Raleigh, NC, 27608, USA
22 days ago
Senior Clinical Research Associate - Organ Transplantation (East Coast)
California, US residents click here (https://www.unither.com/docs/UNITHER%20Applicant%20Notice%20-%20%2812-22-23%29%20Final%202.15.24%20Combined%20EN%20and%20French.pdf#page=9) . **The job details are as follows:** **Who we are** We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public benefit purpose is to provide a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs. United Therapeutics (Nasdaq: UTHR) seeks to travel down the corridors of indifference to develop treatments for rare, deadly diseases. We were founded in 1996 by a family seeking a cure for their daughter’s pulmonary arterial hypertension (PAH **)** . Today, we have six FDA-approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an organ transplant, but only a small percentage of donated organs are available to address the vast need. For this reason, we are working to create manufactured organs to address the shortage of kidneys, hearts, lungs, and livers available for transplant. We believe an unlimited supply of tolerable, transplantable organs will eliminate the transplant waiting list and cure end-stage organ diseases for which transplant is not currently an option. **Who you are** Imagine yourself as a tech-savvy, socially conscious, data driven analyst of clinical research, navigating the complex world of clinical trials with precision and expertise. As an experienced monitor, you have the unique ability to build strong relationships with site staff, ensuring that every mission is executed flawlessly. Your passion for patients and keen eye for detail make you the perfect candidate for the role of Senior Clinical Research Associate. In this role, you will be the expert in clinical monitoring activities and processes, as we move forward with our xenotransplantation clinical trials. Your mission involves both field and off-site monitoring activities, ensuring the rights and well-being of study subjects are protected, trial data is accurate, complete, and verifiable, and the study is conducted in compliance with protocols and regulations. Are you ready to fulfill your aspirations and make a difference in the world of clinical research? Join us as a Senior Clinical Research Associate - Organ Transplantation and become the hero our patients need! **For this role you will need** Minimum Requirements + Bachelor’s Degree preferably in a health, biological sciences, or related field or + Registered Nurse (RN) nursing qualifications or relevant clinical research experience in pharmaceutical/biotech/medical device or CRO industry may be considered + Experience in monitoring in-patient or complex studies, and/or therapeutic areas of transplant, end stage renal disease, chronic kidney disease, cardiovascular disease, cardiac or other implantable devices + 8+ years of relevant pharmaceutical industry experience + 5+ years of direct clinical research associate experience + Working knowledge and understanding of the clinical trial process; including ICH-GCPs, FDA regulations and familiarity with global regulatory bodies + Proficient in performing all clinical trial tasks required of a CRA + Experience in all stages of a clinical trial (start-up, maintenance, and close-out) + Experience with development of clinical monitoring plan (CMP) + Proficient with File/Document Management Platforms such as PlexGlobal, WingSpan, Veeva and Signature Software such as Adobe Acrobat and DocuSign + EDC platforms such as Medidata RAVE, Oracle InForm, Medrio, Veeva EDC + Competent end user of Microsoft Office suite (Outlook, Word, Excel, PowerPoint) + Experience with communication systems such as Microsoft Teams, WebEx, GoToMeeting + Attention to detail and accuracy of work + Good communication skills, written and verbal + Excellent interpersonal and customer service skills + Creative problem solving + Ability to work independently and as part of a cross-functional team + Effective time management and organizational skills + Ability to multi-task in a demanding and rapidly changing environment + Ability to work a flexible work week; inclusive of evenings and/or weekends Preferred Qualifications + Ability to handle high workloads, stressful situations and meet deadlines The salary for this position ranges from $126,000 to $145,000 per year. In addition, this role is eligible for the Company’s short-term and long-term incentive programs. Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities. The salary range is the range United Therapeutics Corporation in good faith believes is the range of possible compensation for this role at the time of this posting depending on the candidate’s experience, qualifications, geographic location, and other factors permitted by law. The Company may ultimately pay more or less than the posted range. This range may be modified in the future. No amount is considered to be wages or compensation until such amount is earned, vested, and determinable under the terms and conditions of the applicable policies and plans. The amount and availability of any bonus, commission, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law. **Job Location & Travel** This is a remote role, with a travel expectation of up to 75%. At United Therapeutics, our mission and vision are one. We use our enthusiasm, creativity, and persistence to innovate for the unmet medical needs of our patients and to benefit our other stakeholders. We are bold and unconventional. We have fun, we do good. \#LI-DNI Eligible employees may participate in the Company’s comprehensive benefits suite of programs, including medical / dental / vision / prescription coverage, employee wellness resources, savings plans (401k and ESPP), paid time off & paid parental leave benefits, disability benefits, and more. For additional information on Company benefits, please visit https://www.unither.com/careers/benefits-and-amenities United Therapeutics Corporation is an Equal Opportunity Employer, including veterans and individuals with disabilities. _We strive to be an organization that engages the minds, hearts, and most spirited efforts of each of our employees. Our sense of purpose transforms what we do from work into mission, occupation into vocation and achievement into success._ _We challenge our employees with innovative and revolutionary projects, offer an environment which fosters high-level job performance and provide a highly competitive total rewards package. This is what makes United Therapeutics a stimulating place to work._
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