Clinical Research Regulatory Specialist

Tufts Medical Center; Boston (MA); On-site; USD 30,000 - 37,000; Full time

Job summary

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

Collaborating with NCCCR staff, coordinating with sponsors and external partners, you will track submissions, manage documents, and support startup activities while upholding HIPAA and data

Qualifications

• Bachelor’s Degree required.
• CITI Human Research Protection Certification preferred.
• IRB submission experience is desirable.

Responsibilities

• Assist with tracking and managing new protocols in start-up and monitor progress.
• Responsible for IRB requirements and submission of review documents.
• Maintain tracking for SRC/IRB submissions, amendments and safety reporting.
• Ensure patient confidentiality per HIPAA and secure data storage.
• Review protocols, prepare approval submissions, and implement improvements as needed.
• Collaborate with coordinators, regulatory project manager, and investigators on submissions.
• Communicate with study team, sponsors, and regulatory offices to relay information.
• Ensure regulatory reporting requirements are met.
• Adhere to FDA Good Clinical Practice guidelines.

Job description

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

Collaborating with NCCCR staff, coordinating with sponsors and external partners, you will track submissions, manage documents, and support startup activities while upholding HIPAA and data