Clinical Research Coordinator

About the Role

We are looking for a motivated and organized Clinical Research Coordinator to assist with clinical trial management, study coordination, and research documentation within pharmaceutical and life sciences environments. This role involves supporting study start-up, coordinating trial activities, maintaining clinical records, and ensuring compliance with established protocols, regulatory guidelines, and quality standards.

Key Responsibilities

• Assist in coordinating and managing assigned clinical research studies and clinical trial activities.
• Support study start-up, regulatory document collection, site activation, and site initiation activities.
• Track study timelines, milestones, deliverables, and follow-up actions to ensure timely completion.
• Prepare, organize, and maintain essential trial documents, study files, correspondence, trackers, and clinical records.
• Assist with participant recruitment, eligibility screening, visit scheduling, follow-ups, and study-related communications.
• Enter, verify, and maintain clinical trial data using EDC, CTMS, and other relevant clinical research systems.
• Support monitoring activities, quality checks, audit preparation, regulatory inspections, and clinical study reporting.
• Assist in identifying, documenting, and tracking protocol deviations, data inconsistencies, compliance concerns, and operational risks.
• Ensure study activities follow ICH-GCP guidelines, applicable FDA regulations, SOPs, informed consent procedures, and approved study protocols.
• Coordinate with Clinical Operations, Data Management, Pharmacovigilance, Quality Assurance, and Regulatory Affairs teams.
• Participate in study meetings, prepare meeting notes, track action items, and follow up on outstanding tasks.
• Communicate study progress, documentation gaps, data quality issues, and potential compliance risks to the appropriate team members.
• Perform additional research coordination, document management, and administrative responsibilities as required.

Requirements & Tech Stack

• Basic understanding of clinical trial operations, study protocols, informed consent procedures, and essential clinical trial documentation.
• Familiarity with clinical research platforms such as EDC, CTMS, eTMF, or similar electronic systems.
• Proficiency in Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook.
• Strong attention to detail and the ability to maintain accurate, complete, and organized clinical documentation.
• Effective written and verbal communication skills with the ability to coordinate across multiple teams.
• Good organizational, analytical, and time-management skills to manage competing priorities and deadlines.
• Ability to work independently and collaboratively in a remote, team-oriented, and deadline-driven environment.

Qualifications

• Basic knowledge of ICH-GCP, FDA regulations, and clinical research compliance requirements is preferred.