Study Start-Up Specialist

This is a fully remote position, open to applicants in United States.

📋 Description

• Launch comprehensive study start-up activities following the receipt of study award notifications during the pre-award phase, including assisting the PAE Director with recruitment strategies.

• Manage and oversee the PAE study start-up task management system from Pre-Award through Greenlight Activation.

• Monitor workflow stages, assigned responsibilities, deadlines, escalation triggers, and process milestones.

• Supervise the execution of CTAs, SIV/Greenlight dates, IRB approvals, sponsor approvals, and collection of essential documents.

• Proactively raise any delays to the PAE Director.

• Collaborate with Contracts & Budgets on study awards, timelines for contract execution, and status of CTA signing.

• Act as the PAE point of contact to ensure that recruitment preparations are not hindered by contract finalizations.

• Provide mentorship to junior PAE start-up and recruitment coordinators.

• Identify bottlenecks in study start-up processes and spearhead initiatives for improvement, including updates to SOPs, workflow templates, and task management systems.

• Partner with the PAE Director to formulate department-wide start-up strategies.

• Represent PAE study start-up operations in discussions with cross-departmental leadership and deliver updates to senior stakeholders.

• Track, collect, and manage critical study start-up documents, such as protocols, ICFs, sponsor-required materials, and site-specific documents.

• Ensure that IRB and sponsor approvals are secured before distributing patient-facing recruitment materials.

• Coordinate with Regulatory on timelines for IRB submission and approval, ensuring recruitment materials adhere to IRB-approved language.

• Submit recruitment budget requests to Finance and monitor approved spending.

• Request budget amendments as necessary.

• Facilitate vendor payment processes while maintaining Google and Meta advertising vendors on an invoicing basis.

• Conduct mandatory 30-day recruitment performance evaluations for ongoing studies.

• Analyze recruitment start-up performance trends across the portfolio and present findings to the PAE Director.

• Collaborate with Business Development, Operations, Regulatory, Contracts & Budgets, Finance, and Site Management.

• Communicate confirmed Greenlight and SIV dates to the PAE team to synchronize patient matching, outreach scheduling, and mass text deployment.

⛳️ Requirements

• Bachelor’s degree in Healthcare Administration, Life Sciences, Business, Communications, Marketing, or a related discipline.

• A combination of education and directly relevant experience may be considered as equivalent.

• At least 3–5 years of experience in clinical research, patient recruitment, study start-up, or a related healthcare/CRO setting.

• Proven experience managing end-to-end workflows for clinical trial start-up.

• Demonstrated ability to coordinate across regulatory, contracts, finance, and operations teams.

• Capability to lead process improvement initiatives and contribute to strategic planning efforts.

• Skilled in tracking and managing essential study documents and regulatory approval processes, including IRB and sponsor approvals.

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

• Proficient in RealTime CTMS or a similar clinical trial management system.

• Proficiency in Microsoft Office Suite: Word, Excel, PowerPoint, and Outlook.

• Familiarity with Microsoft Planner, Teams, or similar 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 dedication to document accuracy and process compliance.

• Capability to work collaboratively across various departments and with external vendors.

• Availability to respond promptly upon receipt of study award notifications, including at the beginning of compressed CTA/SIV timelines.

• Working knowledge of ICH-GCP guidelines, FDA regulations, and IRB processes.

• Experience in developing or managing recruitment performance dashboards or business intelligence reporting tools.

• Prior experience in mentoring, training, or providing informal leadership to team members.

• Must possess a dedicated, distraction-free remote work environment with reliable high-speed internet access.

• Must be reachable during core business hours and responsive during periods of study award notifications, regardless of time zone.

🏝️ Benefits

• Requirement for a dedicated, distraction-free remote work environment.

• Requirement for reliable high-speed internet access.

• Remote work arrangement.

• Availability during core business hours with responsiveness during study award notification periods, irrespective of time zone.

• Clearly defined growth path to Associate Director, Patient Advocacy & Engagement.