Clinical Research Coordinator II Job Details Job Location Presbyterian Hospital of Dallas/DCPM - Dallas, TX Description Urology Clinics of North Texas strives to provide highly positive medical outcomes, proven advanced technology and pharmaceuticals. We deliver care in locations convenient to patients throughout the Dallas, Collin, Rockwall, and Tarrant County areas. The 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. This position is open to candidates with 3-5 years of hands-on experience working on clinical trials. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES INCLUDE:(Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions): + Facilitate and coordinate the daily cancer clinical trial activities + Work directly with on-site research staff of Investigators, Nurses, Medical Assistants. + Other duties within the scope of a Clinical Research Coordinator + 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 + Coordinate clinical trials per Good Clinical Practice and CFR guidelines + other duties, as assigned by the manager/supervisor 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 AND 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. Job Type: Full-time Benefits: + 401(k) + Dental insurance + Health insurance + Life insurance + Paid time off + Vision insurance Medical Specialty: + Urology Schedule: + Monday to Friday + No weekends Work Location: In person Qualifications Urology Clinics of North Texas strives to provide highly positive medical outcomes, proven advanced technology and pharmaceuticals. We deliver care in locations convenient to patients throughout the Dallas, Collin, Rockwall, and Tarrant County areas. The 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. This position is open to candidates with 3-5 years of hands-on experience working on clinical trials. ESSENTIAL FUNCTIONS AND RESPONSIBILITIES INCLUDE:(Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions): + Facilitate and coordinate the daily cancer clinical trial activities + Work directly with on-site research staff of Investigators, Nurses, Medical Assistants. + Other duties within the scope of a Clinical Research Coordinator + 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 + Coordinate clinical trials per Good Clinical Practice and CFR guidelines + other duties, as assigned by the manager/supervisor 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 AND 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. Job Type: Full-time Benefits: + 401(k) + Dental insurance + Health insurance + Life insurance + Paid time off + Vision insurance Medical Specialty: + Urology Schedule: + Monday to Friday + No weekends Work Location: In person