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Clinical Research Associate - (Experience req'd) Unblinded - Central Region

Company: Labcorp
Location: Kalamazoo
Posted on: October 12, 2021

Job Description:

Job Overview:

Unblinded CRA

Must be located in the Central Region of the USA 

 

Labcorp Drug Development 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

Keywords: Labcorp, Kalamazoo , Clinical Research Associate - (Experience req'd) Unblinded - Central Region, Other , Kalamazoo, Michigan

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