Note: The job is a remote job and is open to candidates in USA. Theradex Oncology is a full-service contract research organization specializing in oncology clinical trials and programs. The Analyst, Contracts and Budgets supports the study startup team by managing U.S. clinical site contracting, budgeting, confidentiality agreements, financial and legal reviews, reporting, and related cross-functional activities.
Responsibilities
- 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
Skills
- Bachelor's degree, preferably in finance, accounting or another business-related field
- Working knowledge of ICH GCP guidelines and clinical research processes
- This position is not eligible for relocation or company provided sponsorship
- 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
Benefits
- Medical coverage
- Dental coverage
- Vision coverage
- Life insurance
- Disability insurance (STD/LTD)
- Company matched 401(k)
- Tuition reimbursement
- Generous vacation/sick plans
- Flexible work schedules
- Employee discounts
- Other company provided benefits
Company Overview