Position Overview
The Study Start-Up Specialist plays a key role in ensuring timely activation of clinical trials at the research site. This individual manages all start-up activities from feasibility through site initiation, ensuring that regulatory, contractual, and operational requirements are met efficiently. The ideal candidate is detail-oriented, proactive, and capable of coordinating across multiple stakeholders — including sponsors, CROs, investigators, and internal site teams — to ensure trials launch on time and in compliance with GCP, FDA, and IRB regulations.
Key Responsibilities
Feasibility & Site Activation
- Review study feasibility questionnaires and coordinate completion with site leadership and investigators.
- Evaluate protocol requirements against site capabilities, resources, and patient population.
- Track and manage study activation timelines, identifying and resolving barriers to start-up.
Regulatory Submissions
Prepare, compile, and submit regulatory documents for IRB / EC approval (initial submission, continuing reviews, amendments).Maintain essential regulatory documents (1572, CVs, licenses, financial disclosures, delegation logs, etc.) in compliance with ICH-GCP and sponsor requirements.Ensure all staff credentials and trainings are current before site activation.Contracts & Budgets
Collaborate with management and sponsor / CRO representatives to facilitate budget negotiations and contract execution.Track progress of contract and budget approvals; maintain clear communication with both internal and external stakeholders.Support review of payment terms and milestone deliverables.Site Initiation Readiness
Coordinate pre-study visits, SIV scheduling, and logistical setup (lab kits, supplies, systems access, training completion).Ensure completion of site activation checklists and readiness documentation prior to FPFV.Partner with Clinical Research Coordinators and Regulatory staff to ensure seamless transition from start-up to study conduct.Compliance & Documentation
Maintain accurate study start-up trackers, databases, and regulatory binders (electronic or paper).Support audits and inspections by providing complete and accurate regulatory documentation.Ensure compliance with all internal SOPs, GCP, and applicable regulations.Qualifications
Education :
Bachelor’s degree in life sciences, healthcare, or related field required.Advanced degree (MS, MPH, PharmD, RN, or equivalent) preferred.Experience :
2+ years of experience in clinical research, preferably within a research site or site network environment.Prior experience in study start-up, regulatory affairs, or clinical trial coordination strongly preferred.Working knowledge of ICH-GCP, FDA, and IRB submission processes.Skills & Competencies :
Strong organizational and project management skills; ability to manage multiple start-up projects simultaneously.Excellent written and verbal communication skills.Proficiency in Microsoft Office Suite and clinical trial management systems (CTMS, eReg, eISF, etc.).Collaborative mindset with a proactive, solution-oriented approach.