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 3,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.
This role is hybrid - Based in Bucharest
Job DescriptionJoin our international team and be the key support to clinical research projects, streamlining communication, maintaining systems and managing documents & information.
Communication and Site Management
- Exchanges data, documents and other project relevant information between investigative sites, site vendors and the project team, and with other PSI departments
- Ensures order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies
- Ensures proper administration of sites and vendors payments, as applicable
- Ensures regulatory and ethics committee submissions and notifications
- Coordinates preparation for and follow-up on site, TMF and systems´ audits and inspections
- Supports the organization of internal team meetings including preparation of agendas and minutes, and also of Investigator’s Meetings
- Maintains study-specific and corporate tracking systems
Document Management
- Maintains Trial Master File (TMF)
- Performs TMF review and oversight at country and site level
- Prepares, distributes, and updates Investigator Site Files (ISF) and ISF checklists
- Revises and checks translation status
Safety Management
- Ensures proper safety information flow with investigative sites
- College/University Degree (preferably Life Sciences)
- Proficiency in standard MS Office applications
- Proficiency in English
- Good organizational and planning skills, problem-solving abilities, and flexibility
- Detail-oriented, able to multi-task and work effectively in a fast-paced environment
- Team-oriented with excellent customer service and interpersonal skills, including a positive attitude to tasks and projects
Make the right call and take your career to a whole new level. Join the company that focuses on its people and invests in their professional development and success. Our recruitment process is easy and straightforward, and we’ll be there with you every step of the way. We will guide and support you with information, making your experience as smooth as possible.
Top 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
