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制作英文简历的时候，98%的CRA、CRC应该都会遇到不知如何用正宗的英文来描述自己的工作内容，以下是小编精心整理的CRA和CRC相关“金句”，供大家参考、收藏使用！
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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