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**Job Function: **
R&D Operations
**Job Sub Function: **
Clinical Trial Support
Job Category:
Professional
All Job Posting Locations:
Shanghai, China
Job Description:
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.
This is not an exhaustive, comprehensive listing of job functions. May perform other duties as
assigned.
**Required Skills: **
Preferred Skills:
Analytical Reasoning, Business Behavior, Business English, Clinical Data Management, Clinical Trials, Clinical Trials Operations, Execution Focus, Issue Escalation, Laboratory Operations, Process Improvements, Process Oriented, Project Support, Regulatory Environment, Research and Development, Research Ethics, Study Management, Time Management