Regulatory Affairs Analyst: Clinical Trials in Oncology

Yale University; New Haven (CT); On-site; USD 55,000 - 85,000; Full time

Job summary

Yale University in New Haven is seeking a Regulatory Affairs Analyst to support regulatory activities for the Gynecologic Oncology CTO portfolio, including protocol submissions, continuing reviews, and training records.

You will partner with investigators, staff, sponsors, and auditors to ensure compliance, maintain regulatory files, and communicate regulatory matters clearly across teams.

Qualifications

• Experience with IRB protocols and submissions.
• Professional verbal and written communication skills.
• Proficient in Microsoft Office; willing to learn new platforms.

Responsibilities

• Collaborate with investigators and study teams to consult and identify trial objectives.
• Interpret research needs and translate them into application and operational requirements.
• Critically evaluate information from protocols, budgets and agreements to reconcile conflicts.
• Analyze data and develop reporting modules, ad-hoc analyses and related tools.
• Develop and maintain documentation and libraries on key processes.
• Assess risk and ensure compliance with protocols, university procedures and third-party regulations.
• Determine training needs and conduct training sessions with study teams.

Skills

IRB submissions

Verbal & written communication

Microsoft Office

Independent work

Time management

Multi-project handling

Education

Bachelor’s degree in related field

Job description

Yale University in New Haven is seeking a Regulatory Affairs Analyst to support regulatory activities for the Gynecologic Oncology CTO portfolio, including protocol submissions, continuing reviews, and training records.

You will partner with investigators, staff, sponsors, and auditors to ensure compliance, maintain regulatory files, and communicate regulatory matters clearly across teams.