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Beijing Office : Suite 2105, Building T2, Dazu Square, Beijing , China
Shanghai Office: 595 North Caoxi Road Building A Suite 6009 , Shanghai China
Boston Office: 99 Hayden Ave, Lexington, MA 02421, US
Tel: +86 010-56315466
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Clinical Trial Assistant
1 Assists the study team(s) to design, develop, and deliver the clinical study within agreed timelines.
2 Provides clinical study start up expertise and ensures identified efficient within study start-up are implemented.
3 Provides oversight of Clinical CRO activities regarding country and site-specific informed consent documentation tracking, finalization, and approval.
4 Ensures effective communication between Jacobio(US) and the Clinical CRO.
5 Assists in authoring/contributing to clinical study documents and study related plans developed by Clinical CROs and vendors. (E.g., Clinical Trial Insurance, IWRS specs, Lab Manual, Licensing Agreements etc.)
6 Provides oversight of Clinical CRO Investigator background checks.
7 Assists in oversight of vendor shipment of clinical supplies (e.g., lab kits, test machines, equipment etc.) being sent to sites prior to initiation, as necessary.
8 Provides oversight of Essential Documents for Investigational Medicine Release as per relevant SOP.
9 Reviews Clinical Monitoring Reports and correspondence related to Pre-Study and Initiation Visits and follows-up with Clinical CRO to resolve open action items.
10 Manages escalation of study related issues and communicates as appropriate with Clinical Project Manager.
11 Reviews a percentage of monitoring visit reports for oversight and escalates issues to Clinical Project Manager.
12 Assists with agenda distribution & minute taking for internal clinical study team meetings where formal documentation is needed and the Clinical CRO is not present.
1 Bachelor's degree required (Advanced degree or certification preferred but not required)
2 Minimum 2 years’ experience in a similar role (e.g., Sponsor, CRO or Clinical Study Vendor)
3 In-depth knowledge of operational start-up activities for phase I-IV clinical studies
4 Ability to work independently and take initiative.
5 Comfortable with technology and ability to learn new systems quickly.
6 Strong knowledge of MS Word, Excel, PowerPoint, and Outlook.