Study Start-Up Specialist (SSU) (3993)

The Study Start-Up Specialist (SSU) is responsible for supporting operational study startup activities across the clinical research network from study award through site activation. This role assists with startup coordination, document tracking, milestone follow-up, system updates, and communication between internal teams, sponsors, CROs, and research sites to support efficient and compliant study activation. The SSU Specialist works closely with SSU leadership, Regulatory, Clinical Operations, Clinical Data, sponsors, CROs, investigators, and site teams to support startup deliverables, dependencies, and timelines while maintaining workflow organization and operational consistency across assigned studies. This role focuses on operational execution, startup follow-up, documentation support, startup tracking, and maintaining timely communication throughout the startup lifecycle. 

DUTIES & RESPONSIBILITIES 

1. Study Start-Up Coordination & Activation Support 

• Support startup activities across assigned studies and network sites from study award through activation 
• Assist with tracking startup timelines, deliverables, milestones, and outstanding action items 
• Maintain startup trackers, activation logs, and operational documentation 
• Coordinate follow-up on pending startup tasks, approvals, and documentation requirements 
• Support the timely progression of startup activities according to sponsor expectations and internal timelines 
• Assist with scheduling startup meetings, activation discussions, and sponsor calls as needed 
• Support activation readiness activities and operational startup preparation 
• Escalate startup delays, missing items, or workflow barriers to SSU leadership appropriately 

2. Cross-Functional Startup Coordination 

• Coordinate with Regulatory, Clinical Operations, Clinical Data, PMO, sponsors, CROs, and site teams regarding startup activities 
• Provide startup status updates and operational follow-up communication to relevant stakeholders 
• Support the collection, organization, and follow-up of startup-related documentation and deliverables 
• Assist with sponsor, CRO, and site communications related to startup timelines and requirements 
• Follow up on startup action items and operational dependencies to support timely completion 

3. Startup Tracking, Reporting & Documentation 

• Update startup trackers, reporting tools, and operational systems accurately and promptly 
• Track outstanding approvals, startup dependencies, and aging deliverables 
• Prepare startup status updates and operational reports for leadership review 
• Ensure startup documentation is organized, complete, and maintained according to internal processes 
• Support reporting accuracy and operational visibility across assigned studies 

4. Risk Identification & Issue Escalation 

• Identify startup delays, operational concerns, or workflow gaps impacting startup timelines 
• Escalate outstanding issues or barriers impacting startup progress appropriately 
• Support follow-up on mitigation plans and operational action items 
• Assist with maintaining startup quality and operational readiness standards 

5. Process Consistency & Team Support 

• Follow standardized startup workflows, processes, and communication practices 
• Support onboarding and training activities for new SSU team members as assigned 
• Assist with the development and maintenance of startup trackers, workflow tools, and guidance documents 
• Participate in startup process improvement and operational efficiency initiatives 
• Promote accountability, organization, and operational consistency across assigned activities 

6. Other Duties 

• Perform additional operational responsibilities as assigned by management 

KNOWLEDGE & EXPERIENCE 

Education: 

• Associate’s or Bachelor’s degree in Life Sciences, Healthcare Administration, Business Administration, or related field preferred
• Equivalent clinical research experience may be considered 

Experience: 

• 1–3+ years of clinical research, startup coordination, regulatory support, or clinical operations experience preferred 
• Experience supporting startup timelines, documentation tracking, or operational workflows preferred 
• Experience working within a clinical research site, CRO, sponsor, or research network environment preferred 
• Experience coordinating multiple tasks and priorities in a fast-paced operational setting is preferred 

Credentials: 

• ACRP or SOCRA certification preferred but not required 

Knowledge and Skills: 

• Basic understanding of clinical trial startup workflows and activation processes 
• Working knowledge of clinical research operations and regulatory documentation preferred 
• Strong organizational and task management skills 
• Ability to manage multiple assignments, timelines, and operational follow-up activities simultaneously 
• Strong attention to detail and follow-through 
• Excellent verbal and written communication skills 
• Strong interpersonal and team collaboration skills 
• Ability to identify and communicate operational concerns appropriately 
• Experience with Microsoft Office Suite, Google Workspace, and startup tracking systems preferred 
• Ability to function effectively in a fast-paced, team-oriented operational environment 
• Ability to maintain professionalism and responsiveness with internal and external stakeholders