Clinical Trials Regulatory Coordinator

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

Job summary

Tufts Medicine seeks a Regulatory Project Support role to assist with coordinating clinical research regulatory tasks under the direction of senior investigators. You will manage protocol submissions, maintain regulatory records, and collaborate with multidisciplinary teams to ensure compliance with Tufts Medical Center policies and ICH/GCP guidelines.

The role involves liaising with NCCCR and external partners, maintaining documentation, and ensuring timely reporting while upholding patient

Qualifications

• Bachelor’s Degree required.
• One year of research related experience preferred.

Responsibilities

• Assist with coordinating protocol start-up and monitor start-up progress to meet benchmarks.
• Handle IRB requirements for each study including training and submission of documents.
• Create and maintain tracking for SRC/IRB submissions, amendments, safety reporting, deviations or events.
• Maintain patient confidentiality per HIPAA and keep study information secure.
• Review protocols, prepare submissions, file regulatory documents, and implement improvements.
• Collaborate with study coordinators, regulatory project manager, principal investigators, and other departments on regulatory submissions.
• Maintain regular communication with study team, sponsor, and regulatory agencies to ensure timely information flow.
• Ensure compliance with FDA GCP guidelines.

Skills

Data collection & analysis

Attention to detail

Word processing

Prioritization

Communication skills

Regulatory knowledge

Education

Bachelor's Degree

Job description

Tufts Medicine seeks a Regulatory Project Support role to assist with coordinating clinical research regulatory tasks under the direction of senior investigators. You will manage protocol submissions, maintain regulatory records, and collaborate with multidisciplinary teams to ensure compliance with Tufts Medical Center policies and ICH/GCP guidelines.

The role involves liaising with NCCCR and external partners, maintaining documentation, and ensuring timely reporting while upholding patient