Regulatory Coordinator - Clinical Research Submissions Lead

Tufts Medical Center, Inc.; United States; On-site; USD 30,000 - 37,000; Full time

Job summary

Tufts Medical Center, Inc. seeks a Regulatory Project Coordinator to manage regulatory aspects of clinical research projects under investigators and directors. You will coordinate protocol submissions, prepare regulatory documents, and maintain records to ensure compliance with Tufts policies and FDA/ICH guidelines.

Collaboration spans faculty, study teams, external institutions, and sponsors. The role emphasizes meticulous documentation, communication, and adherence to GCP, with opportunities

Qualifications

• Bachelor’s degree required.
• One year of research experience preferred.
• CITI Human Research Protection Certification preferred.
• Experience with regulatory/IRB submissions preferred.

Responsibilities

• Assist with tracking and coordinating new protocols in startup; monitor progress to meet benchmarks.
• Ensure IRB requirements are met and submit documents for review.
• Create and maintain tracking for SRC/IRB submissions and amendments.
• Maintain patient confidentiality per HIPAA and safeguard study information.
• Prepare and file regulatory submissions; implement improvements as needed.
• Collaborate with coordinators, regulatory project manager, and investigators on submissions.

Skills

Organizational skills

Analytical skills

Communication

Computer skills

Attention to detail

Education

Bachelor’s Degree

Job description

Tufts Medical Center, Inc. seeks a Regulatory Project Coordinator to manage regulatory aspects of clinical research projects under investigators and directors. You will coordinate protocol submissions, prepare regulatory documents, and maintain records to ensure compliance with Tufts policies and FDA/ICH guidelines.

Collaboration spans faculty, study teams, external institutions, and sponsors. The role emphasizes meticulous documentation, communication, and adherence to GCP, with opportunities