Study Start Up Specialist (with Italian)

• 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. 

 

• 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 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. 

 

• 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.