Clinical Research Associate
Clinical Research Associate
Intellectt Inc
Columbus, OH
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
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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