Clinical Research Coordinator

Job Summary and Responsibilities We are seeking a Clinical Research Coordinator to join our team! Coordinate and participate in clinical research studies. Responsibilities include collection, compilation, documentation and analysis of clinical research data. Coordinate and implement procedures to collect data from patient charts, medical records, interviews, questionnaires, diagnostic tests and other sources. Coordinate patient care within the multi-disciplinary team. Act as a specialist/resource person; provide support, recommendations and advice to all personnel involved with the study. Able to review minimally necessary data extracts for the purpose of identifying potential research candidates from our patient population. If a potential candidate is identified, they will work with the Primary Physician to begin the consenting process. Participate in various study procedures that may include obtaining blood, tissue or other specimens for laboratory analysis; EKG, echocardiogram, exercise treadmill testing, monitoring devices; and/or cardiac catheterization and interventional procedures. Ensure compliance with protocol guidelines and requirements of the institutional review board (IRB) and FDA regulations. Responsible for preparation of IRB documents, including submission of clinical trial protocols, amendments and study modifications; reporting of serious adverse events; annual reports; and/or study closure. Ensuring all personnel associated with the implementation of clinical trials are adequately educated to the disease process, protocol requirements, special procedures, therapeutic treatment and technological devices through group or individual education meetings. Ensure patient/subject participant safety by actively exercising the patient advocacy role and implementing the ongoing process of informed consent to ensure patient's confidentiality and autonomy is maintained. Ensure that the subject fulfills the inclusion/exclusion criteria to enter the study. Monitor for outcomes/endpoints related to the clinical protocol procedures. Evaluate and interpret collected data in conjunction with the principal investigator(s) as appropriate; prepare presentations or written reports and analyses. Assist the principal investigator in developing plans for research projects and collaborate on the preparation of manuscripts for publication. Data collection responsibilities include: maintenance of clinical trial regulatory files; maintenance of computer, paper and filing systems for the recording updating and reporting of data; and preparation of study documents (screening and enrollment records, case report forms, queries). Maintain study budget and financial records, if required. Negotiate study budget and site costs by ensuring that the cost for all study tests/procedures are adequate and included in the study agreement. Manage budgets effectively. Ensure trials are maintained within the study budget and accurate payments are received. Ensure that ancillary departments are paid for services provided. The job summary and responsibilities listed above are designed to indicate the general nature of the work performed within this job. They are not designed to contain or be interpreted as a comprehensive inventory of all job responsibilities required of employees assigned to this job. Employees may be required to perform other duties as assigned. Job Requirements Bachelor’s (or equivalent) in a related field upon hire. Three years clinical research experience required. #J-18808-Ljbffr CommonSpirit Health