職位描述
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職位職能:
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職位描述:
Job Responsibilities:
·
Oversees the progress of clinical studies, ensuring that they are conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP) and the applicable Regulatory requirements.
· Establishes regular lines of communication with clinical study sites to manage ongoing project expectations and issues.
· Get ethical approval, study agreement signed and study reported finished.
· Identifies and screens potential study sites and investigators for inclusion into investigational site pool
· Serves as the interface to physicians, laboratorians and key opinion leaders.
· Conduct on-site monitoring visits in accordance with Good Clinical Practices, ICH guidelines and standard operating procedures.
· Assists in the review of clinical data and generation of study reports for regulatory submission.
Requirements:
·Bachelors or Masters Degree in the Biological Sciences or Medical discipline
·Minimum 2 years of clinical research experience including demonstrated competency in site monitoring (including pre-study, initiation, routine monitoring and closeout visits).
IVD study experience strongly preferred.
· Good knowledge of medical device/IVD development processes, clinical trial monitoring procedures, medical terminology and GCP/ICH guidelines
· Excellent organizational, teamwork and problem solving skills and communication skills
· Familiar with statistical analysis
· Willingness to travel
· Good computer skills.
· Fluent in local office language and in English, both written and verbal.
