Job Overview :
We are currently looking for talented CRA I / CRA II to join our team in Poland.
Are you passionate about growing in Clinical Field? We are proud to have an excellent team of the best professionals on the market and are looking for people who are ready to show true performance and interest in Clinical Trials.
Do you like responsibilities and challenges? As a Clinical Research Associate you will lead all aspects of study site monitoring according to Covance SOP, ICH guidelines and GCP.
You will take part in pre-study qualification and initiation visits, routine monitoring, close-out of clinical sites, and maintenance of study files.
You will become a part of our team who is always ready to help. We offer a home based position so you will not spend time on unnecessary travels but at the same time we highlight a true live relationship between colleagues.
You will have a possibility to devote all your professional skills and knowledge into monitoring investigational sites as we organize our work environment and responsibilities with high standards.
Responsibilities include :
Responsible for all aspects of study site monitoring including routine monitoring and close-out of clinical sites, maintenance of study files, conduct of pre-study and initiation visits;
liaise with vendors; and other duties, as assignedResponsible for all aspects of site management as prescribed in the project plans
General On-Site Monitoring Responsibilities
Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-related documentation, organization of meetings and other tasks as instructed by supervisor as assigned
Assist Senior CRA with managing investigator site budgets
Track and follow-up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEs
Independently perform CRF review; query generation and resolution against established data review guidelines on Covance or client data management systems as assigned by management
Assist with training, mentoring and development of new employees, e.g. co-monitoring
Coordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assigned
Education / Qualifications :
University or college degree, or certification in a related allied health profession from an appropriately accredited institution (e.g., nursing licensure)
Basic knowledge of Regulatory Guidelines
Basic understanding of the clinical trial process
Fluent in local office language and in English, both written and verbal
Preferred : Experience :
experience in a related role (e.g. site management, in-house CRA, study coordinator, research nurse, etc.)
Basic understanding of Regulatory Guidelines
Ability to work within a project team
Good planning, organization and problem solving skills
Good computer skills with good working knowledge of a range of computer packages
Works efficiently and effectively in a matrix environment
Valid Driver's License
on site monitoring experience