Manage clinical site start-up activities: prepare and distribute start-up packages, track site timelines and metrics in Smartsheet/CTMS, support contract and budget negotiations, maintain site intelligence trackers, liaise with sites and internal teams (Project Management, Regulatory, Contracts/Legal), and provide project management support to ensure timely regulatory and IRB compliance.
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.
Role and Responsibilities:
1. 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.
2. 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.
3. 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.
4. 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 activities.
• 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 IRB 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 documentation.
• Provide support to project management with study related activities as required.
Qualifications:
- Undergraduate university degree (Bachelor or Honors Bachelor) and Minimal Training (brief orientation or introductory training); less than 1 years' related experience;
- Or College Diploma/Degree and 1-3 years' related experience with initial and On-going training.
Other:
- 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.
- Some financial responsibility (handling of small cash floats, minimal spending limits, can provide input during department budget creation).
- Sets personal pace and content (significant scope for setting pace and action order within the context of tasks to complete).
- Large number of regular contacts (team/unit members/vendors/clients, occasionally difficult, requiring patience and tact).
- English and Italian language skills.
Working Conditions:
- Home-based.
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*Accommodations for job applicants with disabilities are available upon request.
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