Contracts Specialist drafting, negotiating, and managing agreements for Fidus, a high - tech electronic design firm. Ensuring legal compliance across Canada and the United States.
About the role
- Site Budget & Contracts Specialist preparing clinical trial budgets and negotiating agreements for Fortrea’s global clinical research team. Home-based in the USA or Canada.
Responsibilities
- Prepare country site budgets and study financial appendices
- Assist with negotiation of site agreement budgets and financial exhibits of a certain complexity
- Develop Clinical Trial Agreements (CTAs) using standard templates and Contract Information Sheets
- Ensure CTAs are executed timely to meet study start-up timelines
- Liaise with legal departments regarding CTA content changes and approved agreement language
- Participate in study kick-off meetings
- Review proposed CTA language modifications and resolve compliance issues with legal, sites, contractors, or vendors
- Generate site budgets from approved country budgets and follow up with investigators
- Research medical procedure costs using local or global databases
- Manage CTAs and update agreement components according to client legal standards and Global SOPs
- Coordinate annual template reviews with Legal and Local Head of Monitoring and Site Management
- Manage the contract tracking database and reconcile document/database discrepancies
- Post fully executed contracts in eFiliA and on the Clinical Operations secure drive
- Process internal approval forms and other documents for compliance and annual audits
- Serve as point person among clinical trial site personnel, client Clinical Operations, Legal Counsel, and Manager, Insurance
- Prepare for internal audits by maintaining complete and accurate negotiation records
- Negotiate Master Services Agreements (MSAs) with institutions and ensure review before renewal dates
Requirements
- Must have a Bachelors’ degree or an equivalent scientific or commercial Higher Vocational education
- Experience in the healthcare field, pharmaceutical industry or clinical research preferred
- Solid understanding of standard contract language
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf
- Ability to sit for extended periods and operate a vehicle safely
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists
- Occasional crouching, stooping, with frequent bending and twisting of upper body and neck
- Light to moderate lifting and carrying objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Regular and consistent attendance
- Varied hours may be required
- Frequent travel to clients/site locations with occasional domestic and international travel
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Short-term disability (STD)
- Long-term disability (LTD)
- 401(K)
- Employee Stock Purchase Plan (ESPP)
- Paid time off (PTO) or Flexible time off (FTO)
- Company bonus where applicable
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