Clinical Regulatory Coordinator for Research Submissions

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

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.