Study Start Up Specialist (with Italian)

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.

1. 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.

1. 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.

1. 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.