Clinical Research Coordinator

Clinical Research Coordinator

Position Summary

The Clinical Research Coordinator is responsible for the day-to-day management and execution of clinical research studies within an independent gastroenterology practice. This role ensures compliance with regulatory requirements, supports patient recruitment and retention, and coordinates study activities to maintain high-quality data and patient safety.

Key Responsibilities

Study Coordination & Management

• Coordinate all aspects of clinical trials from startup to closeout
• Maintain study protocols, regulatory documents, and investigator files
• Ensure compliance with FDA, GCP (Good Clinical Practice), and IRB requirements
• Liaise with sponsors, CROs, and study monitors

Patient Recruitment & Care

• Identify and recruit eligible patients for gastroenterology studies (e.g., IBS, IBD, liver disease)
• Obtain informed consent and explain study procedures to participants
• Schedule and conduct study visits, including follow-ups
• Monitor patient safety and report adverse events

Clinical & Data Responsibilities

• Collect, document, and maintain accurate study data in EDC systems
• Perform basic clinical procedures (vitals, specimen collection/processing, EKGs if applicable)
• Ensure proper handling, storage, and shipment of lab specimens
• Prepare for and participate in monitoring visits and audits

Regulatory Compliance

• Prepare and submit regulatory documents to Institutional Review Boards (IRBs)
• Maintain essential regulatory binders and study documentation
• Ensure adherence to HIPAA and patient confidentiality standards

Administrative Duties

• Track study timelines, enrollment metrics, and budgets
• Assist with contract and budget coordination as needed
• Maintain inventory of study supplies and investigational products

Qualifications

Education & Experience

• Bachelor’s degree in life sciences, nursing, or related field preferred
• 1–3 years of clinical research experience (gastroenterology preferred)
• Experience in a private practice or outpatient setting is a plus

Certifications (Preferred)

• Certified Clinical Research Coordinator (CCRC) or equivalent

Skills & Competencies

• Knowledge of gastrointestinal conditions and treatments
• Familiarity with EDC systems and clinical trial software
• Strong organizational and multitasking skills
• Excellent communication and patient interaction abilities
• Attention to detail and ability to maintain accurate records

Work Environment

• Outpatient gastroenterology clinic setting
• Combination of patient-facing and administrative responsibilities
• Standard weekday hours with occasional flexibility based on study needs

Qualifications

Education & Experience

• Bachelor’s degree in life sciences, nursing, or related field preferred
• 1–3 years of clinical research experience (gastroenterology preferred)
• Experience in a private practice or outpatient setting is a plus

Certifications (Preferred)

• Certified Clinical Research Coordinator (CCRC) or equivalent

Skills & Competencies

• Knowledge of gastrointestinal conditions and treatments
• Familiarity with EDC systems and clinical trial software
• Strong organizational and multitasking skills
• Excellent communication and patient interaction abilities
• Attention to detail and ability to maintain accurate records