Support Project Management, Regulatory, and Contract and Legal in all site-related start-up activities. Establish relationships with study personnel at sites and act as main Alimentiv contact during site start-up. 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.
Site Start-Up Packages
- 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 conjunction with Regulatory Affairs, ensure that the correct and complete packages are obtained within the planned timelines.
Site Contract and Budget Negotiation
- 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.
Site Intelligence Tracking
- Maintain site intelligence tracker with data related to specific requirements for study sites such as start-up timelines, budget, contract negotiation timelines and prerequisites, patient recruitment data, etc.
- Provide input for suggested site list during start-up using past experiences with potential study sites.
Site Start-Up Planning and Tracking & Project Management support
- 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 based on previous start-up metrics, as well as regulatory and /RB timelines.
- Track progress of start-up activities in smart sheet and/or CTMS.
- Maintain up to date knowledge, ensure adherence and compliance with local regulatory requirements and associated documentations.
- Provide support to project management with study related activities as required.
Qualifications
- 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. Very high sense of urgency.
Working Conditions
- Home-based
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