Clinical Research Coordinator II

About the role

The Clinical Research Coordinator II is a high-autonomy role that supports clinical research accessibility and administers administrative support to the clinic. This role works closely with the Principal Investigator (PI) to ensure study enrollment meets or exceeds inclusion/exclusion criteria, conducts patient visits, collects data, reports adverse events, and maintains compliance with all study protocols.

Responsibilities

• Works with PI to meet or exceed study enrollment as per Sponsor’s inclusion/exclusion criteria
• Completes feasibility questionnaires and regulatory start-up packages
• Recruits and enrolls patients, screening for eligibility criteria
• Conducts patient visits, collects data, and follows up with subjects
• Reports and tracks adverse events, protocol waivers, deviations, and violations
• Ensures compliance with study protocol, SOP, and reporting requirements
• Completes and enters data into study-specific forms and electronic data capture systems
• Handles and records specimens, prepares shipments, and tracks inventory and calibrations
• Attends meetings, responds to audits, and communicates with stakeholders
• Trains, mentors, and guides less experienced coordinators and clinic staff
• Manages day-to-day research operations with minimal oversight
• Operates clinic efficiently, maintaining inventory, supplies, and equipment
• Keys data into EMR/forms, schedules patients, and handles administrative tasks
• Communicates with patients, families, ancillary departments, and physicians
• Performs routine administrative tasks and adheres to company policies and procedures
• May travel to multiple clinics within a reasonable driving distance

Qualifications

• High school diploma required; Bachelor's degree in a health science or related field preferred
• Minimum of 2-3 years of clinical research coordinator experience at an investigational site required
• Experience at a smaller or independent site network, with broad ownership across regulatory, recruitment, data, and monitoring-visit functions, strongly preferred
• Prior experience training, onboarding, or mentoring other coordinators preferred
• Certification (e.g. CCRC via ACRP or CCRP via SOCRA) a plus
• Phlebotomy certificate preferred
• Current Medi-Waste Training for: Bloodborne Pathogens for Healthcare, GHS Hazcom, HIPAA, HITECH & Omnibus
• Proficient use of EMR and CTMS systems within 2 weeks
• Effective use of computerized patient care system, knowledge of medical terminology, strong interpersonal skills, and proficiency in Microsoft Office (e.g. Office, Excel, Word)