Remote Study Startup Specialist I

Bilinguallink; Windsor; Remote; CAD 65,000 - 85,000; Full time

Job summary

PSI is seeking a Study Startup Coordinator based in Windsor, Ontario. You will support site activation, feasibility research, and eTMF maintenance to ensure clinical projects start smoothly and on time.

You will assist with site agreements, budgets, and IP-RED processes, providing regular progress updates and escalating issues as needed. Collaboration across functions is essential for success.

Qualifications

• College/university degree or equivalent education, training and experience.
• At least 1 year in clinical research or Study Startup experience.
• Strong communication and organizational skills.
• Ability to negotiate and build relationships at all levels.

Responsibilities

• Supports site activation processes and ensures timely startup activities.
• Assists feasibility research and site identification.
• Maintains study startup tracking systems and eTMF throughout startup.
• Provides administrative support with site agreements and budgets.
• Collects site documents for IRB/IEC submission and IP-RED processes.
• Gives progress updates to all concerned functions.
• Escalates project-specific issues per plan.

Skills

Communication

Organizational skills

Education

College/University degree or equivalent

1 year clinical research / Study Startup experience

Job 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.

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 collectingdocuments 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/or 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.