Clinical Research Associate (Pharmaceuticals)

TL;DR

Clinical Research Associate (Pharmaceuticals): Monitoring the execution of clinical studies to ensure compliance with GCP and ICH guidelines with an accent on study site monitoring and regulatory documentation. Focus on ensuring quality and timeliness of clinical trials through rigorous site audits and cross-functional collaboration.

Location: United States

Company

hirify.global is a company specializing in pharmaceutical development and clinical research.

What you will do

• Monitor study sites to ensure strict compliance with study documentation and established procedures.
• Collect, review, and organize regulatory documents and study-related files from clinical sites.
• Collaborate with the clinical research team to resolve issues at study sites and implement solutions.
• Track study progress to ensure quality and timely completion of all milestones.
• Oversee the storage, distribution, and return of study medications and devices for compliance.
• Prepare and submit required reports and documentation to regulatory authorities.

Requirements

• Bachelor's degree in a related field or equivalent direct pharmaceutical industry experience.
• At least 5 years of professional experience in the pharmaceutical industry.
• Strong familiarity with GCP standards, ICH guidelines, and federal regulations.
• Excellent oral and written communication skills.
• Proficiency in Microsoft Office Suite, including Word, Excel, and PowerPoint.
• Ability to work effectively in fast-paced, cross-functional team environments.