Medical Reviewer/Safety Reviewer II - Clinical Trial Safety Surveillance & Medical Review

Medical Reviewer/Safety Reviewer II - Clinical Trial Safety Surveillance & Medical Review
Location: Remote - Candidates have to be located in the US and able to work without visa sponsorship
Length of Assignment: 2 years
Pay Rate: $31-37/hr (depending on candidate location and medical benefits preference)


Job Description:
The Medical Reviewer/Safety Reviewer II provides timely clinical and medical review of reported clinical-trial data and participates in safety-surveillance activities for assigned studies. The position evaluates safety data for quality, completeness, potential study-level trends, and adherence to applicable regulatory guidance, protocols, departmental processes, and policies.

Key Responsibilities:

• Assess reported clinical-trial data, including laboratory results, vital signs, cardiac data, medications, medical history, and other safety-related information; communicate relevant findings to the Study Lead.
• Review safety-related clinical-trial data for content, quality, potential study-level trends, and adherence to regulatory guidance and study protocols, using strong critical-thinking skills.
• Conduct in-house medical review of Case Report Forms (CRFs), including query resolution, addenda writing, and quality assurance of data listings.
• Monitor and support resolution of safety-related queries issued to investigators.
• Maintain current knowledge of ICH, FDA, and EMA regulatory guidance affecting clinical-trial safety surveillance.
• Investigate and report medical product experiences and adverse events, including in-depth review of medical adverse events and collaboration with Medical Affairs, Clinical, and Regulatory Affairs on documentation prepared for the FDA.
• Provide medical communications support, including standard and customized responses to requests from medical professionals and the public that require complex medical or scientific information, including appropriate dissemination of off-label information.
• Provide training internally and at investigator meetings regarding safety issues, serious adverse events, and CRF completion, as assigned.
• Write study summaries and review protocols, study summaries, investigator brochures, and IND annual updates for safety-data verification.
• May manage activities of regional contract CRAs and organize files and budgets associated with multiple clinical studies.
• Perform responsibilities with minimal supervision while adhering to applicable regulatory guidance, protocols, and departmental processes and policies.

Qualifications:

• Bachelor's degree with a related health-science background; Registered Nurse or clinical pharmacy experience is strongly preferred.
• Minimum of 2 years of clinical-practice experience is required; at least 1 year of drug-safety experience is preferred.
• Strong critical-thinking skills and the ability to apply clinical knowledge to adverse-event data collection and assessment.
• Ability to present accurate and medically sound safety data both orally and in writing.
• Effective communication skills when delivering study-related information.
• Proficiency with Windows, Microsoft Word, and Microsoft Excel.

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