Medical Reviewer

Overview

Provides timely assessment of reported clinical trial data and participates in applicable safety surveillance activities for assigned studies, including review of labs, vital signs, cardiac data, medications, and medical history. Communicates findings to the Study Lead.

Reviews safety-related data from clinical trials for content, quality, potential study-level trend identification, and adherence to regulatory guidance and protocols using critical thinking skills. Monitors safety-related queries to investigators. Adheres to regulatory guidance, protocols, departmental processes and policies under minimum supervision. Maintains knowledge of ICH, FDA, and EMA regulatory guidance affecting safety surveillance.

• Medical review, including in-house review of Case Report Forms (CRFs), query resolution, addenda writing, and QA of data listings.
• May manage activities of regional contract CRAs and organize files and budgets associated with several clinical studies.
• Provide medical support, including Adverse Event Reporting (investigation and reporting of medical product experiences) and collaboration with Medical Affairs, Clinical, and Regulatory Affairs in preparing documentation on adverse events for the FDA.
• Provide Medical Communication, including writing responses to inquiries with medical/scientific information more complex than standard package inserts or letter databases.
• Off-label information may be disseminated at this level.
• Provide training internally and at investigator meetings on safety issues; responsible for serious adverse events and CRF completion; write study summaries; review protocols, study summaries, investigator brochures, and IND annual updates for safety data verification.

• Bachelors degree with related health science background; RN or clinical pharmacy experience strongly preferred.
• Minimum of 2 years of clinical practice experience; 1 year of drug safety experience preferred.
• Strong critical thinking skills with ability to apply clinical knowledge to adverse event data collection and data assessment.
• Ability to present accurate and medically sound safety data, both orally and in writing.
• Effective communication skills in delivering study-related information.
• Proficiency in Windows-based computers (Word, Excel).

Skills:

Adverse Event (AE) Reporting, IND, FDA, ICH.

Equal Opportunity

Employer:

Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities. If you require a reasonable accommodation to make your application or interview experience a great one, please contact

Pay offered to a successful candidate will be based on several factors including education, experience, location, duties, certifications, etc. Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).

This posting is open for thirty (30) days.