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PSI CRO

via Smartrecruiters

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Study Startup Specialist I

Anywhere
full-time
Posted 9/12/2025
Direct Apply
Key Skills:
Communication Skills
Organizational Skills
Negotiation
Relationship Building
Clinical Research
Study Startup
Feasibility Research
Site Activation
Project Tracking
Administrative Support
IRB Submission
Documentation
Audit Preparation

Compensation

Salary Range

$Not specified

Responsibilities

The Study Startup Specialist I will support all processes critical for site activation and assist with the feasibility research and site identification process. They will maintain project-specific tracking systems and ensure smooth and timely startup of clinical projects.

Requirements

Candidates should have a college/university degree or equivalent experience, along with at least one year of industry experience in clinical research and study startup. Strong communication and organizational skills are essential, as well as the ability to negotiate and build relationships.

Full Description

Company Description PSI is a leading Contract Research Organization with more than 29 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications. Job Description Take your career to the next level and be involved in study startup processes in the US. You will provide direct operational support to project teams and ensure that PSI clinical projects start smoothly and on time. Home-based in the United States You will: Supports all processes critical for site activation. Supports Feasibility department with feasibility research and site identification process. Maintains project-specific tracking systems and electronic Trial Master File (eTMF) throughout study startup phase. Provides administrative support with site agreement and budgets. Assists with site documents collection for IRB/IEC submission and/or IP-RED process. Provides progress updates to all concerned functions. Identifies project-specific issues and escalates as outlined in the project specific Communication Plan. Supports preparation of study dossiers to sites and competent authorities. Supports preparation of IP-RED packages. Ensures exchange of information and documentation with investigational sites, off -site facilities and vendors throughout study startup phase. Additional responsibilities may include collecting documents in preparation for audits on a country-region level. Qualifications College/University degree or an equivalent combination of education, training and experience At least 1 year industry experience in clinical research and a minimum 1 year of Study Startup experience​ Communication and organizational skills Ability to negotiate and build relationships at all levels Additional Information Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success.

This job posting was last updated on 9/13/2025

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