Covance is seeking a CRA to cover the Northeast and West Coast region of the US. This is a specialized CRA role which primarily focuses on drug accountability at a site level across a range of protocols and therapeutic areas.
Essential Job Duties:
Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits; liaise with vendors; and other duties, as assigned
Responsible for all aspects of site management as prescribed in the project plans
Travel, including air travel, may be required and is an essential function of the job.
Prepare accurate and timely trip reports
Review progress of projects and initiate appropriate actions to achieve target objectives
Organize and make presentations at Investigator Meetings
Participate in the development of protocols and Case Report Forms as assigned
Participate in writing clinical trial reports as assigned
Interact with internal work groups to evaluate needs, resources and timelines
Act as contact for clinical trial supplies and other suppliers (vendors) as assigned
Responsible for all aspects of registry management as prescribed in the project plans
Undertake feasibility work when requested
Conduct, report and follow-up on Monitor Quality Control Visits (MQC) or Quality Control Visits (CQC) when requested
Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management
A minimum of 1 year of Onsite Clinical Monitoring experience is preferred, or an equivalent combination of education and experience to successfully perform the key responsibilities of the job can be substituted.
Ability to monitor study sites independently according to protocol monitoring guidelines, SOP, and local regulatory Guidelines
Have a full understanding of the Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
Good planning, organization and problem-solving abilities
Ability to work with minimal supervision
Good communication and interpersonal skills
Good analytical and negotiation skills
Covance, the drug development business of LabCorp, is recognized as a leader in drug development because of our exceptional people. At Covance, we embrace and celebrate the different strengths, experiences and perspectives of our 20,000+ team members across the globe. Our team is driven by an energizing purpose to improve health and improve lives. Here, you can play a role in bringing new scientific discoveries to life and make a difference in the lives of millions. And, with our comprehensive service portfolio, you’ll have the opportunity to explore diverse projects and unique career paths across the drug development spectrum. Join us and discover your extraordinary potential.
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