Job Overview:
Clinical Research Associate performs site management, site administration and site monitoring responsibility for clinical studies according to Covance Standard Operating Procedures, ICH Guidelines and GCP, including pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.
Responsibilities and duties include, but are not limited to the following:

• Take charge of all aspects of Site Management as prescribed in the project plans.
• Recruit potential investigators, prepare EC submissions, notify regulatory authorities, translate study-related documentation, and organize meetings and other tasks as instructed by supervisor.
• Negotiate study budgets with potential investigators and collaborate with the Covance legal department with statements of agreements as assigned.
• Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
• Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management.
• Assist with training, mentoring, and development of new employees, e.g. co-monitoring.
• Perform other duties as assigned by management. Education/Qualifications:

【Education/Qualifications】

• University/college degree (life science preferred), or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing certification, medical or laboratory technology). Experience:

【Experience】

• Full experience in PSV, SIV, RMV, COV in chemical drug, phase II/III.
• At least 1 year CRA experience for CRA I.
• At least 1.5 year global CRA experience or above 2 years CRA experience for CRA II.
• Oncology study experience is highly preferred.
• Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines.
• Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.
• English workable is a MUST.