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Clinical Research Coordinator II

4 months ago

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Clinical Research Coordinator IIJob DetailsJob Location Presbyterian Hospital of Dallas/DCPM - Dallas, TX Position Type Full Time Job Shift Day Job Category Health Care Description Clinical Research Coordinator (CRC) II comprises an integral part of the research team. Working under the PI, he/she is responsible for conducting the study in accordance with federal and hospital regulations. Some responsibilities of the Clinical Research Coordinator (CRC) II depending on need include: + Facilitate and coordinate the daily cancer clinical trial activities + Coordinate clinical trials per Good Clinical Practice and CFR guidelines + Work directly with on-site research staff of Investigators, Nurses, Medical Assistants. + Accurate and timely trial data collection and reporting + Submit regulatory documents to IRB and Sponsor + Attend investigator meeting(s) + Obtain physician and staff signatures + Recruit subjects/patients + Screen, track and schedule trial pts + Coordinate the Informed Consent Process, ensuring all patients are properly consented prior to initiating clinical trial procedures + Teach subjects/patients about protocol expectations for trial visits + Perform study/protocol procedures in a detailed, accurate manner + Maintain study files completely and accurately + Report all adverse events and SAEs within required timelines + Collect laboratory specimens, process/ship lab work + Maintain communication and correspondence (by telephone, email, fax, etc.) with subjects, sponsor, monitor and other site study personnel. + Complete case report forms (CRF) and electronic data capture (EDC) for PI review and approval + Respond to all data queries and sponsor requests in a timely manner + Coordinate site study monitor and sponsor visits + Maintain study-specific supplies + Prepare for study closure and archiving + Maintain appropriate training required to carry out protocol-driven activities as delegated by the PI + Other duties within the scope of a Clinical Research Coordinator Qualifications Job Qualifications: + 3-5 years of equivalent experience in medical clinic, research coordination required + CCRP, ACRP certification preferred but not required + Prior experience with Urology and Oncology clinical trials preferred + Performs primary duties with greater independence and has progressed to performing more advanced skill sets as directed. + Some EMR (electronic medical records) experience required + Some Electronic Data Capture (Rave, Oracle, Inform, etc.) experience required Knowledge, Skills & Abilities: + Excellent organization and communications skills required. + Strong interpersonal skills ability to effectively interact with all levels of staff and external contacts. + Must be detail oriented and have the ability to follow-through. + Ability to effectively manage time and prioritize workload. + Must practice discretion and always adhere to site confidentiality guidelines. + Knowledge of medical terminology (Oncology and Urology preferred). + Knowledge of good clinical practice, FDA, OHRP, HIPAA policies. + Proficiency with the Microsoft Office Suite, Google Docs, SharePoint.