products which forms the basis of regulatory
 approval.
       i. Assuring adequate control of investigational product (study
 medication), which includes: ensuring sites have met all local and
 legal requirements to receive investigational product, study drug
 storage, and continually ensuring patient compliance with expected
 study drug dosing. The CRA II is responsible for study drug
 accountability at the site level and arranges for destruction of
 investigational product in accordance with local legal and regulatory
 requirements.
      j. Ensuring applicable authorities are notified of study closure
 and final patient status in accordance with ICHand local regulations.
      k. Periodically reviews Investigator Site File to ensure essential
 documents are maintained according to ICH and SOP requirements.
 4. Rigorous regul

Your application

Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.

Country: China
Location: BeiJing

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Last update: Dec 7, 2018   Copyright © Bayer AG
URL: https://career.bayer.cn/opencms/opencms/job/Clinical-Research-Associate-II--SF31261.html