Clinical Trials Regulatory Coordinator

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

Job summary

Tufts Medicine is seeking a Regulatory/IRB Coordinator to support the coordination of regulatory submissions and ensure compliance with Tufts Medical Center policies, FDA regulations and ICH/GCP guidelines. You will work with faculty, investigators and cross-functional teams in NCCCR under the direction of principal investigators and regulatory managers.

The role involves tracking, document management, and timely reporting of protocol amendments, safety events, and deviations, with an emphasis

Qualifications

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

Responsibilities

• Assist with coordinating startup of new protocols and monitor start-up progress.
• Handle IRB requirements for each study and submit required documents.
• Create and maintain tracking for protocol amendments, consent forms, safety reporting and deviations.
• Maintain patient confidentiality and secure study records.
• Review protocols, prepare approval submissions, file regulatory documents and follow regulations.
• Collaborate with study team, regulatory project manager and investigators on submissions.
• Maintain regular communication with study team, sponsor and regulatory offices for timely information.
• Ensure regulatory reporting requirements are met.
• Adhere to FDA Good Clinical Practice guidelines.

Skills

Organizational skills

Data analysis

Attention to detail

Word processing

Prioritization

Communication

Regulatory knowledge

Education

Bachelor's Degree

Job description

Tufts Medicine is seeking a Regulatory/IRB Coordinator to support the coordination of regulatory submissions and ensure compliance with Tufts Medical Center policies, FDA regulations and ICH/GCP guidelines. You will work with faculty, investigators and cross-functional teams in NCCCR under the direction of principal investigators and regulatory managers.

The role involves tracking, document management, and timely reporting of protocol amendments, safety events, and deviations, with an emphasis