工作职责:
1 Good knowledge of the study protocol, therapeutic fields and study relevant procedures.
2 Perform site monitoring visits (not limited to feasibility , selection, initiation, monitoring and close out visits) in compliance with Good Clinical Practice (GCP), ICH-GCP, Local Laws & Regulations, Fosun SOPs, Protocol, Site Monitoring Plan and associated documents.
3 Conduct protocol and study related training to responsible sites and establish regular communication line with site staff to make sure project management and issues resolution as scheduled
4 Communicates with site staff on issues related to protocol conduct, recruitment, retention, protocol deviations, regulatory documentation, site audits/inspections and overall site performance. Report quality issues to the responsible PM and/or line manager.
5 Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator’s Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
6 Create and maintain appropriate documentation (clear, comprehensive and accurate) regarding site management, monitoring visit & non-visit findings and action plans by submitting regular visit reports, generating follow-up letters, contact reports and other required study documentation in a timely manner.
7 Develops strong site relationships and ensures continuity of site relationships through all phases of the trial.
8 Independently perform eCRF review; query generation and resolution against established data review guidelines or data management systems as assigned by management.
9 Representation of CRAs during an audit or inspection when assigned
10 Assist the project manager to complete sample distribution, contract payment, summary report, etc.
11 Conduct and assist with administrative activities as a member of the project team.
任职资格:
Education 学历
Bachelor degree or above in medicine related major, master's degree is preferred
Experience 工作经验
At least 0.5 year of CRA experience, or 1-2 years CRC experience
Skills and Abilities 技能和能力
1 Good knowledge of Good Clinical Practice (GCP) and understanding of applicable regulatory requirements
2 Written and verbal communication skills including fluent in local languages and good command of English language.
3 Computer skill including proficiency in use of Microsoft word, Excel, etc.
4 Organizational and problem solving skills.
5 86 Effective time and financial management skills.