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Clinical Research Associate

Company: Actalent
Location: Columbus
Posted on: September 21, 2022

Job Description:

Description: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 generic-our 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, specifically Pain, Alzheimer's or Neurodegenerative (ie. ALS) Responsibilities of the Role:

  • 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.Additional Skills & Qualifications:
    • Requires a bachelor degree or a two-year nursing degree
    • A minimum of 2 years of field monitoring experience required
    • CNS experience required Acute Pain, Alzheimer's or ALS/Parkinson's preferred
    • Willingness to travel per Region required

      About Actalent:

      Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We're supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
      The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Actalent, Columbus , Clinical Research Associate, Other , Columbus, Georgia

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