CRA II

FTPOL Fortrea Poland Sp z o.o.; Warszawa; On-site; PLN 180,000 - 240,000; Full time

Job summary

Fortrea is recruiting a permanent, full-time CRA II to cover Central or Southern Poland. The role offers exposure to diverse disease areas and a clear path for advancement within the Fortrea team.

You will monitor sites, ensure protocol and regulatory compliance, and liaise with vendors, with opportunities to develop client interactions and cross-functional collaboration.

Qualifications

• Minimum 1.5 years of independent monitoring experience in international Pharma/CRO.
• Experience in Oncology preferred but not required; willingness to work on Oncology studies.
• Experience in interventional studies.
• Excellent understanding of Serious Adverse Event (SAE) reporting.
• Fluent in English and Polish.

Responsibilities

• Monitor study sites including routine monitoring and close-out, maintaining study files.
• Liaise with vendors and support site management per project plan.
• Ensure proper materials and trained staff for patient entry and protocol adherence.
• Prepare accurate and timely trip reports and oversee registry management.
• Recruit investigators, prepare EC submissions, notify regulatory authorities, and translate study documents.
• Support potential client-facing activities and SAE tracking.
• Perform CRF review and assist training of new employees.
• Coordinate designated clinical projects as Local Project Coordinator as assigned.

Skills

English language

Polish language

SAE reporting

Monitoring experience

Oncology experience

Interventional studies

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

• 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.

At Fortrea, we’re all about turning the ‘impossible’ into "I’m possible." Together, we break barriers to deliver exceptional service to our patients, fueled by a shared commitment to teamwork and excellence. Regardless of your role, we’re all family, working together to achieve extraordinary results. At Fortrea, your career isn’t just a job – it’s a journey of making the exceptional possible, every day.