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This position applies scientific knowledge to coordinate a significant research projects within the Partnerships for Native Health program at the Initiative for Research and Education to Advance Community Health (IREACH) at a field site located in Phoenix, AZ. Exercises considerable day-to-day independence to develop and implement study protocols, materials, and procedures.
The incumbent will manage all phases of research studies, working from grant applications to design approaches and methodologies to achieve specific aims and to design specific phases of research projects. The incumbent will write Institutional Review Board (IRB) applications and be responsible for compliance throughout the study. The incumbent will also execute all study procedures (and direct others in the execution of study procedures), including conducting participant study visits, designing and overseeing data collection, conducting analyses, and preparing reports for publication. The incumbent will seek consultation from project Principal Investigator (PI) and senior staff, but will generally be expected to utilize substantial research experience to exercise independent judgement in day-to-day decision making and project oversight.
Study Design and Data Management – 40%
Develops project research alternatives if the project research is not compatible with program goals or participating community environment.
Designs methodology and specific phases of the research projects to achieve stated specific aims.
Re-designs research methodology when established methodology is not working. Collaborates with the PI to re-design methods. Presents re-design to PI for approval.
Manages the site specific cultural adaptation process for the research
Identifies, defines and solves research method and project implementation problems in weekly reports on study progress prepared for PI and project lead.
Creates and maintains a strategy for tracking research subjects, and training and supporting others in utilizing these collection and tracking systems, and communicates these strategies to research staff and community and tribal partners.
Reviews and assesses study data to ensure adherence to study protocol and compliance with IRB regulations. Collaborate with the PIs/Scientific Operations Manager if protocols are not being met.
Develops research designs, data collection methods, and strategies for managing computerized data collection systems, including building and maintaining databases, and directing quality assurance and data cleaning efforts.
Manages and organizes data collection efforts for research projects, which may include other collaborating with other agencies or institutions, and verifies accuracy of research data.
Establishes and manages, in collaboration with IREACH data manager, the tracking of research subject completion of research activities, onsite data storage and data transfer system ensuring data security and prompt transfer.
Conducts internal audits of data and participant documents to be shared between the investigator and study sponsors, IRB, and other relevant governing bodies and partners, including Native communities, tribal colleges and universities, and clinical providers.
Collaborates with analysts and investigators to develop resources and procedures for data collection. Exercises independence to design processes for data collection and management, leveraging considerable knowledge of these requirements.
Prepares and delivers weekly reports on study progress to PI and project lead.
Analyzes data to provide summary reports and presentations.
Human Subjects Management and Research Coordination – 25%
Provides oversight and supervision over study procedures for recruitment, data collection and study intervention reports, and provides updates to PIs and supervisor. Troubleshoots problems as they arise and address protocol deviation with IRB coordinator and Pl.
Creates study-specific compliance applications, amendments, renewals, informed consent documents and study protocols, and directs staff and PI compliance with policy and procedure concerning human subjects.
Reviews and assesses study data and utilizes study data to prepare presentations for regional and national meetings.
Collaborates in the development of the project manual of operations. Creates study-specific compliance applications, amendments, renewals, informed consent documents and study protocols, and directs staff and PI compliance with policy and procedure concerning human subjects.
Exercises independent judgment to address questions, concerns, and complaints from faculty, staff, community partners, and the public that are escalated from the Research Study Coordinator(s).
Writes manuscripts for publication and presentation summarizing study findings. Collaborates with others, as needed, when writing and developing manuscripts.
Manages informed consent process. Ensures all study participants are informed of the study, procedures, and confidentiality. Provides informed consent policies to study participants.
Works closely with co-investigators to appropriately manage participant problems and concerns. Takes initiative to resolve participant problems and addresses concerns.
Study Budget and Grant Management – 15%
Addresses issues concerning budgets and subcontracts as they arise, maintaining and reconciling study budgets as money is allocated and spent.
Writes, edits, and oversees preparing progress reports to funders and proposals, as needed.
Coordinates reimbursement for study participation and billing procedures related to study visits.
Prepares documents for granting agencies and renewal, interpreting data and guiding future research.
Supervision – 15%
Directs the daily responsibilities of field staff, ensuring compliance to protocol and IRB regulations, providing support, as needed, and coordinating all logistical efforts. Leads scheduled weekly meetings with field staff via telephone or video conference.
Supervises and evaluates the performance of field staff, assigning work and following up to ensure completion. Provides direction as needed.
Travels, as needed, to study sites to train and direct field staff project procedures and file management, to resolve problems and to conduct project management activities with partners such as project presentation, subcontract management, and to undertake support study findings and data dissemination efforts.
Trains field staff on protocols to ensure confidentiality of participants and data.
Other – 5%