"Clinical Research Coordinator"

Job Summary

This position will play a central role in establishing HSDM’s clinical research infrastructure from the ground up, including developing operational workflows, scheduling systems, and processes for sample collection, storage, and coordination with study teams. The coordinator will work closely with the Director of Research and Training Programs to build and standardize school-wide procedures for clinical research compliance, conduct, and data management. Responsibilities include working with the PIs in the overall project planning, coordination and timelines, working with the grant office to manage budgets and timelines, ensuring regulatory compliance, assisting with IRB reporting, handling updates to the project website, and setting the agenda for investigator meetings. Additionally, this person will support the investigative team in creating online surveys, collaborating with the project statistician on data management, assist in staff training, and oversee activities at the study sites.

Job-Specific Responsibilities

• Develops, implements, and maintains standardized study workflows and clinical research processes at HSDM, including participant scheduling, sample collection logistics, data capture workflows, and coordination with PIs and clinical operations.
• Ensures site compliance with research protocols by reviewing all regulatory requirements to confirm implementation of appropriate methods, practices, and procedures for all research activities
• Prepares and submits documents to Institutional Review Boards (IRBs).
• Participates in preparation and management of research budgets.
• Prepare clinical space for scheduled visits
• Manages daily operations to ensure clinical trials proceed efficiently and achieve their milestones for study completion
• Works in partnership with researchers to handle tasks related to recruiting, screening, enrolling, and following up with study participants.
• Oversees data management for research projects.
• Supports data entry tasks by accurately inputting information into relevant databases. Ensure the recorded and managed data from participants' visits is properly maintained.
• Conveys and coordinates detailed study needs with the research team, encompassing internal members, external partners, sponsors, monitors, Principal Investigators (PIs), and participants.
• Supports Principal Investigators in conducting study procedures, managing data, and performing analysis as needed.
• Ensures that all testing materials, equipment and supplies needed for the study are in-stock and in good working order.
• Monitors study materials to ensure compliance with protocols and regulatory standards.
• Assists staff, faculty, and collaborators in producing essential data, figures, or summary information.
• Engages in drafting research proposals, compiling reports, creating presentations, and contributing to publications.
• Maintains excellent responsiveness and communication with the PIs, ensuring tasks are completed promptly and on schedule.
• Offers administrative support to research staff, including photocopying, scheduling meetings and rooms, ordering and shipping supplies, among other tasks.
• Demonstrates a commitment to diversity, inclusion, and cultural awareness through actions, interactions, and communications with others.
• Contributes to the mission and vision of HSDM and models the School’s core values in all facets of the work.
• Performs other related duties as assigned or requested.

Working Conditions

• Work may be performed in a clinical setting.
• Prolonged periods of sitting at a desk and working on a computer.
• Walking and navigating around clinical and laboratory spaces.
• Must be able to lift to 20 pounds at times.

Basic Qualifications

• 3+ years of related experience in clinical research; a combination of education and experience may be considered.
• Knowledge of regulations/guidance governing clinical research.
• Proficiency in Microsoft Office applications and internet applications.
• Ability to work onsite, full-time.
• Ability to successfully pass a comprehensive background check at hire.

Additional Preferred Qualifications

• Bachelor’s degree in related field.
• Experience working with Institutional Review Boards for human clinical studies including protocol generation, continuing review, enrollment tracking, and completion of required forms (consent, adverse event, etc.).
• Experience with data entry.
• Experience with participant recruitment.
• Experience with clinical studies involving medical devices, biologics, or drugs is preferred.
• Excellent organizational skills, attention to detail, creativity, and effective communication (oral and written) abilities.
• Ability to work on and track multiple projects and meet deadlines.
• Ability to handle confidential information with discretion.
• Willingness to work at all levels to accomplish team goals.
• Ability to work with study participants, caregivers, and staff in a clinical/research setting. IACUC and COMS (institutional biosafety committee) experience are also preferred but not required.

Additional Information

• Standard Hours/Schedule: 35 hours per week
• Visa Sponsorship Information: Harvard University is unable to provide visa sponsorship for this position
• Pre-Employment Screening: Identity, Education, Criminal, Credit, Certification/License, Motor Vehicle Record, Drug Test, DOT Physical, CORI, Employment, Prohibited Parties, Not Applicable

Work Format Details
This position has been determined by school or unit leaders that all duties and responsibilities must be performed at a Harvard or Harvard-designated location. Certain visa types may limit work location. Individuals must meet work location sponsorship requirements prior to employment.

Salary Grade and Ranges
This position is salary grade level 055. Please visit Harvard's Salary Ranges to view the corresponding salary range and related information.