Main responsibility

Planning, performing, management, coordinating for clinical research, targeting local regulatory approval, international clinical research and/or marketing support, according to GCP, SOP and BHC strategy.

Principal Accountabilities
Describe the major functions or activities that your job performs.

1. Study Preparation: To support study manager or S.CRA to prepare clinical trial, including study contracts development, study medication order, selecting potential investigator/site, developing protocol/ICF/ CRF, maintain filling system, according to Bayer’s strategy & timeline;
2. Site monitoring and management: To initiate, monitor and close-out sites ensuring their proper conduct according to relevant guideline, Bayer SOP, ICH-GCP and to ensure that data collected are an accurate representation of the facts (approximately 85% of the CRA’s time should be spent on monitoring). To set study commitments in association with the Study Manager and operate within them.
3. Information release: Periodically report/update any study specific tracking systems of sites and  update IMPACT database for responsible sites.
4. External Supplier Management: To support study managers or S.CRA to manage and negotiate with external service providers.
5. Training Participation: To join or aid in the training of Bayer and contract monitoring staff.
6. Customer Maintain: Keep positive relationship with unit principle investigators  and investigators.