Clinical Trials Regulatory Coordinator

Tufts Medicine; Boston (MA); Hybrid; USD 45,000 - 56,000; Full time

Job summary

Tufts Medicine seeks a Regulatory Project Manager to complete regulatory requirements for clinical research projects under the direction of investigators and a Clinical Research Regulatory PM.

You will coordinate protocol submissions, prepare regulatory documents, and maintain records to ensure compliance with Tufts Medical Center policies, federal regulations, and ICH/GCP guidelines. Collaborates with NCCCR and external partners to manage amendments and reporting.

Qualifications

• Bachelor’s Degree required.
• One year of research-related experience preferred.
• CITI Human Research Protection Certification preferred.
• Previous regulatory/IRB submission experience is desired.

Responsibilities

• Assist with tracking and managing new protocols in start-up; initiates, facilitates, and monitors study start-up progress to ensure benchmarks are met.
• Responsible for IRB requirements for each study including education compliance and submitting documents for review.
• Create and maintain tracking for SRC/IRB submissions, amendments, safety reporting, and deviation or event reporting.
• Maintain patient confidentiality per HIPAA and secure study information.
• Review existing protocols, prepare approvals, file regulatory documents, and follow applicable regulations.
• Collaborate with research coordinators, regulatory project manager, investigators, and departments for submissions.
• Establish and maintain regular communication with study team, sponsor, and regulatory agencies to ensure timely information flow.
• Ensure regulatory reporting requirements are met and adhere to FDA GCP guidelines.

Skills

Organizational skills

Data analysis

Attention to detail

Computer skills

Communication skills

Regulatory knowledge

Education

Bachelor's Degree

Job description

Tufts Medicine seeks a Regulatory Project Manager to complete regulatory requirements for clinical research projects under the direction of investigators and a Clinical Research Regulatory PM.

You will coordinate protocol submissions, prepare regulatory documents, and maintain records to ensure compliance with Tufts Medical Center policies, federal regulations, and ICH/GCP guidelines. Collaborates with NCCCR and external partners to manage amendments and reporting.