Clinical Research Coordinator

United Consulting Hub

About the Role

We are seeking a motivated and detail-oriented Clinical Research Coordinator to support the coordination and execution of clinical research studies and trial activities. The role will involve study documentation, site and patient coordination, clinical data management, study tracking, and ensuring compliance with approved protocols, regulations, and quality standards.

Key Responsibilities

• Support the day-to-day coordination and execution of assigned clinical research studies and clinical trials.
• Assist with study start-up activities, site activation, site initiation, and ongoing trial operations.
• Coordinate study activities, timelines, deliverables, and follow-up actions with internal and external stakeholders.
• Maintain essential documents, study files, trackers, correspondence, and clinical records in accordance with study requirements.
• Support patient recruitment, pre-screening, screening, scheduling, follow-up, and study visit coordination.
• Enter, review, reconcile, and maintain accurate clinical data in EDC, CTMS, and other applicable clinical systems.
• Assist with monitoring visits, quality reviews, audits, regulatory inspections, and study reporting activities.
• Identify, document, track, and escalate protocol deviations, data discrepancies, compliance issues, and study risks.
• Ensure clinical study activities comply with ICH-GCP, FDA requirements, SOPs, informed consent requirements, and approved study protocols.
• Collaborate with Clinical Operations, Data Management, Safety, Quality, Regulatory, and other cross-functional teams.
• Participate in study meetings, document action items, and follow up on assigned deliverables and timelines.
• Escalate study-related risks, data quality concerns, compliance issues, and operational challenges to appropriate team members.
• Perform additional clinical research, documentation, coordination, and administrative activities as assigned.

Requirements & Tech Stack

• Basic understanding of clinical research processes, study protocols, informed consent, and essential clinical trial documentation.
• Familiarity with clinical systems such as EDC, CTMS, eTMF, or similar platforms.
• Proficiency in Microsoft Office, including Word, Excel, PowerPoint, and Outlook.
• Strong attention to detail with the ability to maintain accurate, complete, and timely documentation.
• Good written and verbal communication skills with the ability to collaborate effectively with cross-functional teams.
• Strong organizational and time-management skills with the ability to manage multiple priorities and deadlines.
• Basic knowledge of ICH-GCP, FDA requirements, and clinical trial compliance principles is preferred.
• Ability to work independently and effectively in a remote, collaborative, and deadline-driven environment.