Job Title: CRA

Work Location: East Coast preferred, or Central

Summary:

The Clinical Research Associate (CRA) plays a vital role in managing and monitoring clinical sites for diagnostic clinical programs. This position ensures compliance with study protocols, ICH-GCP guidelines, and regulatory requirements, while maintaining high standards of data integrity and site performance. The CRA collaborates with cross-functional teams to support site operations, regulatory documentation, and subject safety throughout the study lifecycle.

Responsibilities:

• Conduct on-site and remote monitoring visits to ensure adherence to study protocols, regulatory guidelines, and monitoring plans.
• Verify source data accuracy and completeness, ensuring consistency with case report forms and study documentation.
• Manage site relationships, drive subject enrollment, resolve queries, and monitor overall site performance.
• Identify, document, and escalate site-level risks, protocol deviations, and data trends, recommending corrective actions as needed.
• Oversee regulatory and study document collection, review, and maintenance to ensure inspection readiness and compliance.
• Support study start-up, initiation, and close-out activities, including site qualification, regulatory document collection, and final monitoring visits.
• Monitor subject safety, review adverse events, and implement corrective and preventive action plans in collaboration with site staff.
• Facilitate site staff training on protocols and systems, mentor junior CRAs, and collaborate with cross-functional teams for study planning and risk management.

Qualifications:

• Bachelor's degree in life sciences, health-related field, or equivalent combination of education and experience.
• 4+ years of clinical monitoring experience, including independent on-site and remote monitoring across multi-site studies.
• Experience monitoring studies for diagnostics, IVD, or regulated medical device products; familiarity with FDA device regulatory pathways is highly valued.
• Strong knowledge of ICH-GCP E6(R2) guidelines, FDA regulations (21 CFR Parts 11, 50, 54, 56, 312, 812), and local clinical research requirements.
• Familiarity with risk-based and central monitoring methodologies.
• Demonstrated ability to independently manage a site portfolio, including enrollment tracking, query management, and protocol deviation documentation.
• Proficiency with EDC systems (iMediNet, Medidata Rave, Oracle InForm, Veeva Vault EDC), CTMS, and eTMF platforms (Veeva Vault TMF, Complion).
• Proficiency in Microsoft Office Suite and Google Workspace.
• Strong written and verbal communication skills, with the ability to author clear monitoring visit reports and professional correspondence.
• Excellent organizational and time management skills, with the ability to manage a high-volume site portfolio and meet deadlines.
• Ability to exercise sound judgment and work independently in ambiguous or high-pressure situations.
• Ability to travel up to 80% of the time, including on short notice; valid driver's license required.
• ACRP or SoCRA certification preferred.
• Experience monitoring infectious disease, microbiology, or molecular diagnostics studies preferred.
• Experience mentoring or training junior CRAs preferred.
• Familiarity with laboratory-developed test and CLIA regulatory frameworks preferred.

Published Category: Clinical Operations & Development