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Post name:

Clinical Trial Assistant

Salary:
Based upon experience
Work location:
Boston USA
Department:
Clinical Department
Position:
1
Job nature:
Full time
Work related experience:
5-10 years
Education:
Regular college
Post date:
2021/08/15
Page view :
Post description:

Responsibilities:

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.

Requirements:

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.