Senior Clinical Research Associate

Major Responsibilities：

• All aspects of site management and monitoring activities foe 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.
• Managing Investigation site and site activities and monitoring site data, to ensure patient safety and ethical and regulatory compliance necessary to provide data required for global regulatory submissions for approval of drugs.
• Managing Investigator sites to ensure the Investigator and Site Staff meet all aspects of study delivery and commitments to make certain the operational study execution is on track from site selection to site close out.
• Conducting Site Selection Visits to confirm the Investigator and Site Staff are qualified, and have suitable resources and facilities to properly conduct the study.
• 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 initiation processes are completed.
• Ensuring Investigator Agreements and budgets are negotiated and executed for assigned study sites, and subsequently initiating payments at key milestones.
• Training and supervising cross functional site personnel on study related procedures for the duration of the study.
• Continuously assessing site performance, processes, qualifications of staff, and suitability of facilities to ensure adherence to study protocol, Bayer Healthcare requirements, regulatory and local legal requirements, as well as ICH-GCP.
• Tacking to ensure sufficient resources at site to conduct study activities for duration of the study.
• Tracking enrollment activities to ensure site remains on track with site commitments. Develops contingency plans to ensure site commitments are met.
• Reviewing patient data at site to ensure safety of 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.
• Assuring adequate control of investigational product(study medication), which included: 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 Sr. CRA 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.
• Ensuring applicable authorities are notified of study closure and final patient status in accordance with ICH and local regulations.
• Periodically reviews Investigator Site File to ensure essential documents are maintained according to ICH and SOP requirements.
• Rigorous regulatory guidelines exist to ensure overall patient safety related to reporting of serious or unexpected adverse drug timely reporting and as well as monitoring ongoing compliance. Strict adherence is essential to remain compliant with on time reporting from Bayer to regulated clinical trial environment, the Sr. CRAs ensures timely and sufficient resolution of issues that may impact compliance or quality of study related activities or data.
• Due to the highly regulated clinical trial environment, the Sr. CRA proactively identifies potential issues and develops site Corrective Actions / Preventive Actions(CAPs) Plans, the Sr. CRAs ensures timely and sufficient resolution of issues that may impact compliance or quality of study related activities or data.
• As key contributor to the Trial Master File and study documents at the country level, ensures essential documents are appropriate and filed in a timely manner in the Investigator Site File.
• Incumbent is a key contributor in the preparation, conduct and follow up of Site Audits and Regulatory Inspections to ensure a successful outcome. The Sr. CRA may be a mentor and rote model for new or less experienced CRAs on process, study, technical or behavioral competencies. The Sr. CRA may also conduct co-monitoring visits as defined in the Study Oversight Plan to mitigate risks and ensure the quality and reliability of study data and processes. In addition, the Sr. CRA may participate in Expert Working Groups for Global SOPs, training or process improvement initiatives.

Requirement：

• Bachelor’s Degree (or equivalent)
• At least 4 years of monitoring & site management work experience
• In-depth knowledge of the drug development process including monitoring and site management, local and international regulations, ICH-GCP, drug safety requirements, data management processes and investigator grant parameters.
• Strong awareness and understanding of cultural communication skills, strong oral presentation, interpersonal, decision-making and issue resolution skills are required.
• Good planning and organization skills, attention to detail and excellent follow through.