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FSP_SSU_Guangzhou

Laboratory Corporation of America Holdings (Covance)

Tianhe District, Hong Kong, China

<p>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:</p><p></p><p>•Take charge of all aspects of Site Management as prescribed in the project plans.</p><p></p><p>•Recruit potential investigators, prepare EC submissions, notify regulatory authorities, translate study-related documentation, and organize meetings and other tasks as instructed by supervisor.</p><p></p><p>•Negotiate study budgets with potential investigators and collaborate with the Covance legal department with statements of agreements as assigned.</p><p></p><p>•Complete Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.</p><p></p><p>•Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management.</p><p></p><p>•Assist with training, mentoring, and development of new employees, e.g. co-monitoring.</p><p></p><p>•Perform other duties as assigned by management.</p><p></p><p>【Education/Qualifications】</p><p></p><p>•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).</p><p></p><p>Experience: In lieu of the above requirement, candidates with three or more years of relevant clinical research experience in pharmaceutical or CRO industries will be considered.</p><p></p><p>- Ability to monitor study sites independently according to protocol monitoring guidelines, S.O.P.s, GCP and ICH Guidelines.</p><p></p><p>- Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs.</p><p></p><p><b>Labcorp is proud to be an Equal Opportunity Employer:</b></p><p></p><p>As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.</p><p></p><p>For <span>more information about how we collect and store your personal data, please see our </span><span><a href="https://www.labcorp.com/hipaa-privacy/web-privacy-policy" target="_blank">Privacy Statement</a></span><a href="https://www.labcorp.com/hipaa-privacy/web-privacy-policy" target="_blank"><span>.</span></a><span> </span></p>

Job posted: 2022-04-01

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