北京诺华制药有限公司制药工厂Clinical Research Associate

Clinical Research Associate
非销售职位
工作地点：北京

Working Area / City: Beijing

Job Description:

Participates in the identification of potential investigators and clinical sites conducts pre-study site visits, collects and reviews data, and prepares evaluative reports; participates in the final selection of investigators and study sites.

Participates in negotiating site/investigator grant within trial specific budget

Conducts clinical site initiation visits; advises and trains site personnel on Novartis internal and regulatory requirements for clinical trial conduct; participates and/or conducts site meetings

Verifies that the investigator has adequate qualifications and resources and remain adequate throughout the trial period.

Verifies that site facilities, including laboratories and equipment, and staff, are adequate to safely and properly conduct the trial and remain adequate throughout the trial period.

Responsible for trial materials distribution and accountability

Monitors and reports trial progress and ensures timely subject recruitment and trial completion.

Conducts site monitoring visits and follow-up to ensure that all clinical aspects of studies are being carried out in accordance with the protocol, regulatory requirements, GCP guidelines and SOPs.

Identifies trial site problems and initiates/implements corrective actions.

Ensures high quality CRF completion in a timely manner and performs source data verification

Ensures that the receipt, use and return of the investigational product(s) at the trial sites are controlled and documented adequately

Performs trial document management and ensures both trial / site specified TMFs and Investigator Folders are completed according to ICH GCP and internal SOPs/NIPs.

Ensures all SAEs are appropriately reported within the time frame required by GCP, the protocol and the SOPs.

Complete a written monitoring visit report after each trial-site visit or trial related communication. Report should include a summary of what the monitor reviewed and the monitor's statements concerning the significant findings/facts, deviations and deficiencies, conclusions, actions taken or to be taken and/or actions recommended to secure compliance.

Performs IMPACT data entry in a timely manner.

Ensures the investigator payment are processed according to study site budget plan and clinical trial agreement with the investigator.

Performs miscellaneous job-related duties as assigned.
Requirement:

Bachelor's degree in the fields of Clinical Medicine or Healthcare Sciences plus minimum 2 years of working experience or post-graduate education.

Completion of Novartis internal formal CRA training.

Thorough understanding of the international aspects of drug development process.

Knowledge of ICH GCP and understanding of national regulations essential

Knowledge of randomized controlled clinical trial principles, methodology, and procedures.

Good self-motivation and self-organization

Good interpersonal skills, diplomacy and the ability to motivate and organize other

Fluency in both verbal and written English essential

Computer literacy essential





For more information please visit www.novartis.com.cn or www.pharma-novartis.com.cn

Please send your CV (in both Chinese and English) through either:

Post:
No.31, Yong'an Road, Changping County, Beijing, 102200, China
Beijing Novartis Pharma Ltd.(Please mark job ID in the envelop).
  
Fax：
(010)69744887

E-mail：
recruit_hr.phcnbj@pharma.novartis.com