Company Description
We are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together more than 2,800 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 international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents & information.
Only CVs in English will be accepted.
You will be responsible for:
- Being the main point of contact between site personnel and CRA involved in the project helping on query resolution and EDC completion
- Serves as the primary sites’ contact point for vendors, study supplies, and access management
- Ensure that pre-study testing (scans, MRI/CT qualification questionnaires, test ECGs, etc.) of local site facilities is completed
- Assists the Monitors in their prompt completion of all subject event and site event information in CTMS. Track the resolution status of site issues and action items in CTMS
- Act as the one who will ensure the order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies
- Ensures regulatory and ethics committee submissions and notifications, meaning you will need to be up to date on local regulations and dispositions
- Coordinate preparation for and follow-up on site, TMF and systems´ audits and inspections
- Manage the TMF on a site and a country level regularly and file documents. Prepare, distribute, and update Investigator Site Files (ISF) and ISF checklists
- Arrange and track initial and on-going project training for site teams in all vendor-related systems
- Document Management and translations status review of the study
- Ensures proper safety information flow with investigative sites
Qualifications
- College/University Degree in Life Sciences;
- Administrative work experience, preferably in an international settings;
- Prior experience working as CTA for CROs;
- Prior experience working in Clinical Research;
- Local regulations knowledge;
- Full working proficiency in English and Spanish;
- Proficiency in MS Office applications;
- Ability to plan and work in a dynamic team environment;
- Communication and collaboration skills.
Additional Information
Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with the company.
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
