CRA II

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.