Medical Reviewer/Safety Reviewer II
The Fountain Group is a national staffing firm and we are currently seeking a Clinical Safety Analyst / Medical Reviewer (RN Preferred) for a prominent client of ours. This position is 100% REMOTE . Details for the position are as follows: Clinical Safety Analyst / Medical Reviewer (RN Preferred) 100% Remote (U.S. Based) $35-$37/hour 2-Year Contract (Potential to Convert) Full-Time | Standard Business Hours (aligned to Central Time)
Overview
We are seeking a Clinical Safety Analyst / Medical Reviewer to support ongoing clinical trials within a Clinical Trial Patient Safety (CTPS) team. This role is ideal for Registered Nurses or clinically trained professionals looking to transition from bedside care into the pharmaceutical industry. In this position, you will apply your clinical knowledge to review adverse event (AE) data, ensure data accuracy and completeness, and support patient safety monitoring across clinical studies.
Key Responsibilities
- Review clinical trial safety data, including:
- Adverse events (AEs)
- Laboratory results
- Vital signs
- Medications and medical history
- Perform medical review of Case Report Forms (CRFs) for accuracy and completeness
- Identify inconsistencies or missing information and issue queries to investigative sites
- Document follow-ups, write addenda, and support case resolution and closure
- Ensure safety data aligns with study protocols and regulatory requirements (ICH, FDA, EMA)
- Collaborate with Clinical Safety Analysts (CSAs) on case reviews and escalations
- Support safety surveillance activities and potential trend identification
- Maintain organized documentation for audits and regulatory review
Qualifications
- Bachelor’s degree required (RN/BSN strongly preferred)
- Minimum 2 years of bedside patient care experience (hospital/inpatient setting preferred)
- Clinical background in nursing, pharmacy, or related health science field
- Strong clinical judgment and ability to assess patient safety data
- Excellent attention to detail and documentation skills
- Ability to work independently in a high-volume, data-driven environment
- Strong written and verbal communication skills
Preferred Experience
- Exposure to adverse event reporting, pharmacovigilance, or clinical trial safety
- Experience reviewing medical records, charts, or clinical data
- Familiarity with systems such as:
- Medidata Rave
- Veeva
- Argus or similar safety databases
Additional Details
- Fully remote role (must be based in the U.S.)
- Must be a U.S. Citizen or Green Card holder (no sponsorship available)
- Structured onboarding and training program provided
- Opportunity to gain experience in drug safety and clinical research
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