Regulatory Coordinator

Tufts Medical Center, Inc.; United States; On-site; USD 45,000 - 56,000; Full time

Job summary

Tufts Medical Center, Inc. is seeking a Regulatory Project Coordinator to complete regulatory requirements for clinical studies under PI and Clinical Research leadership. You will assist with protocol submissions, document maintenance, and regulatory compliance across collaborating teams.

The role involves coordinating with NCCCR and external entities, ensuring tracking accuracy, and adhering to HIPAA and GCP guidelines to support study integrity and regulatory success.

Qualifications

• Bachelor’s Degree required.
• One year of research-related experience preferred.

Responsibilities

• Track and manage new protocols in start-up and monitor progress.
• Handle IRB requirements and submission documents.
• Track SRC/IRB submissions, amendments, safety reporting, deviations or other events.
• Maintain patient confidentiality under HIPAA and secure study records.
• Review protocols for approval submissions and implement improvements with regulatory alignment.
• Collaborate with coordinators, regulatory team, PIs and departments for submissions.
• Maintain regular communication with study teams, sponsors and regulators for required information.
• Ensure regulatory reporting requirements are met.
• Adhere to FDA GCP guidelines.

Skills

Organizational skills

Attention to detail

Computer skills

Prioritization

Communication skills

Regulatory knowledge

Education

Bachelor’s Degree

Job description

Job Profile Summary

This role focuses on managing operational aspects of ongoing projects from initiation through completion and serves as liaison between project management and planning, project team, and line management. In addition, this role focuses on performing the following Administration Project Management duties: Serves as a liaison between the general project management office and the team members engaging in planning, reviews the status of projects and budgets, manages schedules, prepares status reports, and assesses project issues and develops resolutions to meet productivity, quality, and client-satisfaction. A professional individual contributor role that may direct the work of other lower level professionals or manage processes and programs. The majority of time is spent overseeing the design, implementation or delivery of processes, programs and policies using specialized knowledge and skills typically acquired through advanced education. An entry level role that applies broad theoretical job knowledge typically obtained through advanced education. May require the following proficiency: work is closely supervised, problems faced are not typically difficult or complex, and explains facts, policies and practices related to job area.

Job Overview

This position works under the direction of the Principal Investigator(s), Research Director, and Clinical Research Regulatory Project Manager to complete the regulatory requirements of the clinical research project. Assists with coordinating aspects of protocol submissions, prepares and submits regulatory documents, and maintains records on assigned studies to ensure regulatory compliance with Tufts Medical Center policies as well as federal regulation and ICH/GCP guidelines. Works collaboratively with a variety of personnel at all levels, including faculty and study team members of the Neely Center for Cancer Clinical Research (NCCCR) and external institutions, cooperative groups, clinical trials experts, representatives from the pharmaceutical industry, federal agencies, and other research organizations.

Job Description

Minimum Qualifications

• 1. Bachelor’s Degree.

Preferred Qualifications

• 1. One (1) year of research related experience.

Duties and Responsibilities

• 1. Assists with tracking and managing new protocols in start-up; initiates, facilitates, and monitors study start-up progress to ensure established benchmarks are met.
• 2. Responsible for Institutional Review Board (IRB) requirements for each study including meeting institutional educational requirements and submitting documents for review.
• 3. Creates and maintains tracking for all subsequent SRC/IRB submissions, protocol and consent amendments, safety reporting, deviation, violation or other event reporting.
• 4. Maintains patient confidentiality per HIPAA regulations and keeps study information in a safe and secure location.
• 5. Reviews existing protocols, taking time to prepare approval submissions, filing regulatory documents, implement improvements as needed, and follow regulations regarding research, assessment, and data gathering accurately.
• 6. Collaborates with research coordinators, regulatory project manager, principal investigators, and other departments with the submission of protocol amendments and other regulatory submissions.
• 7. Establishes and maintains regular communication with study team, study sponsor, applicable regulatory agencies/offices to ensure all required information is relayed and responsible for the systematic documentation/tracking when applicable.
• 8. Ensures various regulatory reporting requirements are met.
• 9. Adheres to FDA Good Clinical Practice (GCP) guidelines.

Physical Requirements

• 1. This is largely a sedentary role, which involves sitting most of the time, but may involve movements such as walking, standing, reaching, ascending/descending stairs, and operating office equipment.
• 2. Frequently required to speak, hear, communicate, and exchange information.
• 3. Ability to see and read computer displays, read fine print, and/or normal type size print and distinguish letters, numbers and symbols.
• 4. Requires manual dexterity using fine hand manipulation to operate computer keyboard.

Skills & Abilities

• 1. High degree of organizational talents data collection and analysis skills.
• 2. Requires meticulous attention to detail.
• 3. Excellent computer skills including word processing.
• 4. Ability to prioritize quickly and appropriately.
• 5. Excellent communication and interpersonal skills.
• 6. Maintains working knowledge of current regulations, regulatory guidance and or local policies.

At Tufts Medicine, we want every individual to feel valued for the skills and experience they bring. Our compensation philosophy is designed to offer fair, competitive pay that attracts, retains, and motivates highly talented individuals, while rewarding the important work you do every day. The base pay ranges reflect the minimum qualifications for the role. Individual offers are determined using a comprehensive approach that considers relevant experience, certifications, education, skills, and internal equity to ensure compensation is fair, consistent, and aligned with our business goals. Beyond base pay, Tufts Medicine provides a comprehensive Total Rewards package that supports your health, financial security, and career growth—one of the many ways we invest in you so you can thrive both at work and outside of it.

Pay Range: $21.53 - $26.91

Tufts Medicine is a leading integrated health system bringing together the best of academic and community health care to deliver exceptional, connected and accessible care experiences to consumers across Massachusetts. Comprised of Tufts Medical Center, Lowell General Hospital, MelroseWakefield Healthcare, an expansive home care network and a large clinically integrated physician network, Tufts Medicine has more than 15,000 dedicated employees and caregivers. The health system came together in 2014 to leverage the experience of its member organizations and integrate their missions to together transform the ways that consumers engage with and experience their care.