Intellectt Inc

Clinical Research Associate

Intellectt Inc Columbus, OH
Intellectt Inc

Clinical Research Associate

Intellectt Inc Columbus, OH
4 months ago 66 applicants

See who Intellectt Inc has hired for this role

Role: Clinical Research Associate

Location: Columbus, OH - 43219

Duration: 12+ Months

Shift Timings: 8 am to 5 pm

Job Description

  • Responsibilities include medical review, which involves in-house review of Case Report Forms (CRFs) including query resolution and addenda writing, QA of data listings.
  • May manage the activities of regional contract CRAs, and organize the files and budgets associated with several clinical studies.
  • Provides medical support which may include: Adverse Event Reporting - the investigation and reporting of medical product experiences.
  • In depth investigation of medical adverse events and works with Medical Affairs, Clinical, and Regulatory Affairs in the preparation of documentation on adverse events for the FDA; or Medical Communication which includes writing standard and custom responses to communication requests.
  • In-depth assistance to the medical and lay community by responding to inquiries with medical/scientific information that is more complex and requires more data than is supplied in the package insert or the standard letter database.
  • Off-label information would be disseminated at this level.
  • May provide training internally and at investigator meetings on safety issues.
  • Responsible for serious adverse events and CRF completion, writing study summaries, and reviewing protocols, study summary investigator brochures and IND annual updates for safety data verification.
  • 0 to 3 Years Experience Level.

  • Seniority level

    Associate

  • Employment type

    Contract

  • Job function

    Research, Analyst, and Information Technology

  • Industries

    Staffing and Recruiting

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