Regulatory Trials Analyst – Oncology Research

Yale Cancer Center; New Haven, Northern (CT, KY); Hybrid; USD 55,000 - 85,000; Full time

Job summary

Yale Cancer Center in New Haven is seeking a Clinical Research Analyst to support regulatory affairs for the Gynecologic Oncology CTO. You will assist with protocol submissions, IRB continuations, training tracking, and file management across sponsor monitors and inspectors.

The role requires a bachelor’s degree and one year of related experience, strong communication, and ability to work with cross-functional teams in a fast-paced environment on-site.

Qualifications

• Experience with IRB protocols and submissions; strong written and verbal communication.
• Proficient in Microsoft Office; able to pick up new software quickly.
• Ability to work independently, manage priorities, and meet deadlines.
• Attention to detail in a fast-paced, collaborative environment.

Responsibilities

• Assist with set-up, activation, and ongoing support of trial types.
• Prepare and submit initial protocol, amendments, and continuing reviews to committees.
• Track training, regulatory documents, and safety reports across staff and sites.
• Maintain regulatory files and liaise with CTO staff, sponsors, monitors, and inspectors.
• Communicate regulatory risks and business opportunities to study teams.

Skills

IRB protocols/submissions

Regulatory submissions

Microsoft Office

Cross-functional communication

Time management

Education

Bachelor's degree

Job description

Yale Cancer Center in New Haven is seeking a Clinical Research Analyst to support regulatory affairs for the Gynecologic Oncology CTO. You will assist with protocol submissions, IRB continuations, training tracking, and file management across sponsor monitors and inspectors.

The role requires a bachelor’s degree and one year of related experience, strong communication, and ability to work with cross-functional teams in a fast-paced environment on-site.