Clinical Trials Administrator I

at  United Therapeutics

California, US residents
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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 Clinical Trials Administrator I will provide administrative and operational support with the set-up, execution and close-out of clinical studies. This role will also participate in infrastructure development projects, supporting the department’s requirements to adhere to Good Clinical Practice (GCP) guidelines and oversight of clinical trials. This position is located in our Silver Spring, MD office 4 days/week onsite and 1 day/week work from home.

• Assist the Clinical Operations team in completing all required tasks to meet departmental and project/study goals
• Act as a contact for the clinical team for designated project communications, correspondence, and associated documentation
• Assist with the set-up, maintenance, distribution, and periodic quality control checks of clinical documentation, Site Files, and Trial Master Files (TMF) in accordance with Good Clinical Practice (GCP) guidelines and departmental processes
• Ensure accuracy and completeness of study files through regular quality control checks
• Execute the mailings of site required documentation and binders for study start, conduct, and close-out; track relevant information as appropriate
• Assist with internal and external audit preparation of files
• Maintain regulatory files and ensure compliance with GCP standards
• Coordinate the ordering and tracking of trial supplies, including study materials, diary cards, lab supplies, and drug supplies as needed
• Assist with facilitating communication between clinical sites, Clinical Research Associates (CRAs), and Clinical Research Organizations (CROs) as needed
• Maintain contact lists and create/update various clinical operations trackers
• Build and/or maintain various operational metrics for clinical trials and share with management
• Attend clinical project/study meetings as applicable and generate meeting minutes
• Complete various system user requests and maintain up-to-date records
• Perform all other duties as required

For this role you will need

Minimum Requirements

• Associate degree in a related field with 2+ years of relevant and related experience with research and/or clinical trials
• Excellent written and verbal communication skills
• Proficient in using Microsoft Office software suite, including Word/Excel/Outlook/PowerPoint
• Ability to work with multiple projects/studies
• Strong time management and organizational skills
• Attention to detail and accuracy in work
• Strong customer service orientation and professionalism
• Ability to be flexible and adjust to rapidly changing projects
• Ability to work both independently and in a team environment

Preferred Qualifications

• Bachelor’s degree in a related field with some relevant and related experience with research and/or clinical trials
• 1+ years of experience supporting clinical trials and working in a GCP environment (pharmaceutical industry, clinical research organization, or healthcare environment)
• 1+ years of experience with electronic systems, such as electronic Trial Master File (eTMF), Clinical Trial Management System (CTMS), or Electronic Data Capture (EDC)
• CCRP - Certified Clinical Research Professional
• Knowledge of ICH Good Clinical Practice (GCP) and other appropriate industry regulations
• Knowledge of the roles of the Clinical Research Associates (CRA) and the types of monitoring visits performed

The salary for this position ranges from $30.05 to $32.69 per hour. 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.
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.
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
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

• Assist the Clinical Operations team in completing all required tasks to meet departmental and project/study goals
• Act as a contact for the clinical team for designated project communications, correspondence, and associated documentation
• Assist with the set-up, maintenance, distribution, and periodic quality control checks of clinical documentation, Site Files, and Trial Master Files (TMF) in accordance with Good Clinical Practice (GCP) guidelines and departmental processes
• Ensure accuracy and completeness of study files through regular quality control checks
• Execute the mailings of site required documentation and binders for study start, conduct, and close-out; track relevant information as appropriate
• Assist with internal and external audit preparation of files
• Maintain regulatory files and ensure compliance with GCP standards
• Coordinate the ordering and tracking of trial supplies, including study materials, diary cards, lab supplies, and drug supplies as needed
• Assist with facilitating communication between clinical sites, Clinical Research Associates (CRAs), and Clinical Research Organizations (CROs) as needed
• Maintain contact lists and create/update various clinical operations trackers
• Build and/or maintain various operational metrics for clinical trials and share with management
• Attend clinical project/study meetings as applicable and generate meeting minutes
• Complete various system user requests and maintain up-to-date records
• Perform all other duties as require