Regulatory Specialist, Study Start-Up

Barrington James; Oregon; On-site; USD 90,000 - 130,000; Full time

Job summary

Barrington James is seeking a regulatory start-up lead to own regulatory activities from study selection through site activation across multiple research sites. You will coordinate with business development and operations to keep study start-up on track and maintain inspection-ready files.

The role requires strategic, analytical thinking, excellent organization, and a track record of delivering high-quality work to deadlines, with clear communication to remote teams and cross-functional partners.

Qualifications

• Experience in regulatory or study start-up within a clinical research site network.
• Excellent organizational skills and attention to detail.
• Ability to meet deadlines with high-quality work.
• Strategic analytical thinking and data-informed decision making.
• Clear communication with remote, cross-functional teams.

Responsibilities

• Own regulatory submissions and documentation for new studies across multiple research sites.
• Coordinate with business development and operations to keep start-up on track.
• Maintain inspection-ready regulatory files.
• Identify risks and bottlenecks early and propose practical solutions.
• Help refine and improve start-up processes as the team scales.

Skills

Regulatory submissions

Study start-up

Cross-functional collaboration

Attention to detail

Independent working

Tools

eRegulatory systems

Job description

The role

You’ll own regulatory activities from study selection through site activation, working closely with business development, patient recruitment, site leadership and quality and compliance.

What you’ll do

• Manage regulatory submissions and documentation for new studies across multiple research sites
• Coordinate proactively with business development and operational teams to keep study start-up on track
• Maintain accurate, inspection-ready regulatory files
• Spot risks and bottlenecks early and propose practical solutions
• Help refine and improve start-up processes as the team scales

About you

• Prior regulatory or study start-up experience within a clinical research site network, ideally one of similar scale and pace
• Excellent organisation and exceptional attention to detail
• A strong sense of urgency and a track record of delivering high-quality work to deadlines
• Strategic, analytical thinking: you connect the dots and don’t just execute tasks
• Confident working independently and communicating clearly with remote, cross-functional teams