Project Coordinator - Emergency Medicine

• Job Type: Officer of Administration
• Regular/Temporary: Regular
• Hours Per Week: 35
• Salary Range: $70,000.00 - $77,000.00

Position Summary

The Project Coordinator provides centralized operational leadership for the STIckER R01, a 5-year multi-site stepped-wedge cluster randomized effectiveness-implementation trial across 13 emergency departments at four academic medical centers. The Project Coordinator is responsible for translating the awarded protocol into day-to-day execution, ensuring regulatory and NIH compliance, supporting timely milestone delivery, coordinating across sub awardees and vendors, and serving as the primary operational point of contact for the PIs, study team, and the Data and Safety Monitoring Board.

Responsibilities

 Project Administration, Governance, and Communication

• Maintain the master project workplan, milestone tracker, STIckER R01 Tracker, project contacts list, shared calendars, meeting schedules, and project SharePoint.
• Maintain version control of the protocol, manuals of procedures, training materials, SOPs, regulatory documents, meeting materials, and other key study files.
• Schedule, agenda, staff, and document MPI check-ins and full-team meetings, including action items, decision logs, and follow-through.
• Maintain communication norms across the study team, including HIPAA-compliant communication channels, project email distribution lists, shared calendars, and shared file systems.
• Support coordination across MPIs, Co-Is, site PIs, site coordinators, trainees, vendors, consultants, sponsored projects teams, and other collaborators

Regulatory, IRB, NIH Reporting, and Compliance

• Serve as the central regulatory coordinator for WCG IRB across all 13 emergency departments, including annual continuing review, amendments, protocol modifications, deviations, reportable events, and reliance agreements.
• Support local site IRB documentation and institution-specific human subjects requirements in coordination with site coordinators and subaward teams.
• Maintain the master regulatory binder, including approved protocol versions, consent waivers, recruitment materials, survey instruments, SMS templates, and other participant-facing materials.
• Coordinate NIH reporting and compliance activities, including annual and final RPPRs, subaward inputs, Just-in-Time or similar updates, Other Support and biosketch files, and sponsor-facing documentation.
• Maintain ClinicalTrials.gov compliance, including registration before first enrollment, annual updates, and results reporting.
• Coordinate Public Access compliance for resulting publications, including NIHMS submissions, PubMed Central tracking, funding acknowledgement language, and PMCID tracking.
• Track and report unanticipated problems, protocol deviations, and safety events according to IRB and DSMB requirements.

Multi-Site Trial Operations, Enrollment, and Implementation

• Serve as the day-to-day operational contact for site research coordinators at Weill Cornell, University of Chicago, and Yale.
• Maintain site and step-level tracking systems for enrollment, regulatory status, training completion, deviations, Go-Live readiness, and post-launch performance.
• Develop and maintain site implementation plans and readiness checklists for each emergency department.
• Coordinate pre-launch preparation, Go-Live activities, and site-specific operational needs across the stepped-wedge schedule.
• Perform virtual consents with participants for the qualitative interviews and linkage research arms along with coordination of linkage appointments
• Monitor enrollment against site and step-specific targets, produce reports for the MPIs and site PIs, identify underperforming sites, and propose corrective actions.
• Oversee Aim 3 follow-up operations, including 1-month and 4-month surveys, SMS configuration and reporting, opt-out tracking, linkage to outpatient sexual health services, participant compensation documentation, losses to follow-up, and protocol deviations.
• Coordinate the qualitative arm, including participant scheduling, transcription, coding support, tracking against the analytic plan, and maintenance of IRB-approved qualitative materials.
• Coordinate site visits and qualitative field visits in collaboration with the implementation science team.

Vendor, Technology, Data Quality, DSMB, and Finance Coordination

• Serve as the operational lead for the Modus relationship during the Year 1 app refinement period and across subsequent releases.
• Partner with departmental research administrative team to track vendor deliverables, release timelines, invoicing, BAAs, information security documentation, scope changes, technical delays, and technology-related issues requiring PI decision.
• Manage SMS platform needs in coordination with Aim 3 follow-up operations, including message scheduling, opt-out handling, and reporting.
• Support data quality monitoring in collaboration with the biostatistical team and site coordinators, including tracking missing data, data completeness, and data quality concerns.
• Stand up and maintain the DSMB, including the DSMB charter, member appointments, conflict-of-interest review, meeting logistics, DSMB packets, recommendations, and follow-through.
• Prepare and distribute DSMB packets for Year 1 protocol review, Year 3 interim review, and Year 5 closeout, including enrollment, safety, data quality, and implementation outcomes as appropriate.
• Partner with the departmental research administration team to monitor study related post award activities, including subaward progress and invoicing.
• Oversee participant compensation and reconciliation.

Dissemination, Publications, and Knowledge Products

• Maintain the project publications, presentations, authorship, conference submission, and trainee output tracker.
• Coordinate manuscript and abstract timelines in collaboration with the MPIs, Co-Is, trainees, and site collaborators.
• Coordinate manuscript timelines for the four primary manuscripts planned for Year 5, including effectiveness outcomes, implementation outcomes, and linkage outcomes.
• Coordinate scientific meeting submissions, including PAS, SAEM, ACEP Research Forum, IDWeek, and CROI as applicable.
• Support planning for the project website and public repository deliverables in Year 5, including the de-identified public-use dataset.

Minimum Qualifications

• Bachelor's degree or equivalent in education and experience required, plus 3 years related experience.

Preferred Qualifications

• Bachelor’s degree with clinical research project management experience, or Master’s degree, such as MPH, MS, or MHA, with comparable experience.
• Experience managing clinical research projects, ideally including federally funded or NIH-funded multi-site research, subaward coordination, and cross-institutional study operations.
• Working knowledge of NIH grant administration, single IRB models, human subjects protections, HIPAA, Good Clinical Practice, ClinicalTrials.gov, RPPRs, Just-in-Time submissions, Other Support, and Public Access compliance.
• Experience with electronic data capture systems, such as REDCap or equivalent, and basic data quality monitoring.
• Excellent written and verbal communication skills, including the ability to draft sponsor-facing, IRB-facing, and study-team-facing documents.
• Strong organizational skills, attention to detail, and ability to manage parallel workstreams across multiple institutions.
• Relevant content or methods experience may include stepped-wedge or cluster-randomized trial operations, implementation science frameworks such as EPIS, CFIR, or RE-AIM, digital health vendors, SMS-based participant follow-up platforms, adolescent and young adult sexual health research, or emergency department research operations.

Other Requirements

• Successful completion of all required compliance and systems training.

Equal Opportunity Employer / Disability / Veteran

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