United Therapeutics is a vaccinated work environment where all employees are expected to be vaccinated against COVID-19 and provide proof of vaccination. We will provide any accommodations as required by law.
The job details are as follows:
What We Do
United Therapeutics Corporation focuses on the strength of a balanced, value-creating biotechnology model. We are confident in our future thanks to our fundamental attributes, namely our commitment to quality and innovation, the power of our brands, our entrepreneurial culture and our bioinformatics leadership. We also believe that our determination to be responsible citizens - having a positive impact on patients, the environment and society - will sustain our success in the long term.
We currently have five approved products on the market and a long-term mission of providing an unlimited supply of transplantable organs for those who need them.
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, pediatric cancers and other orphan diseases.
In 2021, we became 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.
How you’ll contribute
Support all aspects and phases of clinical monitoring including, managing clinical study activities, study set-up, confirming the accuracy of the study data, clinical site and relationship management, data collection, study closeout, and ensuring appropriate systems and procedures are in place to comply with applicable regulations and guidelines, Lung Biotechnology SOPs, and study requirements.
- Implement and monitor clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines
- Assess the qualification of potential investigative sites, initiate clinical trials at investigative sites, instruct site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites
- Communicate with investigative sites and cultivate relationships with investigators and Key Opinion Leaders (KOLs) on behalf of Lung Biotechnology
- Conduct monitoring visits and complete monitoring activities and provide documents as required by SOPs and Monitoring Plans; conduct monitoring to confirm subject safety and data integrity and review monitoring visit reports for accuracy; ensure all required training is completed and documented
- Work closely with other clinical team members and adjunct teams to facilitate timely resolution of trial and/or clinical issues
- Mentor junior level Clinical Research Associates, Clinical Trial Associates and serve as a resource for new employees
- Assist team lead in the development of trial tools or documents
- Perform other duties as assigned
For this role you will need
- Bachelor’s Degree in Arts/Sciences (BA/BS) preferably in a health or biological sciences field
- 5+ years of direct onsite clinical monitoring experience (prior Clinical Research Associate experience)
- Excellent written and oral communication skills
- Ability to manage investigative sites to facilitate trial deliverables
- Ability to escalate issues appropriately
- Demonstrated understanding of the principles of IP accountability
- Ability to identify scientific misconduct at the site level
- Working knowledge of Clinical Trial Management Systems, IVRS/IWRS, and Electronic Data Capture platforms
- Strong command of regulatory and clinical practices (ICH/GCP)
- Demonstrated aptitude and knowledge in relevant therapeutic area and/or ability to learn and integrate new/different therapeutic areas
- Working knowledge of word processing, spreadsheet, and email software (MS Office suite)
- Master’s degree (MA/MS/MBA) preferably in a health or biological sciences field or
- Doctor of Pharmacy (PharmD)
- EDC - Medidata and Inform
- Prior experience monitoring all trial components - SQV, SIV, IMV and COV
- Phase I-III studies
- CTMS - BioClinica
- IVRS/IWRS - Oracle and Suvoda
- TMF - PhlexGlobal
- Pulmonary and/or Cardiovascular Therapeutic Area
- Device Trials
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.
United Therapeutics Corporation is an Equal Opportunity/Affirmative Action Employer - EOE Minorities / Females / Protected Veterans / Individuals with Disabilities