Coordinator, Research Projects

We are recruiting for a motivated Coordinator, Research Projects to join our team!

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Department

ED Administration

Under minimal supervision, the Research Project Coordinator will work collaboratively within the Department of Emergency Medicine to contribute to the scientific development, planning, implementation, and execution of clinical research protocols. The Department of Emergency Medicine at Denver Health includes a highly-integrated research team that is strongly committed to performing practice changing, high quality original research. The research portfolio currently includes approximately $8 million of extramural funding, and includes investigator-initiated grants as well as participation in large national research networks (e.g., Prevention & Early Treatment of Acute Lung Injury [PETAL], Strategies to Innovate Emergency Care Clinical Trials Network [SIREN], Linking Investigations in Trauma and Emergency Services [LITES]). The Research Project Coordinator will lead the research process and oversee research staff to ensure project goals and objectives are met in a high quality and timely fashion. The Research Project Coordinator will manage the day-to-day operations of project-related activities, and will work closely with the Sponsored Programs and Research Office (SPARO), the research team, and investigators, as appropriate to ensure timely and accurate progress on assigned projects. Also, the Research Project Coordinator will collaborate with other Denver Health departments, external local and national research sites, and within national research networks to carry out research projects. He/she will also manage and oversee all regulatory submissions originating in the Department of Emergency Medicine, supervise and mentor Research Assistants, and provide broad research support to the Department as outlined below.

Essential Function

.  Project/Protocol Management

• Assist with design and development of research proposals and protocols in conjunction with the study team
• Lead IRB and all regulatory requirements and submissions for assigned research projects
• Monitor and ensure compliance with all appropriate regulatory requirements applicable to different studies
• Responsible for implementation and ongoing oversight of project logistics including laboratory and pharmacy, and Coordinating Centers, when appropriate
• Identify, screen, consent, enroll participants, and provide oversight of enrollment by research assistants

• Administer study drug/procedures as outlined in research protocols
• Forecast study supply needs, including project resources and investigational product
• Prospectively identify issues and troubleshoot protocols in collaboration with the research team
• Work cross-functionally with multiple departments within and outside the organization to facilite project completion and quality oversight
• Oversee data collection and verification including communications/queries with co-investigators and sub-contractors as required for project
• Internal project audits, preparation for external audits, development and implementation of quality control processes
• Budget tracking and invoicing/payment oversight for assigned projects
• Supervise staffs’ (e.g., research assistants) daily activities, provide training and mentorship as appropriate, and oversee general performance

2. Departmental Regulatory Management and Oversight

• Responsible for preparation, submission, and regulatory oversight for all new and on-going IRB applications for all funded and unfunded research projects in the Department
• Maintain current knowledge in rules and regulations relevant to clinical trial and study conduct and oversight (CFR, OHRP, ICH and COMIRB) as they relate to on-going departmental projects, new IRB submissions, and funding applications

• Create and maintain departmental regulatory binders and documents

. Departmental Research Support

• Assist faculty, fellows, and residents in the design, development, approval, and execution of research protocols
• Evaluate and disseminate new requests for applications (RFAs), requests for proposals (RFPs), and other research-related opportunities to faculty based on research interests

• Assist with grant application submissions
• Develop and maintain departmental research website
• Assist with manuscript preparation
• Course Coordination for EMED 8600 “Re