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Clinical Research Associate II (Phase 1)

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

Job Description:

Job Overview:

Why join Labcorp Drug Development? We are a top leader in the industry with a collaborative and supportive environment for growth opportunities. This position is home-based, traveling 8-10 days a month.


  • 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
  • General On-Site Monitoring Responsibilities
  • Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study

Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements

  • Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document Monitor data for missing or implausible data
  • Ensure the resources of the Sponsor and Labcorp are spent wisely by per forming the required monitoring tasks in an efficient manner, according to SOPs and established guidelines, including managing travel expenses in an economical fashion according to Labcorp travel policy
  • Travel, including air travel, may be required and is an essential function of the job
  • Prepare accurate and timely trip reports
  • Responsible for all aspects of registry management as prescribed in the project plans
  • Undertake feasibility work when requested
  • Recruitment of potential investigators, preparation of EC submission notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor
  • Negotiate study budgets with potential investigators and assist the legal department with statements of agreements as assigned
  • Complete Serious Adverse Event (SAE) reporting, process production of repo11s, narratives and follow up of  SAEs
  • Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management
  • Assist with training of new employees, g. co-monitoring
  • Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable) and may act as a local client contact as assigned
  • Perform other duties as assigned by management


External candidates:

  • University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g. nursing licensure


  • Thorough knowledge of Covance SOPs for site monitoring.



Minimum Required:

External Candidates

  • Minimum of 2 years of Clinical Monitoring
  • Ability to monitor study sites independently according to protocol monitoring guidelines, SOPs, GCP and ICH 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
  • Ability to work with minimal
  • Good communication and interpersonal
  • Good analytical and negotiation
  • Fluent in local office language and in English, both written and
  • Works efficiently and effectively in a matrix environment






Keywords: Labcorp, Raleigh , Clinical Research Associate II (Phase 1), Other , Raleigh, North Carolina

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