Clinical Research Coordinator

United Consulting Hub seeks a Clinical Research Coordinator to support the coordination and execution of clinical research studies and trial activities. The role focuses on study documentation, site and patient coordination, clinical data management, study tracking, and compliance with approved protocols, regulations, and quality standards.

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

Preferred

Basic knowledge of ICH-GCP, FDA requirements, and clinical trial compliance principles is preferred

ICH-GCP Knowledge

FDA Requirements Knowledge

Clinical Trial Compliance

Benefits

Remote work

Company

Pharmaceutical, biotech, and medical device validation consulting

Metuchen, New Jersey, USA

https://unitedconsultinghub.com/

Founded in 2021

51-200 employees

Qualifications

Experience: 0–2 Years

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

Ability to work independently and effectively in a remote, collaborative, and deadline-driven environment

Basic knowledge of ICH-GCP, FDA requirements, and clinical trial compliance principles is preferred

Required skills

Clinical Research, Clinical Trial Documentation, Informed Consent, Electronic Data Capture (EDC), Clinical Trial Management Systems (CTMS), Electronic Trial Master File (eTMF), Microsoft Office, ICH-GCP, FDA Requirements

Preferred skills

Organization and Time Management

Experience

Entry level