Medical Reviewer/Safety Reviewer II

job summary:
Advance your career in clinical research with this fully remote Medical Reviewer/Safety Reviewer II role, where you will directly impact patient safety and study integrity. You will be responsible for assessing complex clinical trial data, ensuring regulatory adherence, and serving as a critical touchpoint between investigators and medical affairs teams.

Our client is dedicated to pushing the boundaries of clinical innovation, and you can get a better sense of their mission and the team environment by visiting their careers page to see how they are helping to advance global healthcare standards.

location: Telecommute
job type: Contract
salary: $32.00 - 36.65 per hour
work hours: 9 to 5
education: Bachelors

responsibilities:
• Conduct thorough in-house medical reviews of Case Report Forms (CRFs), including query resolution, addenda writing, and quality assurance of data listings.
• Perform ongoing safety surveillance by evaluating clinical trial data, including labs, vital signs, cardiac data, and medical history.
• Investigate and document Adverse Event (AE) reports, collaborating closely with Medical Affairs and Regulatory teams to prepare comprehensive documentation for the FDA.
• Identify potential study-level safety trends using critical thinking skills, ensuring strict adherence to protocols and departmental processes.
• Manage communications regarding safety-related queries to Investigators and provide medical information to the community regarding complex clinical inquiries.
• Provide internal training and support during investigator meetings on safety issues, CRF completion, and protocol updates.

qualifications:Required Skills
• Bachelor's degree with a related health science background.
• Minimum of 2 years of direct clinical practice experience.
• Strong critical thinking skills with the ability to apply clinical knowledge to adverse event data collection and assessment.
• Proficiency with computer systems, specifically Windows, Microsoft Word, and Excel.
• Ability to present accurate, medically sound safety data clearly, both orally and in writing.
• Effective communication skills for delivering study-related information.
Preferred Skills
• Active licensure as a Registered Nurse (RN) or clinical pharmacist.
• At least 1 year of professional drug safety experience.
#LI-ST1

skills: MS-EXCEL, Quality Assurance (QA), International Council for Harmonization (ICH), FDA Submissions

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 and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact [email protected].

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, 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.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.