Lead Clinical Research Coordinator

TL;DR

Lead Clinical Research Coordinator (Medical): Managing and coordinating daily clinical trial activities, ensuring protocol compliance, data integrity, and participant safety. Focus on study operations, workflow optimization, and adverse event management.

Location: Must reside in NYC

Company

hirify.global provides advice and expertise that empowers biotech, med device, and pharmaceutical organizations to confidently advance scientific breakthroughs and introduce new therapies.

What you will do

• Independently conduct and manage assigned clinical trials in accordance with study protocols, GCP/ICH guidelines, FDA regulations, and company SOPs, from site initiation through study close-out.
• Implement and coordinate all aspects of assigned trials including start-up activities, vendor management, subject recruitment and retention, source document development, visit scheduling, regulatory document collection, protocol training, EDC data entry, query resolution, amendment implementation, and close-out reporting.
• Manage, monitor, and report adverse events, serious adverse events (SAEs), and protocol deviations to Sponsors and IRBs with accurate and timely documentation.
• Prepare for and lead monitoring visits, audits, and inspections; resolve data queries and protocol issues identified by monitors in a timely and professional manner.
• Perform procedures and assessments per protocol, including phlebotomy, ECGs, drug preparation and administration, and lab specimen processing.

Requirements

• Minimum 4–5 years of experience managing multiple Phase II-III industry-sponsored clinical trials as the lead coordinator.
• Bachelor's degree required; clinical credential (RN, LPN, MA) or Master's degree a plus.
• GCP Certification required; CCRC or CCRP certification strongly preferred.
• Demonstrated mastery of ICH/GCP guidelines, FDA regulations, and CFR requirements governing human subject research.
• Experience with EDC systems, eSource documentation (Preferably CRIO).
• Bilingual - English & Spanish Required

Culture & Benefits

• Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits.
• With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
• hirify.global supports remote working and encourages new hires based within a reasonably short commute of one of our offices to work on a hybrid basis.