Study Startup Specialist I
Job Description
Job Description
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 DescriptionTake 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 collecting documents in preparation for audits on a country-region level.
- 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.
How to Apply
Ready to start your career as a Study Startup Specialist I at PSI CRO?
- Click the "Apply Now" button below.
- Review the safety warning in the modal.
- You will be redirected to the employer's official portal to complete your application.
- Ensure your resume and cover letter are tailored to the job description using our AI tools.
Frequently Asked Questions
Who is hiring?▼
This role is with PSI CRO in Mississauga.
Is this a remote position?▼
This appears to be an on-site role in Mississauga.
What is the hiring process?▼
After you click "Apply Now", you will be redirected to the employer's official site to submit your resume. You can typically expect to hear back within 1-2 weeks if shortlisted.
How can I improve my application?▼
Tailor your resume to the specific job description. You can use our free Resume Analyzer to see how well you match the requirements.
What skills are needed?▼
Refer to the "Job Description" section above for a detailed list of required and preferred qualifications.