Study Start-Up Specialist
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Job Description
Study Start-Up Specialist coordinating clinical trial approvals, budgets, documents, and recruitment readiness. Enabling faster activation for ECN Operating LLC’s patient advocacy and engagement operations.
Responsibilities:
- Initiate end-to-end study start-up activities upon receipt of study award notification at pre-award, including supporting the PAE Director on recruitment strategy
- Own and maintain the PAE study start-up task management system from Pre-Award through Greenlight Activation
- Track workflow stages, assigned owners, due dates, escalation triggers, and process milestones
- Monitor CTA execution, SIV/Greenlight dates, IRB approvals, sponsor approvals, and essential document collection
- Proactively escalate delays to the PAE Director
- Coordinate with Contracts & Budgets on study awards, contract execution timelines, and CTA signing status
- Serve as the PAE liaison to ensure recruitment preparation is not delayed by contract finalization
- Mentor junior PAE start-up and recruitment coordinators
- Identify study start-up bottlenecks and lead process improvement initiatives, including SOP, workflow template, and task management system updates
- Partner with the PAE Director on department-wide start-up strategy
- Represent PAE study start-up operations in cross-departmental leadership discussions and provide senior stakeholder updates
- Track, collect, and manage essential study start-up documents, including protocols, ICFs, sponsor-required materials, and site-specific documentation
- Ensure IRB and sponsor approvals are obtained before deploying patient-facing recruitment materials
- Coordinate with Regulatory on IRB submission and approval timelines and ensure recruitment materials use IRB-approved language
- Submit recruitment budget requests to Finance and track approved spend
- Submit budget amendment requests as needed
- Support vendor payment processes and maintain Google and Meta advertising vendors on an invoicing model
- Conduct mandatory 30-day recruitment performance reviews for active studies
- Synthesize portfolio-wide recruitment start-up performance trends and present recommendations to the PAE Director
- Coordinate with Business Development, Operations, Regulatory, Contracts & Budgets, Finance, and Site Management
- Communicate confirmed Greenlight and SIV dates to the PAE team to coordinate patient matching, outreach scheduling, and mass text deployment
Requirements:
- 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
- Experience managing end-to-end clinical trial start-up workflows
- Cross-functional coordination across regulatory, contracts, finance, and operations teams
- Ability to lead process improvement initiatives and contribute to strategic planning
- Experience tracking and managing essential study documents and regulatory approval processes, including IRB and sponsor approvals
- Experience working with or alongside Contracts & Budgets teams on clinical trial agreement execution and study award processes
- Proficiency in RealTime CTMS or comparable clinical trial management system
- Proficiency in Microsoft Office Suite: Word, Excel, PowerPoint, and Outlook
- Experience with Microsoft Planner, Teams, or equivalent project management tools
- Experience with IRB submission portals and regulatory tracking tools/processes
- Ability to manage multiple concurrent studies with competing deadlines in a fast-paced environment
- Strong attention to detail and commitment to document accuracy and process compliance
- Ability to work cross-functionally with multiple departments and external vendors
- Availability to respond promptly when study award notifications are received, including at the start of compressed CTA/SIV timelines
- Working knowledge of ICH-GCP guidelines, FDA regulations, and IRB processes
- Experience building or managing recruitment performance dashboards or business intelligence reporting tools
- Prior experience mentoring, training, or providing informal leadership to team members
- Must have a dedicated, distraction-free remote work environment with reliable high-speed internet access
- Must be available during core business hours and responsive during study award notification periods regardless of time zone
Benefits:
- Dedicated, distraction-free remote work environment requirement
- Reliable high-speed internet access requirement
- Remote work arrangement
- Availability during core business hours with responsiveness during study award notification periods regardless of time zone
- Defined growth path to Associate Director, Patient Advocacy & Engagement
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