Clinical Research Coordinator

United Consulting Hub is seeking a Clinical Research Coordinator to support clinical trial management, study coordination, and research documentation. The role assists with study start-up, trial activities, clinical records, and compliance with protocols and regulatory guidelines.

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

Preferred

• Basic knowledge of ICH-GCP, FDA regulations, and clinical research compliance requirements
• ICH-GCP
• FDA Regulations
• Clinical Research Compliance

Company

• Pharmaceutical, biotech, and medical device validation consulting
• Metuchen, New Jersey, USA
• https://unitedconsultinghub.com/
• Founded in 2021
• 51-200 employees

Qualifications

• 0–2 Years
• 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
• Basic knowledge of ICH-GCP, FDA regulations, and clinical research compliance requirements

Required skills

• CTMS, Clinical Study Protocols, Clinical Trial Operations, EDC, FDA Regulations, ICH-GCP, Informed Consent Procedures, Microsoft Office, eTMF

Preferred skills

• AI Tools, Analyze How Well You Fit, Babjee M, Build Cover Letter, Company data provided by, Customize Your Resume, Founder, Growth Stage, Leadership Team, Make your application stand out, Maximize your interview chances, Metuchen, New Jersey, USA, Understand your strength & weakness, https://unitedconsultinghub.com

Experience

• Entry level