Job Description

Job Location: 206 W WHITE STREET - CHAMPAIGN, IL 61820
Position Type: Part Time
Salary Range: $35.00 - $35.00 Hourly

Position Summary
The Study Start-Up Specialist provides administrative and operational support for clinical study activation activities. This role is responsible for coordinating documentation, tracking start-up milestones, and supporting regulatory, contractual, and site activation processes to ensure studies progress efficiently toward activation. The Study Start-Up Specialist will report to Feasibility and Study Start-up Manager and collaborates with internal teams, investigational sites, sponsors, and vendors to ensure start-up tasks are completed accurately and on time.
Key Responsibilities
Study Start-Up Administration & Coordination
- Provide administrative support for study start-up activities from feasibility through site initiation
- Assist with feasibility submissions
- Complete ICF reviews and IRB submissions
- Support study activation checklist completion
- Maintain and update study start-up trackers, timelines, and documentation under manager guidance
- Assist with site readiness activities, including collection and organization of required documents
- Support study activation by ensuring required tasks and dependencies are tracked and escalated as needed
- Coordinate with central regulatory teams to collect, track, and submit essential regulatory documents (e.g., investigator packets, essential documents, IRB/EC materials)
- Ensure regulatory documents are complete, accurate, and filed appropriately in study systems
- Track regulatory submission and approval status and report progress to the manager
- Support study start-up logistics by tracking status of contracts, budgets, and approvals
- Assist in coordinating timelines related to IRB approval, site activation, and site initiation visits (SIVs)
- Maintain documentation related to study start-up milestones and readiness activities
- Serve as a point of contact for routine start-up communications with sponsors, CROs, internal teams, and sites
- Distribute study-related communications and follow up on outstanding administrative items
- Participate in study start-up and internal team meetings as needed to provide status updates
- Follow established SOPs, workflows, and start-up procedures
- Assist with maintaining study start-up tools, templates, trackers, and shared documentation
- Identify administrative gaps or inefficiencies and flag them to the manager for review

QualificationsEducation
- Bachelor’s degree in Life Sciences, Health Sciences, Nursing, Pharmacy, or a related field preferred
- (Equivalent clinical research experience may be considered in lieu of degree)
Experience
- 1–3 years of experience in clinical research or a related administrative role
- Experience with regulatory documentation processes strongly preferred
- Background as a Research Assistant, Clinical Trial Assistant (CTA), Clinical Trial Associate (CTA), or entry-level CRO role is highly suitable
- Prior experience in an SMO, CRO, pharmaceutical, or biotechnology environment preferred
- Direct study start-up experience is not required, provided the candidate has familiarity with regulatory documentation and clinical research workflows
Skills & Competencies
- Strong organizational and administrative skills with high attention to detail
- Ability to manage multiple tasks, timelines, and studies simultaneously
- Comfortable working in a structured, deadline-driven environment
- Strong written and verbal communication skills
- Proficiency with Microsoft Excel and document tracking tools
- Experience with CTMS or similar systems preferred
- Working knowledge of ICH-GCP principles and regulatory documentation standards