🔥 10 hours ago
Coordinate clinical trial site contracting by negotiating budgets and agreements, preparing documents for execution, tracking progress, and keeping relevant teams informed throughout the site activation process.
Site Budget Specialist I
🕒 yesterday
📍 🇨🇴 Colombia - Remote🥁 Junior🏥 Clinical Operations Specialist📢 🇪🇸 Spanish Required📢 🇬🇧 English Required💼 Full-Time
Site Budget NegotiationClinical Trial Agreements (ctas)Investigator GrantsClinical Study Start-up
📜 Description
- Review and negotiate site budgets, clinical trial agreements, and investigator grants.
- Coordinate agreement and grant reviews among PSI Legal, project teams, and study sites.
- Prepare site-specific contract documents and executable agreements, and coordinate signatures.
- Track negotiation status in the Clinical Trial Management System (CTMS).
- Liaise with project, translation, and legal teams; support other Study Startup activities as needed.
🛠️ Requirements
- College/University degree or an equivalent combination of education, training & experience
- Fluency in Spanish and English, oral and written
- Previous experience working with study startup operations is required
- Experience with finance and negotiation is desirable
- PC skills to be able to work with MS Word, Excel and PowerPoint
- Ability to plan and work in a dynamic team environment
- Communication and collaboration skills
- File executed contracts in the Trial Master File and maintain local documentation.
Full job description
Company Description
We are the company that cares – for our staff, for our clients, for our partners and for the quality of work we do. A dynamic, global company founded in 1995, we bring together more than 2,700 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
Job Description
Join our LatAm team to be the key support to clinical research projects as part of the start-up team. You will work in a dynamic multi-functional environment, gaining unique skills from various disciplines relevant to clinical research.
Home-based position in Colombia.
Only CVs in English will be considered.
You will:
- Review and negotiate site budgets
- Facilitate the review and negotiation of clinical trial agreements (CTAs) and investigator grants between PSI Legal, the project team, and the study site
- Customize and prepare contractually binding site-specific documents in cooperation with PSI Legal
- Track CTA and investigator grant negotiation status in the Clinical Trial Management System (CTMS)
- Prepare the executable version of the contract, including grants, and coordinates the signature process
- File executed contracts in the Trial Master File and maintains local documentation
- Liase with the project team, translation, and legal departments on site contracting and grant negotiation matters
- Support the activities of Study Startup team if needed
Qualifications
- College/University degree or an equivalent combination of education, training & experience
- Fluency in Spanish and English, oral and written
- Previous experience working with study startup operations is required
- Experience with finance and negotiation is desirable
- Knowledge and experience with legal documents related to clinical trial sites would be considered a plus
- PC skills to be able to work with MS Word, Excel and PowerPoint
- Ability to plan and work in a dynamic team environment
- Communication and collaboration skills
Additional Information
Our mission is to be the best CRO in the world as measured by our employees, clients, sites, and vendors. Our recruitment process is easy and straightforward, and we’ll be there with you every step of the way.
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