Analyst, Contracts and Budgets

Theradex Oncology•Princeton, NJ

9d•$75,000 - $105,000

About The Position

Theradex Oncology is a full-service CRO specializing in oncology, managing global oncology trials and programs. Founded in 1982, the company has expanded to work with industry sponsors developing cancer therapeutics. As a service-based company, Theradex supports both domestic and international sponsors in conducting early and late-phase trials. This role is for an Analyst, Contracts and Budgets to support the study startup team, responsible for all US clinical site contracting and budgeting activities.

Requirements

Bachelor’s degree, preferably in finance, accounting or another business-related field.
Minimum of 2-3 years of experience in clinical research preferred, specifically focused on site contracts and budget negotiation within a CRO, pharmaceutical company, or academic medical center.
Working knowledge of ICH GCP guidelines and clinical research processes.

Responsibilities

Prepare, review, and negotiate site-specific Clinical Trial Agreements (CTAs), investigator budgets and amendments based on sponsor-approved master templates and negotiation parameters. This includes 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.