Clinical Research Associate II

Company: Labcorp
Location: Charleston
Posted on: March 17, 2023

Job Description:

Clinical Research Associate SoutheastOncology Experience Required As a leading contract research organization (CRO), Labcorp Drug Development provides comprehensive drug development solutions for a range of industries. Our services cover the preclinical, clinical and post-market phases of drug development, the product life cycles for medical device and diagnostics and development services paired with regulatory support for the chemical testing and crop protection industries.
Labcorp Drug Development is a global leader in nonclinical safety assessment, clinical trial testing and clinical trial management services. Our unique perspectives are based on decades of scientific, medical and regulatory expertise.
Did you know?
In July 2022, Labcorp announced its intention to spin off its clinical development business as a separate public company, subject to the satisfaction of certain customary conditions. Fortrea will become the new brand identity for our Clinical Development business in connection with the spin-off, which is expected in mid-2023.
We believe that the exceptional is possible when you have the right partner, so we are looking for the right people to help build a transformative force in Clinical Development.
Why settle for one thing when you can have everything? Labcorp Drug Development gives you the best two for one opportunity for career growth. Who doesn't want twice the perks - working at one of the largest FSP CROs-and partnering with one sponsor with a dedicated therapeutic focus. Our Energizing Purpose, Exceptional People and Extraordinary Potential combined with collaborative and proactive teams offer a great place for you to continue honing your therapeutic skills and growing and excelling in new exciting research. Our reach is global - extending to 60+ countries making us one of the largest FSP CROs. So, no matter where you are located on the globe, we have an FSP opportunity for you. We are seeking a CRA to be responsible for all aspects of study site monitoring and management 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. Additional responsibilities include:

• Organize and make presentations at Investigator Meetings
• Participate in the development of protocols and Case Report Forms as assigned
• Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned
• Negotiate study budgets with potential investigators and assist the Covance legal department with statements of agreements as assigned
• Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management Requirements:
  • 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.
  • COVID-19 vaccination required
  • Minimum of at least 1 year of Onsite Clinical Monitoring experience along with at least 1 year total in clinical research experience is required.
    • 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 Great Benefits at Labcorp: Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including:
      • Medical
      • Dental
        • Vision
        • Life, STD/LTD
        • 401(K)
        • Employee Stock Purchase Plan (ESPP)
        • Paid time off (PTO) or Flexible time off (FTO)
          • Company bonus where applicable Labcorp is proud to be an Equal Opportunity Employer:
            As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
            For more information about how we collect and store your personal data, please see our Privacy Statement .

Keywords: Labcorp, Charleston , Clinical Research Associate II, Healthcare , Charleston, South Carolina