Study Startup Specialist I at PSI CRO

, , United States -

Full Time

Start Date

Immediate

Expiry Date

10 May, 26

Salary

0.0

Posted On

09 Feb, 26

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Communication Skills, Organizational Skills, Negotiation, Relationship Building, Clinical Research, Study Startup, Feasibility Research, Site Identification, Project Tracking, Administrative Support, IRB Submission, Documentation, Audit Preparation

Industry

Pharmaceutical Manufacturing

Description

Company Description PSI is a leading Contract Research Organization with more than 30 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.

Responsibilities

The Study Startup Specialist I supports all processes critical for site activation and provides operational support to project teams to ensure smooth and timely startup of clinical projects. Responsibilities include maintaining tracking systems, assisting with site documents, and providing updates to relevant functions.