Remote-Ready Study Start-Up Lead

Elite Clinical Network; United States; On-site; USD 90,000 - 130,000; Full time

Job summary

Elite Clinical Network is seeking a Study Start-Up Specialist to lead end-to-end study start-up activities across the Patient Advocacy & Engagement (PAE) department, ensuring recruitment infrastructure, regulatory approvals, and cross-functional workflows are in place for activation prior to site Greenlight.

You will coordinate with Business Development, Regulatory, Contracts & Budgets, Finance, Operations, and Site Management teams to accelerate activation, improve recruitment performance, and

Qualifications

• Bachelor's degree in Healthcare Administration, Life Sciences, Business, Communications, Marketing, or a related field
• Equivalent combination of education and directly relevant experience will be considered
• Minimum 3–5 years of experience in clinical research, patient recruitment, study start-up, or a related healthcare/CRO environment
• Demonstrated experience managing end-to-end clinical trial start-up workflows, including cross-functional coordination across regulatory, contracts, finance, and operations teams
• Demonstrated ability to lead process improvement initiatives and contribute to strategic planning within a fast-paced clinical operations environment
• Proven experience tracking and managing essential study documents and regulatory approval processes (IRB, sponsor approvals)

Responsibilities

• Initiate end-to-end study start-up activities upon receipt of study award notification at pre-award, including supporting PAE Director on recruitment strategy.
• Own and maintain the PAE study start-up task management system, ensuring all workflow stages are tracked from Pre-Award through Greenlight Activation, with assigned owners, due dates, and escalation triggers.
• Monitor and track all process milestones across the study start-up lifecycle, including CTA execution status, SIV/Greenlight dates, IRB approval status, sponsor approvals, and essential document collection proactively escalating delays to the PAE Director.
• Coordinate with the Contracts & Budgets (C&B) team on new study awards, contract execution timelines, and CTA signing status; serve as the PAE liaison to ensure recruitment preparation is not delayed pending contract finalization.
• Serve as a subject-matter expert and informal mentor for junior PAE start-up and recruitment coordinators, providing guidance on workflow best practices and troubleshooting complex study start-up issues.
• Identify recurring bottlenecks in the study start-up lifecycle and lead process improvement initiatives, including updates to SOPs, workflow templates, and the task management system.
• Partner with the PAE Director on department-wide start-up strategy, contributing recommendations informed by cross-study trends and performance data.
• Represent PAE study start-up operations in cross-departmental leadership discussions and provide status updates to senior stakeholders as needed.

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 related field

Equivalent combination of education and directly relevant experience will be considered

Tools

RealTime CTMS

Microsoft Office Suite

Microsoft Planner/Teams

IRB submission portals

Job description

Elite Clinical Network is seeking a Study Start-Up Specialist to lead end-to-end study start-up activities across the Patient Advocacy & Engagement (PAE) department, ensuring recruitment infrastructure, regulatory approvals, and cross-functional workflows are in place for activation prior to site Greenlight.

You will coordinate with Business Development, Regulatory, Contracts & Budgets, Finance, Operations, and Site Management teams to accelerate activation, improve recruitment performance, and