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 2.900 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.
Site Management
- Exchanges data, documents and other project relevant information between investigative sites, site vendors and the project team
- Ensures order, receipt, inventory storage, distribution, return/recall and reconciliation of clinical supplies
- Assists with handling administrative financial tasks
- Coordinates preparation for and follow-up on site, TMF and systems´ audits and inspections
Other Communication
- Exchanges data, documents, and other information with the project team and other departments
- Provides assistance with organization of internal team meetings
- Prepares draft minutes of internal team meetings
- Assists with preparation, attendance and follow-up of Investigator’s Meetings, as applicable
- Under supervision, maintains study-specific and corporate tracking systems
Document Management
- Maintains Trial Master File (TMF)
- Perform TMF review and oversight at country and site level
- Prepares, distributes, and updates Onsite Study Files (OSF) and OSF checklists
- Provides assistance with translations
Safety Management
- Ensures proper safety information flow with investigative sites
Other Assistance
- Provides miscellaneous administrative project support (if applicable)
Qualifications
- College/University Degree (Life Sciences)
- Full working proficiency in Czech and English
- Prior administrative experience in Clinical Research / CRO environment, preferably in an international setting
- Proficiency in standard MS Office applications
- Good organizational and planning skills, problem-solving abilities, 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
Additional Information
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.
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
