Clinical Research Associate II/III (Clinical Research)

TL;DR

Clinical Research Associate II/III (Clinical Research): Conducting site visits and monitoring clinical trials to ensure quality and regulatory compliance with an accent on ICH GCP guidelines and site management. Focus on performing detailed CRF reviews, implementing CAPA plans, and mitigating risks to ensure trial integrity.

Location: Remote (US)

Company

hirify.global is a mid-sized, global Contract Research Organisation (CRO) specializing in Phase I–IV clinical studies to accelerate regulatory pathways.

What you will do

• Perform routine site visits independently, including pre-study, initiation, interim monitoring, and closeout visits.
• Manage assigned sites and maintain regular contact with personnel to ensure compliance and adequate enrollment.
• Conduct independent CRF reviews, query generation, and resolution against data review guidelines.
• Identify and escalate potential risks and implement corrective and preventive (CAPA) plans.
• Prepare documents for EC submissions, notifications, and translate study-related documents when necessary.
• Negotiate study budgets with investigators/institutions and manage site payments.

Requirements

• University degree, preferably in medical or life sciences, nursing, or a relevant healthcare field.
• At least 2 years of independent clinical trial monitoring experience.
• High level of knowledge of ICH GCP Guidelines and regulatory requirements.
• Current, valid driver’s license.
• Ability to read and interpret common scientific and technical journals.
• Excellent verbal and written communication and negotiation skills.

Culture & Benefits

• Comprehensive health insurance, including vision and dental plans.
• Competitive salary and PTO entitlement.
• Comprehensive pension plan.
• Structured career pathway (CRA I → CRA II → CRA III → Senior CRA).
• Training and development programs, well-being initiatives, and employee engagement programs.
• Healthy company culture focusing on life balance.