Associate Clinical Study Coordinator

Associate Clinical Study Coordinator

Requirements

• Associates or Bachelor’s degree in a life science (ex. biology, biomedical, nursing, microbiology, psychology)
• At least 1-2 years of experience documenting or recording information in a clinical research, laboratory or quality assurance environment OR providing direct patient care in a healthcare environment
• Knowledge of ICH and GCP guidelines
• Strong communication skills
• Attention to detail
• Experience using time management skills such as prioritizing/organizing and tracking details and meeting deadlines of multiple projects with varying completion dates
• Independent/self-directed/problem solving-solutions oriented

Responsibilities

• Participates as needed in Internal study protocol development and Institutional Review Board submissions as well as collaborates with other Clinical Operations team members to create any needed study tools and documents
• Conduct Internal clinical trials executed at Medline Industries, LP in accordance with ICH (International Committee for Harmonization), GCP (Good Clinical Practices) guidelines, and departmental and Medline Industries, LP. SOPs (Standard Operating Procedures)
• In coordination with Principle Investigator (PI), recruit study participant, ensure understanding of participation requirements, and any possible risks or benefits of the study. Main point of contact for study participant
• In coordination with primary CRA and PI, plans all study execution activities, study product procurement and accountability management, any necessary training for protocol execution, execution practice sessions, and resource management
• Ensure all protocol and procedures are followed. Gather, communicate problems (ex. protocol deviations), and determine best course of action
• Execute delegated protocol study activity including participant pre-screening and screening activity, participant scheduling, monitor study participant safety throughout the trial, and coordinate communications between other members of the clinical research team
• Accurately documents (on paper or in electronic systems) all clinical study activities and data collection. Maintains records in coordination with established document management processes and in collaboration with Clinical Trial Coordinators (CTC/Sr. CTC)
• Provides Clinical Affairs and Medical Affairs ongoing study status updates
• Ensure compliance with local and federal law and research regulations/guidance

Preferred Qualifications

• Bachelor’s degree in a life science (ex. biology, biomedical, nursing, microbiology, psychology)
• 2-4 years of experience in a clinical research role with exposure to ICH and GCP guidelines
• Exposure to CTMS, EDC (Electronic Data Capture), and eTMF