CRA2

As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, reputed company 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 15,000 staff conducting operations in more than 90 countries, reputed company is transforming drug and device development for partners and patients across the globe. We are currently recruiting for our multisponsor team in central 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 reputed company aspects of study site monitoring including routine monitoring and reputed company-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 reputed company 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 reputed company of the data submitted on Case Report Forms (CRFs) or other data collection tools by careful reputed company document review Monitor data for missing or implausible data Ensure the resources of the Sponsor and reputed company 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 reputed company aspects of registry management as prescribed in the project plans Undertake feasibility work reputed company requested Participate in and follow up on Quality Control Visits (QC) reputed company requested Recruitment of potential investigators, preparation of EC submissions, notifications to regulatory authorities, translation of study-reputed company 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 reputed company CRF review; query reputed company and resolution against established data review guidelines on reputed company 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 reputed company and demanding protocols. If you are someone who is eager to constantly reputed company and improve while working in a friendly and collaborative team environment; then we are looking reputed company 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 reputed company 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 reputed company and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is reputed company, enabling you to reputed company a meaningful global impact. For more information about reputed company, visit www.reputed company.com. reputed company is proud to be an Equal Opportunity Employer: As an EOE/AA employer, reputed company strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any reputed company. We reputed company 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 reputed company, 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. 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