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CLINICAL TRIAL SPECIALIST
Requisition ID: 1700199016W
1. Act as key contact person to support the local study teams on the preparation of HGRA submission dossier, submit the HGRA approval application and ensure the HGRA approval, sample exportation approval and CIQ approval, in line with HA related regulations and requirements.
2. Proactively negotiate with HGRAC and hospitals to ensure each permit application successful and each batch permit of trial samples to be exported successfully, per the trial plan.
3. Maintain HGRA application, approval and samples exportation related data tracking, as well as the relevant files archiving.
4. Proactively work with local study teams to collect the data, address the issues and concerns to respond the internal/external environment change, and to proactively provide the inputs on the sample exportation application process optimization and issues resolution, supported by Functional Manager, GCO Q&C and stakeholders.
5. Where applicable, provide the training and or the updates on the sample exportation related regulations/process to the dept. and cross functions.
6. Act as Liaise with Finance teams, Legal, HCC, Procurement, C&G, GCO Q&C, and other stakeholders to obtain guidance and escalate issues as appropriate.
7. May act as SME member, proactively contribute to the process improvement including responsible functional areas, but not limited, in process initiatives and contribute to optimization of daily processes.
8. May act as ARIBA Super user to submit the request of PO setup, and follow up the PO related issues resolution with the stakeholders Finance, HCC etc.
9. May act as Local Archiving Coordinator to coordinate the management of Department/Trial related files archiving, input on the local archiving SOP/WI updates, supported by Functional Manager, GCO Q&C, and other stakeholders.
10. May act as Trial Supply Coordinator to coordinate the management of trial supplies, proactively provide the inputs on the supply process optimization, issues address and resolution, with the support of Functional Manager, Procurement, Legal and other stakeholders.
11. May act as Contracting Coordinator to collect the data, address the issues and concerns to respond the internal/external environment change, proactively provide the inputs on the contracting cycle time shortening process optimization and issues resolution, supported by Functional Manager and stakeholders.
12. Comply with requests from QA and auditors.
13. Partners with the LTM and Site Manager to ensure overall site management and adherence to internal SOPs, policies and local regulatory requirements.
14. 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.
15. 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.
16. Supports the LTM or, where applicable the SM, in providing the current and complete documents requested by the IEC/IRB and HA.
17. Supports the SM/LTM in collecting and maintaining all documents throughout the trial and post-trial in both vTMF (i.e., IF/LAF sections) and paper files.
18. Distributes, collect, review, and track regulatory documents, agreements and training documentation.
19. May be assigned as a coach and mentor to a less experienced CTA.
20. Complies with relevant training requirements.
A minimum of a BA/BS degree is preferred. Skills set corresponding with preferentially 4+ years’ relevant clinical trial experience or equivalent. Proficient in English language. Strong knowledge with MS Office (Word, Excel, Access, Outlook, Explorer and PowerPoint), Strong interpersonal and negotiating skills. Excellent organizational skills and the ability to collaborate and handle multiple priorities within a matrix environment. Perform activities in a timely and accurate manner. Proficient in the English language.
J&J (China) Investments Ltd A- Beijing Branch (7075)
Clinical Trial Administration