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Clinical Research Associate - CNS (Anywhere in Mid-Atlantic

Company: Worldwide Clinical Trials
Location: Raleigh
Posted on: February 15, 2020

Job Description:

Worldwide is global leader in CNS clinical research with unrivaled experience. From psychiatry and neurology to analgesia and addiction drug development, our expertise spans translational medicine through registration studies and peri-approval activities including registries and other observational research that have a pharmacoeconomic intent. Whether a compound is an original small molecule, injectable large molecule or a bioequivalent genericour neuroscience experts are true specialists.

Our Clinical Research Associates (CRA) are home-based and have 8 on-site days monthly. They are responsible for site qualification, initiation, interim monitoring, site management and study close-out visits for studies in accordance with Good Clinical Practices (GCPs) and applicable local and international regulations and Standard Operating Procedures (SOPs). Ensure quality of data submitted from study sites and assure timely submission of data, including appropriate reporting and follow-up for all safety events by site personnel. This particular role will focus on CNS.

RESPONSIBILITIES:


  • Write site visit trip reports
  • Compile and ensure completeness of regulatory documents and ethical submission documentation as appropriate and required (e.g. IRB / IEC study approval, informed consent, etc.)
  • Coordinate study material (e.g. CRFs, manuals) shipment and receipt by study site
  • Document site visit findings via written reports
  • Review study subject safety information and informed consent
  • Conduct source document verification for compliance, patient safety, and veracity of data
  • Review CRFs using paper or electronic data capture systems and assist sites with data query resolution
  • Maintain regular communication with sites

    Perform other duties as assigned. The duties and responsibilities listed above are representative of the nature and level of work assigned and are not necessarily all-inclusive.

    REQUIREMENTS:

    • Requires a bachelor degree or a two-year nursing degree
    • A minimum of 2 years of field monitoring experience required
    • CNS experience required, Neurodegenerative experience a plus
    • Willingness to travel required
    • Valid current passport required
    • Driving license required
    • Fluent in the local languages of the countries under responsibilities and proficient in both spoken and written English

      Worldwide Clinical Trials is an Equal Opportunity Employer

Keywords: Worldwide Clinical Trials, Raleigh , Clinical Research Associate - CNS (Anywhere in Mid-Atlantic, Healthcare , Raleigh, North Carolina

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