Clinical Research Coordinator

Company Description i-verve Inc. modernizes regulated businesses’ legacy platforms and integrates AI into existing technologies such as .NET Framework, Java EE, AngularJS, HL7 v2, and SSIS-era systems. The company delivers measurable results, including transforming a monolithic payment system into microservices with significantly improved fraud detection and cost savings. i-verve serves clients in FinTech and Banking, Insurance, HealthTech, and Logistics who face evolving compliance and interoperability requirements. Headquartered in New Jersey with a delivery center in Ahmedabad, the organization has 80+ engineers and holds ISO 27001, ISO 9001, and SOC 2 Type II certifications. i-verve is a Microsoft AI Cloud Partner and is SAM.GOV registered, providing secure, compliant, and scalable solutions.
Role Description This is a remote, contract role for a Clinical Research Coordinator. The individual in this role will coordinate and manage clinical research studies from start-up through close-out, ensuring adherence to study protocols and regulatory requirements. Day-to-day responsibilities include overseeing participant recruitment and screening, managing informed consent processes, scheduling study visits, and maintaining accurate and timely source documentation and case report forms. The coordinator will communicate regularly with principal investigators, sponsors, monitors, and internal stakeholders, assist with IRB submissions, and support compliance with Good Clinical Practice (GCP) and institutional policies. The role also involves tracking study progress, reporting adverse events, and contributing to data quality and audit readiness across assigned clinical trials.
Qualifications
Demonstrated clinical research experience, including coordination of Clinical Trials and familiarity with end-to-end study workflows.
Strong understanding of Protocol requirements and ability to ensure protocol adherence across all study activities.
Knowledge and practical experience with Informed Consent processes, including participant education and documentation standards.
Proficiency in Research practices, including data collection, source documentation, and basic data analysis for accuracy and completeness.
Bachelor’s degree in a health-related or scientific field (e.g., Nursing, Public Health, Biology, Pharmacology) or equivalent experience.
Knowledge of GCP, ICH guidelines, and applicable regulatory frameworks (e.g., FDA, IRB/IEC requirements).
Strong organizational, time-management, and multitasking skills, with the ability to coordinate multiple studies or sites remotely.
Effective written and verbal communication skills, with the ability to interact professionally with participants, investigators, and sponsors.
Comfort with electronic data capture systems, clinical trial management systems, and standard productivity tools.
Prior experience in HealthTech, regulated environments, or technology-enabled clinical research settings is beneficial.

Work arrangement
No