Senior CRA I /Senior CRA II - sponsor dedicated

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access, and technology solutions across more than 20 therapeutic areas.
Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.
With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.We are recruiting for our sponsor-dedicated business in Poland and are currently seeking to hire a Senior CRA I or Senior CRA II with a permanent and full-time contract.
In this role, you will be dedicated to a single sponsor.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 assignedResponsible for all aspects of site management as prescribed in the project planEnsure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the studyEnsure the protection of study patients by verifying that informed consent procedures and protocol requirements are adhered to according to the applicable regulatory requirementsEnsure the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful source document reviewMonitor data for missing or implausible dataEnsure 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 guidelinesEnsure audit readiness at the site levelPrepare accurate and timely trip reportsResponsible for all aspects of registry management as prescribed in the project plansUndertake feasibility work when requestedParticipate in and follow up on Quality Control Visits (QC) when requestedRecruitment 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 supervisorMight be requested to work in a client facing environmentTrack and follow up on Serious Adverse Event (SAE) reporting, process production of reports, narratives and follow up of SAEIndependently perform CRF review; query generation and resolution against established data review guidelines on Fortrea or client data management systems as assigned by managementAssist with training, of new employees, e.g.
co-monitoringCoordinate designated clinical projects as a Local Project Coordinator (with supervision, if applicable), and may act as a local client contact as assignedEducation 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 3.5 years of independent monitoring experience in international Pharma/CRO companyExperience in Oncology preferred but not a must; although you should be willing to work on Oncology studiesExperience in interventional studiesExcellent understanding of Serious Adverse Event (SAE) reportingFluent in English and PolishFortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials.
Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need.
Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact.
For more information about Fortrea, visit ***.Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind.
We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.
We encourage all to apply.
For more information about how we collect and store your personal data, please see our Privacy Statement.
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials.
We encourage all to apply.For more information about how we collect and store your personal data, please see our Privacy Statement.
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