We are currently recruiting for our multisponsor team in Central or Southern Poland and are looking to hire a permanent, full-time CRA II.
Our positions offer excellent exposure to a range of disease areas, and a real opportunity for career progression and promotion in time.
Responsibilities include but are not limited to:
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 assigned
Responsible for all aspects of site management as prescribed in the project plan
Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study
Ensure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirements
Ensure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document review
Monitor data for missing or implausible data
Ensure the resources of the Sponsor and Fortrea are spent wisely by performing the required monitoring tasks in an efficient manner, according to SOPs and established guidelines
Ensure audit readiness at the site level
Prepare accurate and timely trip reports
Responsible for all aspects of registry management as prescribed in the project plans
Undertake feasibility work when requested
Participate in and follow up on Quality Control Visits (QC) when requested
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
Might be requested to work in a client facing environment
Track and follow up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAE
Independently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by management
Assist with training, 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 and Qualifications:
We are searching for a university graduate with a life science degree or nursing background who relishes working in a fast paced environment, on complex and demanding protocols.
If you are someone who is eager to constantly develop and improve while working in a friendly and collaborative team environment; then we are looking forward to meeting you.
Minimum 1,5 years of independent monitoring experience in international Pharma/CRO company
Experience in Oncology preferred but not a must; although you should be willing to work on Oncology studies
Experience in interventional studies
Excellent understanding of Serious Adverse Event (SAE) reporting
Fluent in English and Polish
Learn more about our EEO & Accommodations request here.
University degree in life science or nursing; minimum 1.5 years independent monitoring experience in international pharma/CRO; experience in interventional studies; excellent understanding of SAE reporting; fluent English and Polish.
Key Responsibilities
- monitoring clinical sites
- managing site data
- ensuring regulatory compliance
Job Details
- Category: Research and Development (R&D)
- Seniority: Entry Level
- Commitment: Full Time
- Workplace: Remote — Poland
- Languages: English, Polish
About Fortrea
A global clinical research organization advancing life-saving therapies for patients worldwide. — Industry: Research and Development