Study Startup Specialist II
PSI CRO•Mississauga, ON
•CA$78,000 - CA$95,000
About The Position
Take your career to the next level and lead challenging study activation process on a country level. You will support clinical research teams and ensure PSI projects start smoothly and on time.
Requirements
- College/University degree in Life Sciences or an equivalent combination of education, training and experience
- At least 2 years of full-scope Study Startup experience.
- Full professional working proficiency in English and French.
- Well-developed communication and organizational skills
- Ability to negotiate and build relationships at all levels
Responsibilities
- Collaborate with the project team for site activation processes
- Facilitate site agreement, contract negotiations and budget negotiations
- Collect site documents for IRB/IEC submission and/or IP-RED process
- Coordinate translation and review of study-specific documents
- Identify and escalate project-specific issues as needed
- Prepare and submit the study dossiers to sites, competent authorities, IRBs/IECs
- Prepare IP-REDs packages
- Support initial distribution of Investigational Product(s) and clinical study supplies to sites
- Ensure exchange of information and documentation with investigational sites, off site facilities and vendors
- Participate in development of site-specific startup timelines and enrolment projections and is responsible for meeting the site activation targets
Benefits
- Extensive training
- Competitive salary and benefits package
- Opportunities for personal and professional growth
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
