Senior Clinical Research Associate

TL;DR

Senior Clinical Research Associate: Managing clinical trial monitoring activities and site performance to ensure data integrity and regulatory compliance with an accent on GCP standards and protocol adherence. Focus on conducting site visits, resolving data issues, and overseeing regulatory documentation across the full product lifecycle.

Location: Must be based in the United States. While the role supports remote work, hybrid collaboration is encouraged for those near company offices.

Company

hirify.global provides expert consulting and clinical research solutions to biotech, med device, and pharmaceutical organizations to accelerate scientific breakthroughs.

What you will do

• Conduct site initiation, interim, and close-out monitoring visits both in-person and remotely.
• Review source documents and case report forms to ensure data accuracy, completeness, and integrity.
• Manage investigational supplies, including inventory, dispensing, and reconciliation.
• Oversee regulatory documentation and support clinical sites with regulatory concerns.
• Communicate with investigators, site personnel, and cross-functional teams to address study needs.
• Participate in project team meetings and conference calls to ensure successful trial execution.

Requirements

• Must be based in the United States.
• Bachelor's degree or equivalent combination of education and experience.
• Over 5 years of experience as a Clinical Research Associate.
• Proficiency in EDC, CTMS, IVRS, and eTMF systems.
• Strong knowledge of local laws, regulatory requirements, ICH Guidelines, and GCP.
• Excellent verbal and written communication skills.

Culture & Benefits

• Commitment to diversity, equity, and inclusion.
• Supportive environment that encourages innovative and entrepreneurial spirit.
• Equal Opportunity Employer with a focus on employee empowerment.
• Personalized application review process with guaranteed feedback for all candidates.