Clinical Research Coordinator

Benefits

Qualifications

• •At least 2 years of relevant work-related experience in the medical field
• •Knowledge of “good clinical practices” for clinical research as defined by the Code of Federal Regulations (CFR)

Responsibilities

• •The Research Coordinator is primarily responsible for coordinating research patient visits according to both the ICH-GCP guidelines and the IRB-approved study protocol and/or manual of procedures
• •Day-to-day activities may include all or some of the essential functions listed below, depending upon individual experience / knowledge and the needs of the organization which are subject to change from time to time
• •Primary responsibility is to screen, enroll and follow study subjects ensuring protocol compliance and monitoring while the subjects are on study
• •Responsible for all data collection, source documentation, completing study specific case report forms, and submission of adverse experience reports
• •Maintains accurate and complete records including regulatory documents when applicable, signed informed consent forms, source documentation, subject logs and study-related communications
• •Schedule subjects in protocol defined windows
• •Go through the consent form with patients and ensure that they understand and sign ICF prior to any study related procedures
• •Perform ratings scales that you have been trained on
• •Communicate with sponsors and CROs and reviews and responds to any monitoring findings and escalates issues
• •Make IRB submissions in collaboration with the regulatory coordinator (Continuing reviews, SAEs, protocol deviations, and other when required) and maintain IRB binder
• •Resolve queries in a timely manner and be capable of entering data into the EDC if assistant is not available to do so
• •Communicate with PI regarding trial requirements, safety evaluations, regulatory, and monitoring
• •Ensure that the PI signs off on labs, AEs, and ECGs in a timely manner
• •Ensure all regulatory binders are up to date
• •Recruit patients via research database, ad campaigns, and MD-MD letters
• •Phlebotomy and ECGs
• •Understand disease states
• •Dispense IP and perform accountability
• •Communicate with vendors
• •Communicate with patients and caregivers
• •17 more items(s)