Senior Central Monitor (Remote)

Location: United States; remote work is supported, with hybrid work encouraged for new hires living within a reasonably short commute of a hirify.global office.

Company

hirify.global provides consulting and operational 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

• Perform remote site monitoring and management activities in line with FDA and local regulations, ICH GCP, SOPs, and study plans.
• Support monitoring teams in implementing study strategies, processes, and quality standards.
• Collect and report data on recruitment, enrollment, drug supply, site payments, and other clinical trial metrics.
• Support data risk assessments and centralized monitoring activities.
• Coordinate with clinical site institutions and assist with document collection, visit preparation, and study data review.

Requirements

• At least 3 years of experience in study coordination, in-house monitoring, biotechnology, pharmaceuticals, or another regulated environment.
• Experience using electronic document management, electronic data capture, and clinical trial management systems.
• Understanding of quality assurance concepts and practices.
• Strong communication, interpersonal, organizational, prioritization, and attention-to-detail skills.
• A bachelor’s degree is preferred; comparable training and experience may be considered.

Nice to have

• Working knowledge of the Cluepoints RBQM System.
• Long-haul COVID or pulmonary experience.

Culture & Benefits

• Remote working support with the option of hybrid collaboration for employees located near an office.
• Inclusive workplace focused on diversity, equity, and inclusion.
• Environment encouraging innovation, collaboration, and entrepreneurial initiative.
• Equal opportunity employment and a commitment to reviewing applications personally.

Hiring process

• Applications are personally reviewed by a member of the recruitment team.
• Applicants receive an outcome notification after the application review.