Clinical Research Associate - (Experience req'd) Unblinded - COVID Vaccine- Southeast USA

Job Overview:

Unblinded CRA

Must be located in Central USA

Covance is seeking an Unblinded CRA to primarily focus 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

#LI-Remote Education/Qualifications:University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure). An equivalent amount of experience can be substituted as appropriate. Experience:A minimum of 1 year of Onsite Clinical Monitoring experience is preferred Early Stage experience is preferred. Thorough knowledge of ICH Guidelines and understanding of local regulatory requirements Thorough knowledge of monitoring procedures  Basic understanding of the drug accountability process Valid Driver's License 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