Study Start Up Specialist

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  • Company Alimentiv
  • Employment Full-time
  • Location 🇺🇸 United States, Michigan
  • Submitted Posted 2 days ago - Updated 9 hours ago

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


€39,500 - €66,000 a year
+ Bonus

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*Accommodations for job applicants with disabilities are available upon request.

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