Research Coordinator

Responsibilities

• Captures and coordinates clinical research activities for the ARJR service under the direction of the Industry Director, Clinical Research
• Serves as a liaison between the PIs/Sub-Is, Sponsors, CROs, Service Research Leadership, and other research staff to ensure protocol adherence and study efficiency
• Supports all phases of study conduct including feasibility, start-up, activation, enrollment, follow-up, monitoring, and close-out activities
• Contributes to all aspects of ARJR industry research including:
• Assisting with protocol development and informed consent forms
• Recruitment and Enrollment process (conducts pre-screening, eligibility assessments, and informed consent process under PI supervision)
• Schedules and coordinates research study visits, facilitates completion of study procedures and assessments; Maintains real-time subject calendars and study tracking logs throughout study lifecycle to ensure visit adherence and completion of protocol requirements
• Maintains and tracks reportable events including adverse events (AEs/SAEs), protocol deviations, device issues, and unanticipated problems under PI supervision; promptly notifies PI of potential AEs/SAEs for review and reconciliation and ensures timely Sponsor/IRB reporting and documentation maintenance
• Ensures that all research related regulatory, institutional, and departmental compliance requirements are met as appropriate
• Facilitates completion and submission of all documentation needed for research (e.g., IRB applications, amendments, reportable events, continuing reviews to ensure study renewals, conflict of interest forms, data collection forms, etc.)
• Facilitates completion and submission of Enrollment Milestones and invoiceable items via CTMS SMART for billing reconciliation; ClinicalTrials.gov registration, updates, and results reporting, in compliance with federal and institutional requirements
• Maintains complete and audit-ready regulatory binders, including delegation of authority logs, training records, all IRB, Sponsor, and FDA correspondence
• Maintains and enhances professional growth through participation in seminars, professional affiliations, and internal training sessions to keep abreast of trends in the field of clinical research project management

Requirements

• Bachelor’s degree required, Masters preferred
• 2+ years of experience in clinical research required; ACRP or SOCRA Certified Clinical Research Coordinator (CCRC) or Certified Clinical Research Professional (CCRP) preferred
• Prior experience with REDCap / EHRs (e.g., EPIC) / Electronic Data Captures, IRB Management platforms
• Knowledge of Human Subjects research regulations and HIPAA compliance; FDA regulations for clinical trials; Good Clinical Practice
• Prior experience with Orthopaedic and/or Rheumatologic terminology is preferred