Study Start-Up Specialist

Job Description

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

Contracts & Budgets

Site Initiation Readiness

Compliance & Documentation

Qualifications

Education :

Experience :

Skills & Competencies :