CRA II

Fortrea; Warszawa; On-site; PLN 90,000 - 120,000; Full time

Job summary

Fortrea is seeking a permanent, full-time CRA II for Central or Southern Poland. The role offers exposure to diverse disease areas with opportunities for career progression.

You will monitor clinical sites, manage site activities per the project plan, and ensure proper training and regulatory compliance, including SAE reporting and data integrity through CRF review.

Qualifications

• Minimum 1.5 years of independent monitoring experience
• Experience in Oncology preferred but not required
• Fluent in English and Polish

Responsibilities

• Monitor all aspects of study site monitoring including routine monitoring and close-out of clinical sites
• Responsible for site management as prescribed in the project plan
• Ensure staff have proper training and materials to safely enter patients into the study
• Ensure informed consent and protocol requirements are adhered to
• Verify data integrity through CRF review and source data verification
• Monitor data for missing or implausible data
• Assist with training of new employees (e.g., co-monitoring)
• Coordinate designated clinical projects and act as local client contact when requested
• Track SAE reporting and production of reports and narratives
• Independently perform CRF review and query resolution

Skills

Study monitoring

Site management

Documentation

Quality control

Education

Life science degree

Nursing background

Job description

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 training, 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
• Participate in and follow up on Quality Control Visits (QC) when requested
• 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, when requested

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

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