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. 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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