Study Start-Up Lead: Accelerate Clinical Trial Activation

ECN Operating LLC; United States; Remote; USD 75,000 - 110,000; Full time

Job summary

ECN Operating LLC is seeking a Study Start-Up Specialist to drive end-to-end start-up activities across the Patient Advocacy & Engagement (PAE) department. You will ensure recruitment infrastructure, regulatory approvals, and cross-functional workflows are in place prior to site Greenlight.

This role acts as the central coordinator between Business Development, Regulatory, Contracts & Budgets, Finance, Operations, and Site Management, advancing timely activation and compliant patient engagement.

Qualifications

• Bachelor's degree in a relevant field and 3–5 years clinical research start-up experience.
• Proven ability to lead end-to-end study start-up workflows across multiple departments.
• Experience with IRB/sponsor approvals and regulatory tracking.

Responsibilities

• Initiate end-to-end study start-up activities upon award notification.
• Own and maintain the PAE start-up task management system with owners, due dates, escalation triggers.
• Monitor milestones across the start-up lifecycle including CTA, SIV, IRB approvals.
• Coordinate with Contracts & Budgets and serve as PAE liaison to avoid delays.
• Lead process improvements and mentor junior PAE coordinators.

Skills

Project & Process Management

Communication & Stakeholder Influence

Leadership & Mentorship

Attention to Detail & Compliance Mind-

Cross-Functional Collaboration

Data-Driven Decision Making

Urgency & Adaptability

Education

Bachelor's degree in Healthcare Administration, Life Sciences, Business, Communications, Marketing, or a related field

Equivalent combination of education and directly relevant experience

Minimum 3-5 years of experience in clinical research, patient recruitment, study start-up, or related healthcare/CRO

Tools

RealTime CTMS

Microsoft Office Suite

Microsoft Planner

IRB submission portals & regulatory tracking tools

Job description

ECN Operating LLC is seeking a Study Start-Up Specialist to drive end-to-end start-up activities across the Patient Advocacy & Engagement (PAE) department. You will ensure recruitment infrastructure, regulatory approvals, and cross-functional workflows are in place prior to site Greenlight.

This role acts as the central coordinator between Business Development, Regulatory, Contracts & Budgets, Finance, Operations, and Site Management, advancing timely activation and compliant patient engagement.