Study Startup Specialist I
Share
Job Location:
Monthly Salary:
Posted on:
30+ days ago
Vacancies:
1 Vacancy
Job Summary
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 Canada
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/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.
Remote Work :
Yes
Employment Type :
Full-time
Key Skills
- Sales Experience
- Crane
- Customer Service
- Communication skills
- Heavy Equipment Operation
- Microsoft Word
- Case Management
- OSHA
- Team Management
- Catheterization
- Microsoft Outlook Calendar
- EHS
About Company
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on on-time project delivery. This is achieved through investing substantial effo ... View more
