Manager, Research Support

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1. Regulatory & Protocol Management:

• Oversee all regulatory documentation and protocol implementation for the ECHO study.
• Collaborate with the PI to maintain the regulatory binder, site-specific SOPs, and IRB submissions (local and external).
• Monitor and ensure the timely implementation of ECHO change memos and protocol updates.
• Maintain up-to-date training documentation and certification records for all study personnel.
• Ensure compliance with NIH, UM, and external regulatory requirements.

2. Compliance & Reporting:

• Ensure ongoing compliance with NIH regulations, IRB requirements, Good Clinical Practice (GCP), and institutional research policies.
• Prepare and submit annual progress reports, continuing review applications, and other documentation required by the NIH, University of Miami, and relevant oversight bodies.

3. Liaison & Communication:

• Serve as the primary liaison between the ECHO Coordinating Center and the local cohort site.
• Communicate updates related to IRB changes, protocol amendments, data implementation strategies, and operational guidelines.
• Coordinate and disseminate key information to ensure alignment between the local team and national ECHO partners.

4. Research Coordination & Oversight:

• Supervise the documentation, filing, and secure handling of participant source documents.
• Meet regularly with the PI, research team, and project leadership to ensure progress toward study milestones and deliverables.
• Support manuscript development, including writing, formatting, and submitting publications in collaboration with the PI.

5. Meeting Participation & Collaboration:

• Attend all required ECHO meetings at both the local and national level, including but not limited to:
  • Monthly core-specific ECHO meetings
  • Ask the DAC and Ask the Lab Core sessions
  • Study Coordinator Collaboration calls
  • Prenatal POD meetings
• Facilitate and lead internal team meetings to review timelines, regulatory updates, and operational progress.

6. Travel:

• Occasional travel is required for annual in-person ECHO consortium meetings, national trainings, and other collaborative events.

Bachelor’s degree in relevant field, Master’s preferred

N/A

Minimum 3 years of relevant experience

• Knowledge of business and management principles.
• Ability to direct, manage, implement, and evaluate department operations.
• Ability to establish department goals and objectives that support the strategic plan.
• Ability to effectively plan, delegate and/or supervise the work of others.
• Ability to lead, motivate, develop, and train others.
• Ability to make decisions independently and communicate effectively with the PIs and research team.

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