Senior Clinical Research Associate (Alzheimer's Disease)

Location: United States. Remote work is supported; employees within a reasonably short commute of a hirify.global office may work on a hybrid basis as agreed with their manager.

Company

hirify.global provides consulting solutions across regulatory sciences, clinical research, quality and compliance, pharmacovigilance, medical information, and R&D technology for biotech, medical device, and pharmaceutical organizations.

What you will do

• Conduct and oversee in-person and remote monitoring, co-monitoring, site initiation, interim, and close-out visits.
• Prepare monitoring reports and complete monitoring activities according to SOPs and applicable regulatory requirements.
• Support study start-up activities, including site identification, feasibility, essential documents, and Ethics Committee submissions where applicable.
• Review source documents and case report forms, resolve data issues, and monitor protocol deviations, serious adverse events, laboratory abnormalities, enrollment, and site termination updates.
• Manage investigational supplies, including shipment, dispensing, inventory, reconciliation, and documentation.
• Communicate with clinical sites, investigators, sponsors, project teams, and external partners while supporting protocol training and site management.

Requirements

• Bachelor's degree or an equivalent combination of education and experience.
• More than 5 years of experience as a Clinical Research Associate.
• More than 3 years of experience monitoring Alzheimer's disease studies.
• Experience with EDC, CTMS, IVRS, and eTMF systems.
• Knowledge of applicable laws, regulatory requirements, ICH Guidelines, and GCPs governing clinical trials.
• Strong communication, presentation, organizational, planning, prioritization, and problem-solving skills with the ability to work with minimal supervision.

Culture & Benefits

• Remote working is supported, with hybrid work encouraged for new hires located near a hirify.global office.
• Inclusive workplace focused on diversity, equity, and inclusion.
• Environment that encourages innovation, collaboration, entrepreneurship, and authentic participation.
• Applications are reviewed personally by the recruitment team without AI screening tools.
• Equal opportunity employer committed to providing a safe and empowering workplace.