Job Description

Clinical Research Coordinator

Job Summary

The Clinical Research Coordinator (CRC) plays a key role in managing and processing clinical research data and documentation, including regulatory and patient records. This role involves conducting clinical procedures, coordinating daily workloads, and ensuring compliance with study protocols, standard operating procedures (SOPs), and Good Clinical Practices (GCPs).

Responsibilities

• Support investigators in executing research studies, ensuring adherence to protocols and regulatory requirements.
• Collect, record, and maintain study data with a focus on accuracy, completeness, and quality control.
• Prepare and submit regulatory and ethics documentation in compliance with FDA and other governing bodies.
• Recruit and screen potential study participants while maintaining detailed screening logs.
• Guide research participants through the consent process, explaining study objectives, procedures, and expectations.
• Maintain and update source documentation per protocol requirements.
• Schedule and conduct study visits, executing necessary procedures.
• Manage lab testing logistics, including specimen preparation, collection, and shipment.
• Monitor participant safety and report adverse events to the Principal Investigator or appropriate medical personnel.
• Address participant inquiries and resolve study-related concerns.
• Participate in daily team meetings to review study tasks and ensure proper execution.
• Assist with data validation, quality control, and resolving queries.
• Perform clinical research procedures such as ECGs, sample collection, spirometry, vital signs monitoring, dose verification, cannulation, and cardiac telemetry as required.
• Ensure research studies meet objectives within established timelines, budgets, and compliance standards.
• Provide training to new staff on study-specific protocols and maintain training documentation.
• Assist in study monitoring visits, audits, and regulatory inspections.
• Coordinate staffing and scheduling to support research study needs.
• Maintain confidentiality of patient data and Protected Health Information (PHI).
• Work collaboratively with provider offices to integrate research efficiently into clinical workflows.
• Manage study supply inventory to ensure protocol compliance.
• Perform additional duties and projects as assigned.

Qualifications

• Bachelor's degree in a relevant field.
• 1-2 years of experience in clinical research.
• Experience in a clinical or medical setting (e.g., medical assistant, nursing assistant, lab technician) or equivalent education, training, and experience.
• Proficiency in Microsoft Office applications.
• Understanding of medical terminology and clinical trial processes.
• Knowledge of GCP/ICH guidelines and FDA regulations related to human subject protection, drug, and device research.
• Familiarity with study protocols, informed consent procedures, and study schedules.
• Competency in clinical procedures such as phlebotomy and vital sign monitoring.
• Strong written and verbal communication skills, including fluency in English.
• Ability to apply research principles and techniques effectively.
• Strong organizational skills with attention to detail.
• Ability to handle multiple priorities and work in a fast-paced environment.
• Strong problem-solving skills and ability to work independently.
• High level of integrity, professionalism, and commitment to confidentiality.
• Ability to build and maintain positive relationships with physicians, team members, and research participants.

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