Clinical Trials Regulatory Coordinator

Tufts Medical Center; Boston (MA); On-site; USD 29,000 - 37,000; Full time

Job summary

Tufts Medical Center seeks a Regulatory Project Manager to support clinical research under PI supervision. You will coordinate protocol submissions, prepare regulatory documents, and maintain study records to ensure compliance with Tufts policies and FDA/ICH guidelines.

You will collaborate with faculty, NCCCR, and external partners to ensure timely regulatory reporting and maintain data privacy. You will liaise with regulatory agencies, sponsors, and study teams, manage documentation, and help

Qualifications

• Bachelor’s degree required.
• One year of research-related experience preferred.
• Coordinates protocol submissions and maintains regulatory records to ensure compliance.
• Maintains HIPAA confidentiality and adherence to data security.
• Familiar with FDA GCP guidelines and related regulatory requirements.

Responsibilities

• Assist with coordinating protocol startup and regulatory submissions.
• Prepare and submit regulatory documents for reviews.
• Maintain study records and ensure regulatory compliance with Tufts Medicine policies and federal guidelines.
• Collaborate with investigators, study coordinators, and external partners.
• Track submissions, amendments, safety reports, and regulatory communications.
• Communicate with study teams and regulatory offices to ensure timely information flow.
• Ensure regulatory reporting requirements are met and aligned with FDA GCP.

Skills

Organizational skills

Attention to detail

Data analysis

Communication skills

Time management

Education

Bachelor’s Degree

Tools

Microsoft Word

Job description

Tufts Medical Center seeks a Regulatory Project Manager to support clinical research under PI supervision. You will coordinate protocol submissions, prepare regulatory documents, and maintain study records to ensure compliance with Tufts policies and FDA/ICH guidelines.

You will collaborate with faculty, NCCCR, and external partners to ensure timely regulatory reporting and maintain data privacy. You will liaise with regulatory agencies, sponsors, and study teams, manage documentation, and help