The job details are as follows:
What We Do
We build on the strength of our research and development expertise and a distinctive, entrepreneurial culture that encourages diversity, innovation, creativity, sustainability, and, simply, fun. Since inception, our mission has been to find a cure for pulmonary arterial hypertension and other life-threatening diseases. Toward this goal we have successfully gained FDA approval for five medicines, we are always conducting new clinical trials, and we are working to create an unlimited supply of manufactured organs for transplantation.
We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation (PBC). Our public benefit purpose is to provide a brighter future for patients through (a) the development of novel pharmaceutical therapies; and (b) technologies that expand the availability of transplantable organs. At the same time, we seek to provide our shareholders with superior financial performance and our communities with earth-sensitive energy utilization.
Our company was founded by an entrepreneur whose daughter was diagnosed with a life-threatening condition. She sought to find treatment options and a cure for her daughter and patients like her. We are founder-led, and relentless in our pursuit of “medicines for life”. We continue to research and develop treatments for cardiovascular and pulmonary diseases, and other orphan diseases.
How you’ll contribute
The purpose of this role is to provide administrative and operational support with the set-up, execution and close-out of clinical studies. This person will participate in infrastructure development projects, supporting the department's requirements to adhere to GCP guidelines and oversight of clinical trials.
Assist the Clinical Operations team in completion of all required tasks to meet departmental and project/study goals-
Assist with the set-up of files related to a variety of clinical trials (i.e. Site Files and Trial Master Files [TMF])
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Assist in maintaining the TMF and regulatory files in accordance with GCP; perform periodic quality control checks and completeness checks of the study files for accuracy and completeness; perform final reconciliation and archiving of documents
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Assist with the preparation, handling, distribution, and filing of clinical documentation and reports
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Act as a central contact for the clinical team for designated project communications, correspondence and associated documentation
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Assist with internal/external audit preparation of files
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Coordinate ordering and tracking of trial supplies, such as case report forms (CRFs), diary cards, lab supplies and drug supplies as needed
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Assist with communication between clinical sites, CRAs and CROs as needed
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Build and/or maintain various operational metrics for clinical trials and share with management
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Attend Clinical project/study meetings as applicable and generate meeting minutes
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Execute the mailings of site required documentation and binders for study start, conduct and close out; track the relevant information as appropriate
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Perform other duties as assigned
For this role you will need
Minimum Requirements
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Bachelor’s Degree in Arts/Sciences (BA/BS)
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1+ years of relevant experience
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Develop and maintain knowledge of relevant Lung Biotechnology Inc. SOPs and Lung Biotechnology internal tracking systems
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Develop knowledge of the Clinical Research Associate role and the different types of monitoring visits performed
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Excellent written and verbal communication skills
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Proficient in using Microsoft Office software suite including Word/Excel/Outlook/PowerPoint
Preferred Qualifications
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Prior use of an eTMF, CTMS and / or EDC systems
At United Therapeutics, you’ll realize quickly that it is not an ordinary place to work! When you join our company, you will learn, grow, contribute, have fun, and be challenged... all while making a difference in the lives of our patients.
While United Therapeutics does not require vaccination for Covid-19 at this time, we strongly encourage all employees and visitors to remain up to date on vaccinations and boosters to protect one another from illness. Employees working in customer-facing roles must adhere and comply with customers’ credentialing guidelines, which may require vaccination against Covid -19, the influenza virus, and other illnesses that could be harmful to healthcare staff and patients.
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities