Senior In-House CRA (Remote - Continental US)

United Therapeutics Corporation; Daly City (CA); Remote; USD 102,000 - 125,000; Full time

Job summary

An innovative pharmaceutical company is seeking a Senior In-House CRA to lead remote monitoring activities and ensure compliance in clinical trials. This role offers the opportunity to work closely with cross-functional teams, utilizing your expertise in clinical trial processes and data analysis to drive trial success. You will play a crucial role in identifying risks and implementing monitoring strategies while enjoying the flexibility of a remote position with minimal travel. Join a forward-thinking organization dedicated to developing groundbreaking therapies and making a difference in patients' lives.

Benefits

Medical benefits

Dental benefits

Vision benefits

401k

Paid time off

Qualifications

• 5+ years of experience in the pharma/biotech industry.
• 2+ years working as an iCRA or CRA.
• Knowledge of clinical trial processes and regulations.

Responsibilities

• Serve as the primary contact for remote monitoring activities.
• Collaborate with field CRAs and project teams.
• Perform risk-based quality monitoring and data analysis.

Skills

Clinical trial processes

ICH-GCP knowledge

FDA regulations

Data analytics

Risk-based monitoring strategies

Clinical trial electronic systems (CTMS, EDC)

Education

Bachelor’s degree in biological sciences

Relevant clinical research experience

Tools

PlexGlobal

WingSpan

Veeva

Medidata RAVE

Oracle InForm

Medrio

QlikSense

SpotFire

Job description

Senior In-House CRA (Remote - Continental US)

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Job Details

Who We Are

We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our purpose is to provide a brighter future for patients through developing novel pharmaceutical therapies and technologies that expand the availability of transplantable organs.

United Therapeutics (Nasdaq: UTHR) aims to develop treatments for rare, deadly diseases. Founded in 1996, we have six FDA-approved therapies for PAH, PH-ILD, and neuroblastoma. Our pipeline includes therapies for PAH and pulmonary fibrosis (PF). We are also working to create manufactured organs to address the organ shortage, aiming to eliminate transplant waiting lists and cure end-stage organ diseases.

Who You Are

You are a tech-savvy, socially conscious, data-driven clinical research analyst. As a Senior In-House CRA, you will serve as the primary contact for remote monitoring activities, working closely with cross-functional teams to ensure trial success through site management, compliance, and risk-based quality monitoring.

You will collaborate with field CRAs and project teams, support site management, and perform centralized and risk-based quality monitoring by analyzing clinical data and site performance metrics to identify risks and inform monitoring strategies.

Minimum Requirements

• Bachelor’s degree in biological or related sciences, nursing, or relevant clinical research experience in pharma/biotech/medical device or CRO industry
• 5+ years of experience in the industry
• 2+ years working as an iCRA, CRA, or similar role
• Knowledge of clinical trial processes, ICH-GCP, FDA regulations, and global regulatory bodies
• Experience with clinical trial electronic systems (CTMS, EDC)
• Knowledge of file management platforms (PlexGlobal, WingSpan, Veeva)
• Familiarity with EDC platforms (Medidata RAVE, Oracle InForm, Medrio, Veeva EDC)
• Experience with data analytic platforms (QlikSense, SpotFire)
• Experience with RBQM and risk-based monitoring strategies

Job Location & Travel

This is a remote position within the continental US, with up to 20% travel.

The salary range is $102,000 to $125,000 annually, plus potential incentives. Compensation may vary based on experience, location, and other factors. Benefits include medical, dental, vision, 401k, paid time off, and more. For details, visit our benefits page.

United Therapeutics is an Equal Opportunity Employer.

Additional Details

• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Research, Analyst, IT
• Industry: Pharmaceutical Manufacturing