Clinical Research Nurse

3 days ago

Miami, United States Quotient Sciences Limited Full time

Posted Monday 23 September 2024 at 10:00 Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients. We employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA. Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community that’s focused on innovation and are driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast. The Role Responsible for coordinating, supervising and monitoring study activities, following adverse events and administering study medications. To comply & adhere to GCP guidelines and regulations as required of this role. To ensure study data is collected to a high quality in accordance with Good Clinical Practice (GCP) standards. To ensure subject safety at all times. Main tasks and responsibilities Responsible for administering study medication to study participants. Familiar with intravenous infusion techniques including pumps. Responsible for supervising staff and study events on the unit according to protocol requirements. Responsible for making staff adjustments during absences or other unanticipated work circumstances. Responsible for monitoring study schedules and reviewing study activities as they progress. Responsible for reviewing, recording and following adverse events. Responsible for confirming that a complete screening chart containing informed consents, lab results and Investigator approval is available on the day of admission for every admitted subject. Responsible for monitoring clinical results, compliance, and/or safety issues which would trigger the exclusion or discontinuation of a participant. Ability to effectively interact with pharmaceutical company representatives (monitors) and clinical research organizations (CRO) in response to queries during the course of the research study. Participates in key study meetings - SIV, Clinical Kick-off, paperwork review, dummy run and as required. Assures that all necessary source documents are available on the unit on a timely basis. Reviews study source documents for completion. Familiarity with crash cart emergency procedures. Responds to medical emergencies in clinic and to adverse events requiring urgent attention. Assists with other nursing duties as assigned. Additional Tasks/responsibilities Assists with new employee (regular and per diem) training by providing orientation to general study procedures and responsibilities. The Candidate BSN or RN with experience preferably within a critical care setting and/or clinical research environment. Current Advanced Cardiac Life Support (ACLS) certification. Computer proficient in Microsoft Office products (e.g. Outlook, Word). High attention to details. Excellent communication and interpersonal skills. Application Requirements When applying for a position with Quotient Sciences to be able to work in our organisation you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined. Our Commitment to Diversity, Equity and Inclusion Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organisation. As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. Specifically, we will not discriminate on the basis of race, colour, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws. This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination. #J-18808-Ljbffr

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