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 DescriptionJoin 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 Mexico.
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
- 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
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.
Skills Required
- College or university degree, or equivalent combination of education, training, and experience
- Fluency in Spanish and English, both oral and written
- Previous experience working with study start-up operations
- Experience with finance and negotiation
- Knowledge and experience with legal documents related to clinical trial sites
- PC skills using Microsoft Word, Excel, and PowerPoint
- Ability to plan and work in a dynamic team environment
- Communication and collaboration skills
What We Do
PSI is a leading full-service global Contract Research Organization whose key strength is predictable patient enrollment across multiple therapeutic areas. PSI is known in the industry as a CRO focused on ‘on-time project delivery’. This is achieved through investing substantial effort and MD resources into performing quality feasibility assessments that provide an accurate predictor of study timelines. PSI’s global reach allows us to run clinical trials across multiple continents, in 50+ countries around the world. PSI’s reputation is that of a 'no-nonsense' CRO focused on timely patient enrollment and project delivery. An exceptionally high repeat and referral business rates alongside low staff turnover are indicative of our commitment to be the best CRO in the world as measured by our clients and our employees. http://www.psi-cro.com
