Job Description
Franciscan Health Indianapolis Campus 8111 S Emerson Ave Indianapolis, Indiana 46237 The Clinical Research Coordinator I provides data or regulatory support to the clinical research teams and principal investigators. The position is responsible for either 1) the study regulatory submissions and management or 2) the clinical data submissions and management. WHO WE ARE Franciscan Health is a leading healthcare organization dedicated to providing exceptional patient care and promoting health and wellness in our community. Our mission is to ensure that every patient receives the highest quality of care through innovation, compassion, and excellence. With 12 ministries and access points across Indiana and Illinois, Franciscan Health is one of the largest Catholic health care systems in the Midwest. Franciscan Health takes pride in hiring coworkers who provide compassionate, comprehensive care for our patients and the communities we serve. WHAT YOU CAN EXPECT Schedule: Monday - Friday, 8am - 5pm Abstract data and complete Case Report forms in accordance with Sponsors' and Department's written standards. Prepare for and participate in monitoring and auditing activities including scheduling, document preparation, and issue resolution. Complete initial regulatory paperwork including required essential documents, submissions to the research administration, and submissions to the IRB, according to institutional policies and departmental standards. Complete regulatory requirements for changes in research including submission to the research administration, submission to the IRB, and communication to the research team, according to institutional policies and departmental standards. Maintain accurate records of monitoring activities on clinical trials where data submission and/or review is related to payment milestones. <