Clinical Research Coordinator

Clinical Research Study Coordinator

Classification FSLA – Non-Exempt/Hourly

Salary Grade/Level/Range Level of experience, longevity, certification, within company pay structure

Reports to: Clinical Infusion and Research Manager

Summary/Objective

The Clinical Research Study Coordinator is responsible for the day-to-day coordination and management of clinical research studies conducted within the neurology infusion center. This role ensures protocol adherence, accurate data collection, regulatory compliance, and effective communication between investigators, sponsors, CROs, clinical staff, and patients.

The Study Coordinator supports study start-up, participant screening and enrollment, visit coordination, data management, and regulatory documentation to ensure high-quality research execution and patient safety.

Work Environment

This position operates in a medical infusion and research center and routinely uses computers, EMR systems, electronic data capture (EDC) platforms, phones, and standard office equipment. Interaction with patients, clinical staff, providers, and external research partners is routine.

Essential Functions

Study Coordination & Execution

• Coordinate assigned clinical research studies from start-up through close-out
• Screen, recruit, and enroll eligible research participants according to protocol criteria
• Schedule and coordinate study visits, procedures, infusions, labs, and follow-ups
• Ensure protocol-specific procedures are completed accurately and within required timelines

Study Start-Up & Regulatory Support

• Assist with study start-up activities, including feasibility assessments, site readiness tasks, and workflow development
• Prepare and maintain regulatory documents including investigator site files (ISFs), delegation logs, training logs, and essential documents
• Support IRB submissions, amendments, renewals, and continuing reviews as directed
• Ensure staff training documentation is current and protocol-specific training is completed

Data Management & Documentation

• Accurately collect, enter, and maintain study data in EDC systems and source documents
• Ensure data accuracy, completeness, and timeliness in compliance with GCP and protocol requirements
• Respond to data queries and collaborate with monitors and sponsors during monitoring visits
• Maintain organized and audit-ready study documentation

Clinical & Operational Collaboration

• Collaborate closely with infusion nurses, providers, and research leadership to coordinate study-related care
• Communicate effectively with sponsors, CROs, and monitors regarding study progress and issues
• Assist with investigational product accountability, documentation, and coordination with pharmacy or nursing staff as applicable

Patient Education & Support

• Educate study participants on protocol requirements, visit expectations, and study procedures
• Serve as a primary point of contact for research participants throughout study participation
• Ensure participant safety, confidentiality, and informed consent compliance at all times

Compliance & Quality

• Ensure compliance with study protocols, GCP guidelines, HIPAA regulations, and institutional policies
• Maintain confidentiality of patient and study information
• Assist with monitoring visits, audits, and inspections as required
• Identify protocol deviations and escalate concerns to research leadership

Daily / Ongoing Responsibilities

• Track study milestones including enrollment, visits, and follow-ups
• Maintain study calendars and visit schedules
• Assist with ordering and tracking study supplies and materials
• Perform assigned clerical duties including filing, scanning, copying, and data organization
• Support infusion and clinical teams with research-related coordination needs

Physical Demands

• Work involves sitting, standing, and walking throughout the day. Visual acuity, auditory acuity, and manual dexterity are required for data entry and documentation. Minimal lifting may be required.

Position Type/Expected Hours of Work

• Full-time position. Typical hours are Monday through Friday. Evening hours may be required based on study or operational needs.

OSHA Exposure Classification:

• Job Category I. Direct contact with blood or other body fluids (Bloodborne Pathogens) to which Universal Precautions apply. Personal protective equipment is made available and must be worn.

Travel

• Travel may be required to satellite infusion or research locations or for sponsor meetings and training.

Required Education and Experience

• Associate's or Bachelor's degree in a health-related or science field preferred
• Prior experience in clinical research coordination preferred
• Knowledge of GCP, IRB processes, and clinical research regulations preferred
• Experience with EMR and EDC systems preferred
• Strong organizational, communication, and documentation skills

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.