liujian0806 / 待分类 / 超实用,CRA、CRC英文简历“金句”分享!




2017-05-23  liujian08...


Clinical Research Associate

  • Lead monitor (CRA) mentoring and supervising other monitor(s).

  • Assist in investigator study site selection and study start-up.

  • Create clinical project documents according to the protocol, including, but not limited to, source documentation forms and guidelines, monitoring Standard Operating Procedures (SOPs), monitoring visit templates and reports.

  • Implement and monitor clinical trial to ensure sponsor/investigator obligations are met and are compliant with applicable local requirements and CFDA and GCP guidelines.

  • Conduct monitoring visits to confirm protocol compliance, assess qualifications of study personnel, ensure “Good Clinical Practice”, and conduct close-out visits.

  • Identify site issues and initiates correction plans based on monitoring reports.

  • Perform investigative site file reconciliation: requests any new and updated site-related essential and non-essential documents and reviews them for content, consistency with other documents, and compliance with appropriate local regulatory requirements,project Standard Operating Procedures (SOPs), and sponsor requirements.

  • Verify data in source documents are in agreement with source, initiate data query resolution and confirm resolution in timely manner.

  • Ensure subject safety and adverse event reporting to sponsor and EC.

  • Verify drug accountability logs and storage requirements.

  • Responds to requests from investigative sites in a timely fashion.

  • Provide study status updates to team members and project management, including interaction to resolve site issues and facilitate project timelines.

Clinical Research Coordinator

  • Assist with the preparation of EC applications, including protocol and informed consents and obtain approval to conduct the study.

  • Maintain appropriate correspondence with the EC, including adverse events, annual renewals and protocol amendments.

  • Conduct telephone interviews to determine subject eligibility. Schedule intake appointment to recruit subjects to study.

  • Maintain source documents and regulatory documentation of clinical trial. Ensure quality of data on CRFs.

  • Monitor health and safety of subjects with frequent contact and ensure subject compliance with the study protocol.

  • Present adverse event documentation to Principal Investigator and sponsor where appropriate.

  • Prepares documents for review by sponsors, monitors and regulatory authorities, as necessary

  • Proficiently attending sponsor's activities such as trainings, meetings, teleconferences, etc.

  • Expertise on timely recording and documenting trials: Case Report Forms completion and electronic data entry. 

  • Disposition to follow GCP and SOP when conducting assigned studies. 

  • Excellent organization of study documentation. 

  • Diligence on scheduling and/or coordinating initiation visits, site visits, audits, monitoring visits, closing monitoring visits; scheduling interviews, teleconferences, etc. 

  • Handling, logging and dispensing medication. 




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