- 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
- Minimum 3.5 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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Senior CRA I - Warsaw, Polska - Fortrea
Opis
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:
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.
Fortrea 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.
Użytkownicy zawodu Senior CRA I w Warsaw
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Kuldeep Singh
Aspiring to handle managerial position in accounts with an organisation of repute, where I can share ...