Study Start-Up Specialist

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.