Clinical Research Manager

The Department of Molecular Biology and Microbiology at Tufts University School of Medicine works to improve global health by using molecular genetics and innovation to address fundamental and medically related problems in microbiology. Training is a core tenet of the department's approach, with students, postdocs, and staff serving as key drivers of its scientific impact. Founded on community building, mentorship, and collaboration, the department is committed to fostering a diverse, inclusive scientific community that welcomes a range of perspectives to produce more innovative and impactful science.

The Clinical Research Program Manager is the operational lead of the Coordinating Center for a multi-site Lyme disease research program spanning three regional hubs and more than 20 clinical and data-collection sites across New England. Reporting to study leadership, this role provides study-wide project management and serves as the primary regulatory lead for the Tufts single IRB, coordinating across clinical operations, data management, laboratory operations, investigative project teams, documentation, training, and stakeholder communications. The ideal candidate brings strong clinical research operations experience, excellent organizational and communication skills, and the ability to manage complex timelines, cross-functional workflows, and competing priorities across multiple institutions.

Basic Requirements:
Knowledge and experience typically acquired by:

• Advanced degree in clinical research, public health, project management, health administration, life sciences, nursing, or a related field, or equivalent experience.
• At least 5 years of progressively responsible clinical research experience, including managing complex, multi-site or multi-institutional studies.
• Strong IRB experience, including single-IRB oversight and negotiating or managing reliance 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, including developing participant-facing retention materials.
• 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, highly collaborative environment.
• Knowledge of Good Clinical Practice, human-subjects protections, HIPAA, and applicable clinical research regulations.
• Ability to travel to clinical sites as needed.

Preferred Qualifications:

• Experience managing NIH-funded clinical or translational research.
• Familiarity with REDCap sufficient to understand data-team workflows and communicate effectively about data collection, reports, and database changes.
• Ability to independently access and analyze study data using R, SAS, Python, or similar tools to build enrollment, retention, and operational reports that inform decisions.
• Experience coordinating biospecimen collection, laboratory workflows, or biorepository procedures.
• Formal project-management training or certification.
• Familiarity with infectious-disease, longitudinal studies, or biorepository research