Direct supervision of the research team including management of the workload distribution and prioritizationProject management for studies o Development of informed consents/assents both for local use and as templateso Conduct protocol related training for study coordinators and co-investigators internally at the University of Michigan.o Monitor study activities for recruitment, retention, data quality, and regulatory compliance. Regulatory management includes consent form review and ensuring that IRB approvals are current o Ensure compliance with protocols, quality control, data completion, and submission of study related documentation to the appropriate reporting agencies including external sponsors and the IRB. o Study FeasabilityData cleaning, report generation, review and interpretation of results Prepare IRB submissions including initial submissions, amendments, and adverse event reporting Recruitment and consent of study participants.Data collection and data entry into electronic databases Collect, process, label and store biospecimens including blood, urine, and sputum samples Oversight of Port CF Outcome databaseSOP developmentAssist budget developmentFinancial management including: creation/negotiation industry budgets, monitoring expenses and invoicing, and staff effort management. Act as a liason between other departments and sponsor with the PIEnsures accurate, ethical, and appropriate management of patients in compliance with all institutional and federal regulations.Completion of study visitsCompletion of ECRFCollect and process specimensMaintain inventory and equipmentParticipate in research related conferencesTrains and mentors staffSupervision of research staffTakes a lead role and/or coordinates or presents at internal/external clinical research education event/conference

Coordinate and execute designated clinical trial experiments, including procurement of space, supplies, and related equipment; recruitment of patients, screening of patients, study article dispensing, blood sample collection, study article dispensing, data analysis/processing and diagnostic and therapeutic interventions. Manage all patient research data; prepare appropriate reports for investigators and/or sponsors including maintaining and completing the supplied case report forms; project reports as required by the sponsor. Manage and coordinate: data related to participation in studies, work flow as needed by multiple studies. Participate in conferences related to the project and /or its progress. Act as liaison between patients, investigators, other departments, sponsors, vendors and regulatory agencies. Coordinate recruitment of patients for interventional trials and patient education relative to study participation. Participate in the development of general goals for the research project and in the planning of the field work; plan and coordinate the work of students and other support personal; prepare and maintain regulatory documents, IRB applications, informed consents and assents; interact with investigators and staff to facilitate study initiation procedures, study close-out and monitoring activities. Internal monitoring of study protocols. Facilitate Federal Drug Administration Investigations, Maintaining of CF center registry.