Research Implementation Coordinator

About the role

Work under the general direction of Department of Medicine research leadership to guide, support, and facilitate the structure necessary for initiating, implementing, and completing research protocols across the Department's research portfolio.

Responsibilities

• Process and procedures coordination: Develop, maintain, and communicate standard operating procedures (SOPs) for teams to utilize across the lifespan of a research project, including onboarding, training, and maintenance of study processes and lab procedures
• Provide faculty with SOPs and programmatic guidance for the start-up needs of new protocols
• Conduct process evaluations across team functions to maintain standardization
• Attend weekly team meetings to ensure consistency and provide real-time feedback for standardization across teams
• Onboarding and training: Create onboarding and training plans in collaboration with the administrative team for new team members
• Lead onboarding sessions for new hires, including program overview, team-specific overview, and role-specific training
• Train study staff, postdocs, fellows, and students on study procedures, SOP requirements, and best practices
• Support the interview team in the hiring of incoming research staff
• Data management: Build, test, and manage REDCap databases and data dictionaries for research studies
• Export and prepare data files for analysis
• Build and maintain enrollment and retention logs and reports for research studies
• Develop and maintain an organized structure for paper file storage
• Set up and monitor randomization; audit and maintain servers for consistency across studies
• Regulatory management: Develop study files needed for IRB approval and apply for IRB approval using the study protocol
• Manage IRB processes from study submission through continuing progress reviews (CPRs), amendments, and termination
• Apply IRB regulatory expectations to data management and study maintenance
• Manage ClinicalTrials.gov processes, including updates, and serve as point of contact
• Perform internal audits to identify structural or regulatory deficits
• Support ticket management and service: Serve as a point of contact for the research implementation ticket system, supporting requests for onboarding, SOP clarification or modification, data management needs, study document changes, new study approval, study amendments, and lab support
• Review incoming tickets for urgency, log requests into the tracking system, and respond to requestors regarding receipt and any additional information needed
• Other duties as assigned

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