Franciscan Health Indianapolis Campus 8111 South Emerson Avenue Indianapolis, Indiana 46237 WHO WE ARE 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 that provide compassionate, comprehensive care for our patients and the communities we serve. WHAT YOU CAN EXPECT 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. Monitor protocol deviations and violations, and report events to the research sponsor according to written protocols and departmental standards. Participate in site initiation visits by scheduling and documenting training of site research staff. Report events to the research administration and IRB according to written policies and procedures. Respond to and resolve data queries in accordance with Sponsors’ and Department’s written standards. Review written research protocols and provide input on logistical issues prior to implementation. QUALIFICATIONS High School Diploma required Associate Degree preferred 1 year of Healthcare Administration(Business), Nursing/Patient Care, or Research Administration experience preferred TRAVEL IS REQUIRED: Never or Rarely EQUAL OPPORTUNITY EMPLOYER It is the policy of Franciscan Alliance to provide equal employment to its employees and qualified applicants for employment as otherwise required by an applicable local, state or Federal law. Franciscan Alliance reserves a Right of Conscience objection in the event local, state or Federal ordinances that violate its values and the free exercise of its religious rights. Franciscan Alliance is committed to equal employment opportunity.