Study Start-Up Specialist

Position Summary

The Study Start-Up Specialist is responsible for leading end-to-end study start-up activities across the Patient Advocacy and Engagement (PAE) department, ensuring all recruitment infrastructure, regulatory approvals, and cross-functional workflows are in place and ready for activation prior to site Greenlight. This role serves as the central coordinator between Business Development, Regulatory, Contracts and Budgets, Finance, Operations, and Site Management teams, driving accountability, timeline adherence, and readiness across every stage of the study start-up lifecycle. By owning the PAE start-up workflow from pre-award through Greenlight activation, the Study Start-Up Specialist directly enables faster study activation, stronger recruitment performance, and a more consistent and compliant patient engagement experience across the organization. This role is structured with a defined growth path to Associate Director, Patient Advocacy & Engagement, for individuals who demonstrate strong process leadership, cross-functional influence, and strategic ownership of the start-up function.

Key Responsibilities

Study Start-Up & Workflow Management

• 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.

Leadership & Process Improvement

• 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.

Essential Documents & Regulatory Compliance

• Track, collect, and manage all essential study start-up documents, including protocols, ICFs, sponsor-required materials, and site-specific documentation, ensuring all materials are received, organized, and accessible to the PAE team prior to outreach initiation.
• Ensure IRB approval and sponsor approval are obtained and confirmed before any patient-facing recruitment materials are deployed, including advertising campaigns, phone scripts, landing pages, and any other recruitment materials maintaining a clear approval status log for each study.
• Coordinate with the Regulatory team to monitor IRB submission and approval timelines, flag delays that could impact Greenlight readiness, and ensure all recruitment materials reflect the IRB-approved language.

Budget & Financial Coordination

• Submit recruitment budget requests to Finance at study award, including estimated advertising spend, vendor costs, and anticipated recruitment expenses; track approved spend throughout the study lifecycle and submit budget amendment requests as needed.
• Support vendor payment processes by ensuring digital advertising vendors (Google, Meta) are transitioned to and maintained on an invoicing model, and that all spend is accurately tracked and reconciliation ready.

Performance Tracking & Reporting

• Conduct mandatory 30-day recruitment performance reviews for all active studies beginning 30 days post-enrollment open, assessing study start-up timeline.
• Synthesize recruitment start-up performance trends across the study portfolio and present findings and actionable recommendations to the PAE Director to inform department-wide strategy.

Cross-Functional Coordination

• Serve as the primary PAE point of contact for cross-functional study start-up coordination with Business Development, Operations, Regulatory, Contracts & Budgets, Finance, and Site Management teams, ensuring clear communication, accountability, and timely handoffs at every process step.
• Communicate Greenlight and SIV dates to the full PAE team upon confirmation, ensuring downstream patient matching, outreach scheduling, and mass text deployment are timed appropriately.

Required Qualifications:

Education & Experience

• 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)
• Experience working with or alongside Contracts & Budgets teams on clinical trial agreement execution and study award processes

Technical Skills/Systems Experience

• Proficiency in RealTime CTMS (or comparable clinical trial management system)
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
• Experience with Microsoft Planner, Teams, or equivalent project management tools
• Experience with IRB submission portals and regulatory tracking tools/processes

Other Requirements (e.g., ability to travel, schedule flexibility, etc.)

• 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

Preferred Qualifications:

• Experience in a multi-site clinical research network
• Prior experience in a patient recruitment, patient advocacy, or patient engagement functions
• 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.

Core Competencies / Skills

• Project & Process Management — Ability to own and drive complex, multi-stakeholder workflows from initiation to completion; skilled at task prioritization, milestone tracking, and deadline management across concurrent studies
• Communication & Stakeholder Influence — Strong written and verbal communication skills across all levels of the organization; able to clearly convey status, risks, and recommendations to leadership and cross-functional partners
• Leadership & Mentorship — Provides guidance and direction to junior team members and cross-functional partners; builds credibility as a subject-matter expert and contributes to team development as the scope of the role grows
• Attention to Detail & Compliance Mindset — Rigorous approach to document accuracy, regulatory approval tracking, and protocol-aligned content review; understands the importance of IRB and sponsor approval prior to deployment
• Cross-Functional Collaboration — Skilled at building working relationships across departments (Regulatory, Finance, C&B, Operations, Sites); proactive communicator who ensures clear handoffs and accountability at every process step
• Data-Driven Decision Making — Comfortable reviewing recruitment performance metrics, budget spend reports, and lead conversion data to identify trends, flag concerns, and recommend strategy adjustments
• Urgency & Adaptability — Thrives in a fast-paced, timeline-driven environment; able to pivot quickly when CTA and SIV timelines compress and begin work immediately upon study award notification