Lyme Disease Clinical Programs Lead

Tufts University; Boston (MA); On-site; USD 74,000 - 111,000; Full time

Job summary

Tufts University’s Department of Molecular Biology and Microbiology seeks a Clinical Research Program Manager to lead a multi‑site Lyme disease research program spanning three regional hubs and more than 20 sites across New England. This role reports to study leadership and provides study‑wide project management and regulatory leadership for the Tufts single IRB.

The ideal candidate brings strong clinical research operations experience, excellent organizational and communication skills, and the

Qualifications

• Advanced degree in clinical research, public health, project management, health administration, life sciences, nursing, or related field.
• 5+ years of progressively responsible clinical research experience, including multi-site studies.
• Strong IRB experience, including single‑IRB oversight and relying agreements.
• Demonstrated project-management experience: timeline development, milestone tracking, risk management, dependency tracking, and stakeholder communication.
• Experience supervising, training, or leading clinical research staff.
• Experience developing and maintaining MOPs, SOPs, training materials, study workflows, onboarding tools, or controlled documentation.
• Experience supporting study recruitment, enrollment tracking, participant retention, and follow‑up workflows.
• Ability to coordinate work across clinical operations, regulatory, data-management, laboratory, and investigator teams.
• Excellent written and verbal communication skills; strong organizational skills and ability to manage multiple priorities in a fast‑paced environment.
• Knowledge of Good Clinical Practice, human‑subjects protections, HIPAA, and applicable clinical research regulations.
• Ability to travel to clinical sites as needed.

Responsibilities

• Serve as the operational center of the Coordinating Center, driving study infrastructure and cross‑group coordination.
• Serve as primary regulatory lead for Tufts single IRB: prepare submissions, modifications, continuing reviews, and consent revisions.
• Maintain study timelines, milestones, and dependencies; manage risks, decisions, and action items; oversee protocol amendments and operational changes across hubs and sites.
• Create, maintain, and update study Manuals of Procedures, SOPs, workflows, and controlled documentation.
• Develop onboarding, refresher, and ongoing training for study coordinators and site staff across hubs.
• Track enrollment and retention across hubs and sites; identify barriers and develop participant‑facing materials.
• Coordinate with the Diagnostic Core and Data Center to keep deliverables on schedule and ensure data quality.
• Oversee Tufts hub operations and affiliated sites; train, onboard, supervise, and support Tufts study coordinators and delegated staff.

Skills

Project management

Communication

Organizational skills

Travel readiness

IRB experience

Education

Advanced degree in clinical research/related field

Tools

REDCap

R

SAS

Python

Job description

Tufts University’s Department of Molecular Biology and Microbiology seeks a Clinical Research Program Manager to lead a multi‑site Lyme disease research program spanning three regional hubs and more than 20 sites across New England. This role reports to study leadership and provides study‑wide project management and regulatory leadership for the Tufts single IRB.

The ideal candidate brings strong clinical research operations experience, excellent organizational and communication skills, and the