Study Start-Up Specialist

INNOVO RESEARCH INC • Champaign, IL

1d • $35 - $35

About The Position

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 coordinator works under the direction of the Head of Study Start-Up & Regulatory and collaborates with internal teams, investigational sites, sponsors, and vendors to ensure start-up tasks are completed accurately and on time.

Requirements

• 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)
• 1–3 years of experience in clinical research or a related administrative role
• Experience with regulatory documentation processes strongly preferred
• 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
• Working knowledge of ICH-GCP principles and regulatory documentation standards

Nice To Haves

• 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
• Experience with CTMS or similar systems preferred
• Direct study start-up experience is not required, provided the candidate has familiarity with regulatory documentation and clinical research workflows

Responsibilities

• 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

What This Job Offers

• Job Type: Part-time
• Career Level: Entry Level