Clinical Research Coordinator I - Orthopedic Surgery-24760

Responsibilities

• Recruits, consents, screens, schedules, tracks and provides study updates to study participants throughout the conduct of the study.
• Collections and enters data into study case report forms and/or electronic data capture system and responds to queries in a timely manner.
• Affords assistance in preparing simple data summaries, reports, or charts to support study documentation and reporting requirements.
• Maintains accurate and complete procedural documentation including study participant and site level documentation in compliance with institutional, local, state and federal guidelines and regulations related to clinical research.
• Verifies data against 100% of source documentation for accuracy before entry into case report forms and electronic data capture systems to ensure timeliness and audit readiness.
• May collect, process and ship potentially biohazardous specimens.
• Administers structured tests and questionnaires according to research study protocols.
• Utilizes study-related technology and equipment as part of assessment procedures.
• Provides ongoing study status updates and responds to questions from PI, Administrator, department stakeholders, Sponsor and Compliance throughout the conduct of the study.
• Communicates promptly with study participants and coordinates with study team members as directed.
• Participates in auditing and monitoring visits.
• Gathers and communicates unanticipated problems (protocol deviations, adverse events, and serious adverse events).
• Works with PI(s), sponsor, compliance, clinical staff and/or manager to identify and improve routine processes as it relates to the conduct of the research study.

Qualifications

• Required: Bachelor’s degree.
• Preferred: Two (2) or more years prior experience in clinical research or related field.