(Sr.)Clinical Trial Operation Specialist
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Job Location:
Monthly Salary:
Posted on:
12 hours ago
Vacancies:
1 Vacancy
Job Summary
JOB DESCRIPTION:
Primary Function
职责概述
To response for regulatory clinical trial and be a key initiator of related activities to ensure the clinical trials are conducted on time and operation in compliance.
Major Responsibilities
主要职责
- To support manager to coordinate new sites for clinical trials; Evaluate new site capability and compliance.
- To manage the clinical trial site database. Collect and analyze the clinical trial procedures IRB documents IRB/EC frequency contract information; Monitor on line of clinical trial.
- Coordinate and manage the locked sites to ensure the clinical trial operation in unique protocol and standard.
- Draft clinical trial protocol to meet the regulatory regulation and guideline. Adjust the supplementary requirement of authorization agency on clinical trial.
- Coach the CT persons and actualize the CT operation when necessary.
- Response the CT sample management and adjustment.
- To make order for clinical trial assays and coordinate with supply chain to ensure the on-time shipment. Original document and data management and archive.
- Explain to evaluation expert if necessary. Monitor on line of clinical trial.
- Receive clinical trial regulation and GCP training.
- Must deal with the self-inspection prepare for the on-site inspection and its related document preparation. To ensure all steps are on-time included but not limited the IRB approval contracts filing sample collection and testing signature and stamp etc. To ensure the feasibility and quality of clinical trial protocol.
Requirement(education backgroundetc)
要求
- Bachelor or above
- Background is with Clinical Laboratory immunology clinical medicine or related specialty.
- Minimum 3 to 5 years Clinical trial experience technical support or registration experience of IVD is preferred.
- Skills on English listen speak writing.
- Experienced on statistical software is preferred.
- Expertise in communication managing multiple priorities and computer literacy.
- Knowledge and experience in international standards (ICH/GCP) and local regulations;
- Global study experience is preferred.
- Prefer to MNC working or internship experiences.
The base pay for this position is
N/AIn specific locations the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
CRLB Core Lab
LOCATION:
China > Beijing : Canway Building
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
Required Experience:
Senior IC
Key Skills
- Computer Science
- Business Process
- SQL
- Active Directory
- VMware
- Data Entry
- Clearance
- OS
- Windows
- System Issues
- Linux
- Sharepoint
- Backup
- hardware
- Technical Support
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
