Clinical Research Coordinator II (CRC)

Job Description Job Description This position is responsible for performing highly diverse clinical and administrative responsibilities requiring a high level of knowledge and attention to detail. This position requires assimilating vast amounts of information and processing information promptly and orderly. Personnel who fill this role must have a working knowledge of ICH/GCP guidelines. Specific studies are assigned as appropriate, and the coordinator is accountable to the Principal Investigator, Medical Director, and Clinical Research Manager. Qualifications 1+ years of previous experience required as a clinical research coordinator for pharmaceutical phase II or III trials, GI trials Computer skills - Microsoft Word, Excel, PowerPoint, CTMS, EMR Previous experience in a role of complex administration or project coordination Effective communication skills, including written, verbal, and presentation skills Strong attention to detail and organizational, analytical, and problem-solving skills Periodic local travel to other practice locations on an as-needed basis Supervisory Responsibilities This position may serve a role in supporting/ mentoring junior coordinators and research assistants Job Duties/Responsibilities Ensure the rights, safety and welfare of all subjects at all times Ensure that each subject goes through the informed consent process following GCP guidelines, and consents to participate, before any study-related procedures are performed Work in a collaborative, effective manner with the Sponsor personnel to meet research objectives completely and accurately Work in a collaborative, effective manner with Site personnel to meet research objectives completely and accurately Responsible for understanding all internal policies and procedures approved by the Principal Investigator/Medical Director Discuss study protocols with patients and verify informed consent documentation Review patient medical history against Inclusion/Exclusion Criteria of studies Perform blood draws, process and shipping of blood/urine specimens per study protocol and IATA regulations Schedule all patient research visits and procedures consistent with protocol requirements Dispense study medication, collect vital signs, and perform ECGs Assist with routine data verification and quality control, ensuring data integrity and consistency with the prescribed study protocol Provide the Sponsor with accurate and complete documentation and information Provide accurate and complete documents for IRB submission on a timely basis Complete and maintain accurate, legible and complete source documents and case report forms per FDA guidelines and Sponsor requirements Retain and/or forward copies of forms as required by the Sponsor Inform Sponsor of prospective FDA audits immediately Prepare for FDA or Sponsor audit by ensuring all documentation and case report forms are available and complete Provide subject education on an ongoing basis throughout their participation in the study Report all adverse events to the Investigator, Sponsor and IRB. Complete Study Logs in an accurate and timely manner in the appropriate electronic data system Utilize a team approach including the PI, Sub-Investigators, other Coordinators and Research Assistant Assist in the training of new staff members Other duties as assigned #J-18808-Ljbffr 6AM City, LLC