Study Start-Up Specialist

Summary

The job is for a Site Start-Up Coordinator at Alimentiv. The role involves supporting various departments in site-related start-up activities, negotiating budgets, maintaining site intelligence tracker, and acting as main point of contact for sites during start-up.

Requirements

• Applicants should have a minimum of one to three years of related work experience with ongoing training, or a minimum of a one-year College Advance Diploma/Degree in a relevant field of study, preferable in Health or Life Sciences, or Clinical Research
• The successful candidate must exhibit the following skills: Excellent communication skills. Knowledge of start-up requirements for clinical sites. Experience in working directly with clinical study sites through previous involvement in studies

Responsibilities

• Prepare, distribute and follow-up on start-up documents with sites
• Plan and track site start up activities and data using designated systems and tools
• Provide reports on intelligence and metrics related to study start-up activities
• In cooperation with Project Management, create study-specific start-up document package
• Distribute and follow up with sites to obtain the required executed documents
• Review content and correctness of returned documents from the sites, in accordance with internal standards
• In co-operation with Contract and Legal, obtain feedback on suggested site and investigator contract language
• Act as main point of contact for sites to obtain feedback on budget and contract negotiations
• In conjunction with the Project Manager, provide sites with the suggested study budget and negotiate within pre-approved margins
• Maintain site intelligence tracker with data related to specific requirements for study sites
• Provide input for suggested site list during start-up using past experiences with potential study sites
• Act as main contact for study sites during start-up
• Develop and maintain relationships with study sites that will facilitate timely completion of start-up
• In conjunction with project management and CRAs, plan start-up actions and provide expected SIV dates for individual sites
• Track progress of start-up activities in smart sheet and/or CTMS

Benefits

Home-based