Senior In-House CRA (Remote - Continental US)

United Therapeutics; United States; Remote; USD 102,000 - 125,000; Full time

Job summary

An innovative biotech company is seeking a Senior In-House Clinical Research Associate to support clinical trials. This remote role involves managing site activities, ensuring compliance, and performing risk-based quality monitoring. You will collaborate with cross-functional teams to analyze clinical data, identify risks, and inform monitoring strategies. Join a mission-driven organization dedicated to developing novel therapies and expanding transplantable organ availability. If you're passionate about making a difference in patients' lives, this is the opportunity for you.

Benefits

Medical Coverage

Dental Coverage

Vision Coverage

401k Savings Plan

Paid Time Off

Paid Parental Leave

Disability Benefits

Qualifications

• 5+ years in pharmaceutical/biotech or CRO industry.
• Working knowledge of ICH-GCP and FDA regulations.

Responsibilities

• Act as primary contact for remote monitoring activities.
• Analyze clinical data and site performance metrics.

Skills

Clinical Trial Process

Data Analysis

Risk Based Monitoring

Communication Skills

Education

Bachelor's Degree in Biological Sciences

Relevant Clinical Research Experience

Tools

CTMS

EDC Systems

PlexGlobal

Veeva

QlikSense

SpotFire

Job description

California, US residents click here.

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 trial data and communication. As an experienced Senior In-House Clinical Research Associate, you will serve as the primary point of contract for remote/off-site monitoring activities. You’ll work closely with cross-functional teams to ensure the success of clinical trials by managing site activities, ensuring compliance with protocols, and performing risk based quality monitoring.

The Senior In-House CRA supports the successful execution of clinical trials by collaborating with field CRAs and cross-functional project team members, all under limited supervision. This role acts as the primary point of contact for remote/off-site monitoring activities, including data review, site communication, and maintenance of essential study documents. Key responsibilities include partnering with field CRAs on site management and documentation tasks and performing Centralized and Risk-based Quality Monitoring (RBQM). This involves analyzing clinical data and site performance metrics to identify site-level risks and trends, helping inform decisions around monitoring strategies and risk mitigation.

Minimum Requirements

• Bachelor’s degree in a biological or related life sciences, nursing qualifications or relevant clinical research experience in pharmaceutical/biotech/medical device or CRO industry may be considered
• 5+ years of experience in the pharmaceutical/biotech or CRO industry
• 2+ years of experience working as an iCRA or CRA or comparable position
• Working knowledge and understanding of the clinical trial process; including ICH-GCP, FDA regulations and familiarity with global regulatory bodies
• Prior experience/use of clinical trial electronic systems including CTMS and EDC systems
• Knowledge of File Management Platforms such as PlexGlobal, WingSpan, Veeva
• Familiar with EDC platforms such as Medidata RAVE, Oracle InForm, Medrio, Veeva EDC
• Experience with Data Analytic Platforms such as QlikSense, SpotFire
• Experience with RBQM and/or Risk Based Monitoring strategies that focus on proactively managing risk

Job Location & Travel

This is a remote position located in the continental United States. This role may travel up to 20%.

The salary for this position ranges from $102,000 to $125,000 per year. (In addition, this role is eligible for the Company’s short-term and long-term incentive programs- may not apply to all roles)

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, 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.

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.