Site Budget Specialist I

Psi CRO; Bogotá; Remote; COP 28,000,000 - 44,000,000; Full time

Job summary

Psi CRO is seeking a highly organized Study Startup Specialist to support LatAm clinical trials from home in Colombia. You will collaborate across PSI Legal, project teams, and sites to negotiate CTAs and investigator grants, track status in CTMS, and prepare binding site documents.

The role requires fluent Spanish and English, a degree, and experience in study startup operations. You will coordinate with legal, translation, and study teams to ensure timely site contracting and grant

Qualifications

• Degree or equivalent education and training.
• Fluency in Spanish and English, written and spoken.
• Experience in study startup operations required.
• Finance and negotiation experience desirable.
• Knowledge of clinical trial site documents is a plus.
• MS Word, Excel, PowerPoint proficiency.
• Ability to work in a dynamic team.
• Strong communication and collaboration skills.

Responsibilities

• Review and negotiate site budgets.
• Negotiate CTAs and investigator grants.
• Customize and prepare site documents with PSI Legal.
• Track CTA and grant status in CTMS.
• Prepare executable contracts and coordinate signatures.
• File contracts in the Trial Master File and maintain docs.
• Coordinate with project, translation, and legal teams.
• Support Study Startup activities as needed.

Skills

Spanish fluency

English fluency

Communication skills

Teamwork

Education

Bachelor's degree or equivalent

Tools

MS Word

Excel

PowerPoint

Job 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 tobe the key support to clinical research projects aspart of the start-up team. You willworkin 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 sitebudgets
• Facilitate the review and negotiation of clinical trial agreements (CTAs) and investigator grants between PSI Legal, the project team, and the study site
• Customizeand prepare contractually binding site-specific documents in cooperation with PSI Legal
• TrackCTA and investigator grant negotiation status in the Clinical Trial Management System (CTMS)
• Preparethe executable version of the contract, including grants, and coordinates the signature process
• Fileexecuted contracts in the Trial Master File and maintains local documentation
• Liasewith 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 Spanishand 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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