Clinical Research Coordinator

Job Overview

The Clinical Research Coordinator (CRC) plays a vital role in managing and coordinating clinical trials, ensuring all activities align with study protocols, Good Clinical Practice (GCP) standards, institutional policies, and regulatory mandates. This position focuses on participant recruitment, managing study documentation, data collection, and facilitating the efficient conduct of clinical research while upholding participant safety and data accuracy.

Primary Responsibilities

• Manage daily operations of assigned clinical studies.
• Review and ensure adherence to study protocols throughout trial execution.
• Recruit, screen, and enroll study participants based on established inclusion and exclusion criteria.
• Obtain and record informed consent from participants before initiating study procedures.
• Arrange participant appointments and coordinate all study-related assessments and follow-ups.
• Accurately collect and maintain study data using Case Report Forms (CRFs) and Electronic Data Capture (EDC) systems.
• Maintain essential regulatory documentation, including investigator site files and study records.
• Monitor and report adverse events and serious adverse events promptly as per regulations.
• Collaborate with Principal Investigators, sponsors, CROs, laboratory staff, and other relevant personnel.
• Assist in preparation and support of sponsor monitoring visits, audits, and regulatory inspections.
• Track study progress against timelines, recruitment goals, and protocol milestones.
• Support study initiation, protocol amendments, close-out procedures, and documentation archiving.
• Ensure confidentiality of participant and research data at all times.

Qualifications and Skills

• Bachelor's degree in Life Sciences, Pharmacy, Nursing, Biotechnology, Medicine, or related healthcare disciplines.
• Experience in clinical research or trial coordination is preferred.
• Certification in Good Clinical Practice (GCP) is advantageous.
• Comprehensive understanding of clinical trial processes and ethical research conduct.
• Knowledgeable about ICH-GCP guidelines and applicable regulatory frameworks.
• Outstanding organizational and time management capabilities.
• Excellent verbal and written communication skills.
• High attention to detail and accuracy in documentation and data management.
• Proficient in Microsoft Office suite and Electronic Data Capture systems.
• Ability to work autonomously and collaboratively within interdisciplinary teams.
• Strong problem-solving and interpersonal skills.

Work Environment

This role is commonly based within hospitals, research institutions, academic medical centers, or clinical research organizations. Flexibility in working hours may be required to accommodate participant schedules and sponsor visits.