Are you a Clinical Research Associate who wants to work with one ofleading global CROs in the industry? Covance is seeking CRAs with atleast 1 year clinical monitoring experience NATIONWIDE, and has avariety of CRA needs in Phase II-IV and Phase I (Early ClinicalDevelopment) in multiple therapeutic areas such as oncology,cardiovascular, diabetes mellitus, endocrinology, etc. Whether you’reready to make a move or just interested in learning more, apply TODAYand let’s talk together!
Covance China is committed to providing a clinical research career withpurpose in a culture that values achievement. By joining our ClinicalTrial Operations Team, you will work in a collaborative environment withthe flexibility to pursue different clinical trials involving variouscompounds - giving you an excellent overview of best practices acrossthe industry. Experience the global reach and therapeutic record ofsuccess from one of the few truly global drug development companiespositioned to provide comprehensive clinical support from First-in-Humanstudies.
Responsibilities/Duties:
Clinical Research Associate performs site management, siteadministration and site monitoring responsibility for clinical studiesaccording to Covance Standard Operating Procedures, ICH Guidelines andGCP, including pre-study qualification and initiation visits, routinemonitoring, close-out of clinical sites, and maintenance of study files.
Responsibilities and duties include, but are not limited to thefollowing:
• Take charge of all aspects of Site Management as prescribed in theproject plans.
• Recruit potential investigators, prepare EC submissions, notifyregulatory authorities, translate study-related documentation, andorganize meetings and other tasks as instructed by supervisor.
• Negotiate study budgets with potential investigators and collaboratewith the Covance legal department with statements of agreements asassigned.
• Complete Serious Adverse Event (SAE) reporting, process production ofreports, narratives and follow up of SAEs.
• Independently perform CRF review; query generation and resolutionagainst established data review guidelines on Covance or client datamanagement 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:
• University/college degree (life science preferred), or certificationin a related allied health profession from an appropriately accreditedinstitution (e.g., nursing certification, medical or laboratorytechnology).
Experience:
In lieu of the above requirement, candidates with three or more years ofrelevant clinical research experience in pharmaceutical or CROindustries will be considered.
• Ability to monitor study sites independently according to protocolmonitoring 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 ofSAEs.
• CRA II positions require 2+ years of clinical research monitoringexperience
• Senior CRA positions require 4+ years of clinical research monitoringexperience. Alternatively candidates with 4+ years supervisoryexperience in a health care setting and 3+ years clinical researchexperience in the pharmaceutical or CRO industries (includingmonitoring) may also be considered.
Preferred:
One or more additional years of experience in a related field (i.e.medical, clinical, pharmaceutical, laboratory, research, data analysis,data management or technical writing) is preferred. More years ofexperience preferred if apply senior level CRA positions.
About Covance:
Covance is one of the world’s largest and most comprehensive drugdevelopment services companies, with more than 11,000 employees in 60countries. We began operations in Asia Pacific in 1988 and today havemore than 1000 employees in 14 countries across the region. Through ourdiscovery, nonclinical, clinical and commercialization services, Covancehas helped pharmaceutical and biotech companies develop one-third of allprescription medicines in the market today.
Why Covance China?
At Covance China, you will join like-minded professionals who, together,build our reputation as one of the world's largest and most respectedcontract research organizations. In choosing Covance China, you will bepart of a dedicated team that makes a difference in helping to deliverlife-saving and life-enhancing medicines to people around the world.
We Offer
Covance’s ongoing success offers team members unsurpassed growth andcareer development opportunities. At Covance China, we help make themiracles of medicine a reality. We offer opportunities to work ondiverse, challenging projects with bright, interesting colleagues whilebuilding a flexible and rewarding career.
There is no better time and choice to join us!
