Senior Clinical Research Associate (Medical)

TL;DR

Senior Clinical Research Associate (Medical): Performing clinical monitoring for assigned protocols and investigational sites with an accent on GCP compliance, regulatory requirements, and site management. Focus on conducting monitoring visits, ensuring data integrity, and managing the site lifecycle from initiation to close-out.

Location: London, UK & Ireland (Hybrid/Remote options available)

Company

hirify.global provides end-to-end consulting solutions in regulatory sciences and clinical research to accelerate drug and device programs for biotech and pharmaceutical organizations.

What you will do

• Conduct all types of monitoring visits (initiation, interim, close-out) both in-person and remotely.
• Ensure studies are conducted and documented according to protocols, SOPs, GCP, and regulatory requirements.
• Manage site personnel training and oversee proper source documentation and case report completion.
• Review source documents and case report forms for accuracy, completeness, and data integrity.
• Oversee regulatory documentation and manage investigational supplies dispensing and inventory.
• Communicate with investigators, site personnel, and cross-functional teams to address study needs.

Requirements

• More than 5 years of experience as a Clinical Research Associate.
• Bachelor's degree or equivalent combination of education and experience.
• Proficiency in EDC, CTMS, IVRS, and eTMF.
• In-depth knowledge of local law, regulatory requirements, ICH Guidelines, and GCP.
• Excellent verbal and written communication and interpersonal skills.

Culture & Benefits

• Support for remote working with a hybrid option for those based near company offices.
• Strong commitment to diversity, equity, and inclusion.
• Culture that encourages innovative, collaborative, and entrepreneurial spirits.
• Transparent recruitment process with personal review of all applications and no AI screening tools.