[존슨앤드존슨] [Janssen] Global Trial Associate

 [Janssen] Global Trial Associate

[담당업무]

1. Provide administrative and logistical support to Clinical Trial Assistant (CTAs), SM and/or LTM in tracking progress of the trial, management of study data, budget, organizing meetings, mailing and correspondence, materials, drug distribution and other relevant tasks as appropriate in adherence to relevant SOPs, policies, and local regulatory requirements.

2. Support the local study team in performing site feasibility and/or country feasibility. Collaborates with the Global Project Team, e.g. Clinical Trial Manager (CTM)/Global Trial Lead (GTL), local management/Country Head and other study team members, as required.

3. Maintain information in relevant systems, including electronic filing (electronic Trial Master File: eTMF).

4. Ensure current versions of the required trial documents, trial-related materials and supplies are provided to the investigational site within required timeframes, as applicable.

5. Support CTA, SM and/or LTM in collecting/preparing documents required for study start-up/ submission to Ethics Committee/IRB and/or Health Authorities.

6. Support CTA SM and/or LTM in collecting, processing, and archiving study related documents as appropriate. Use appropriate systems to ensure file completeness at designated study milestones.

7. May assist team in conducting local investigator meeting or with planning for the investigators participating in an international meeting.

8. Maintain and update contact information in relevant systems to ensure appropriate safety updates distribution.

9. Comply with all training requirements, company policies & procedures and all applicable laws and regulations. Always act aligned with J&J Credo.

10. Ensure inspection readiness at all times.

11. May contribute to process improvement.

12. Support SM and within a reasonable timeframe be able to take on responsibility in executing activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/ study close-out according to Standard Operating Procedures, Work Instructions (WIs) and policies.

[접수기간]

01월 22일 ~ 02월 11일

[채용공고]