浏览原职位详情
- 职位介绍
- 1. Partners with the LTM and Site Manager to ensure overall site management and adherence to internal SOPs, policies and local regulatory requirements. 2. Supports the local study team in performing site feasibility and/or country feasibility. 3. Maintains site level protocol information in Trial Management Systems (e.g. CTMS). 4. In liaison with the LTM, ensures current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes. 5. Where applicable, works with investigational site staff to ensure accurate/complete regulatory documents are in place to expedite IEC/IRB or Health Authority (if applicable) approval process. 6. Supports the LTM or, where applicable the SM, in providing the current and complete documents requested by the IEC/IRB and HA. 7. Supports the SM/LTM in collecting and maintaining all documents throughout the trial and post-trial in both eTMF (i.e., IF/LAF sections) and paper files. 8. Distributes, collect, review, and track regulatory documents, agreements and training documentation. 9. Collects and tracks Financial Disclosure information at appropriate time points. 10. Complies with relevant training requirements. 11. Region specific (to be specified) a. Negotiates site requested changes to the Confidential Disclosure Agreement; checks investigators and IEC/IRBs against exclusion databases, IEC/IRB registrations. Alerts LTM of any findings. b. Prepares Trial Center File and prepare or co-ordinate the development of any other document and review them for completeness and accuracy. c. Assist the LTM in conducting local investigator meeting or in making arrangements for the investigators participating in an international meeting. d. May be assigned to assist in document review for outsourced trials. e. Support the LTM in drug distribution process. f. Provide administrative and logistical support to the LTM/SM in tracking progress of the trial, management of study data, budget, organizing meetings, mailing and correspondence and other relevant tasks as appropriate g. Supports the LTM (e.g., in US) in compiling the List of Investigators for CSR (Appendix 1.4.1) is accurate and complete. h. Maintains and updates CTSRS contact information to ensure appropriate SUA distribution and if applicable disseminates SUA packet. i. Maintains and transmits ERIS Transmittal Summary of 1572 and PI CV to Regulatory Affairs for NDA submission. j. Archives off-site paper Trial Master File. k. Supports the LTM in compiling accurate/complete regulatory documents for submission to Health Authority at country level. l. Upon request from LTM, reviews site specific Informed Consent Form (ICF) for completeness to facilitate the approval of changes to mandated J&J language in collaboration with legal department, and if applicable, Contract and Grants Associate.
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