Live opening · Posted 8 days ago
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About the role
Description supplied by the original job listing.
As part of Theradex Oncology, you will have the opportunity to work with one of the largest professional teams focused solely on the development of cancer therapies. Cancer research continues to evolve as new therapies and therapeutic approaches are discovered, as part of the team you will work to support our sponsors in the development of these therapies. Theradex Oncology is an environment for highly motivated individuals who want to make a difference.
We're looking for an Analyst, Contracts and Budgets to support the study startup team. This role will be responsible for all US clinical site contracting and budgeting activities.
The primary responsibilities of this position include, but are not limited to, the following:
Prepare, review, and negotiate site-specific Clinical Trial Agreements (CTAs), investigator budgets and amendments based on sponsor-approved master templates and negotiation parameters. To include analyzing protocols for detailed budget construction, reviewing protocol amendments for budget impacts, ensuring compliance with sponsor guidelines and FMV standards, and collaborating with sponsors and internal teams.
Serve as the primary contact for clinical sites regarding contract and budget issues, identifying and escalating concerns to management as needed.
Prepare, negotiate, execute, and track clinical site Confidentiality Disclosure Agreements (CDAs).
Focused review of financial and legal text within informed consent forms for accuracy and completeness; feedback to internal team and sponsors.
Track, update, and maintain contract status in relevant systems; collect and maintain performance metrics data related to contracts, budgets, and CDAs for reporting purposes.
Prepare status reports for internal team and sponsors as required.
Participate in internal, client/sponsor, and other meetings/presentations as required.
Review and contribute to relevant SOP updates related to confidentiality agreements and clinical site contracting.
Support Business Development with relevant information for proposals, bid defense and work orders/change orders.
Maintain electronic and paper contract files (as applicable), ensuring accuracy and accessibility.
Perform other duties as assigned by management.
Work arrangement
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