Regulatory Coordinator (Clinical Research)

Location: Tufts Medical Center, United States; primarily onsite and sedentary

Pay range: $21.53–$26.91

Company

hirify.global provides medical and clinical research services, including cancer clinical research through the Neely Center for Cancer Clinical Research.

What you will do

• Coordinate clinical research regulatory requirements under the direction of principal investigators, the research director, and the regulatory project manager.
• Track study start-up activities, monitor progress against benchmarks, and maintain protocol and submission records.
• Prepare and submit IRB, SRC, protocol amendment, consent amendment, safety, deviation, and violation documentation.
• Maintain systematic communication and documentation with study teams, sponsors, regulatory agencies, cooperative groups, and external research organizations.
• Maintain patient confidentiality and secure study information in accordance with HIPAA requirements.
• Ensure regulatory reporting and study activities follow institutional policies, federal regulations, and FDA Good Clinical Practice guidelines.

Requirements

• Bachelor’s degree required.
• Strong organizational, data collection, and data analysis skills.
• Meticulous attention to detail and ability to prioritize quickly and appropriately.
• Excellent computer, written communication, and interpersonal skills.
• Working knowledge of current regulations, regulatory guidance, and local research policies.
• Ability to work at Tufts Medical Center and perform primarily sedentary, in-person duties.

Nice to have

• At least one year of research-related experience.

Culture & Benefits

• Collaborative work with faculty, clinical research teams, pharmaceutical industry representatives, federal agencies, and external research organizations.
• Comprehensive Total Rewards package supporting health, financial security, and career growth.
• Compensation considers relevant experience, certifications, education, skills, and internal equity.