Clinical Monitoring Standards Lead

RDI

$100K — $130K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • 5+ years of clinical research experience with a focus on IVD CRAs
  • Deep understanding of regulatory requirements and monitoring standards
  • Proven history of maintaining high-quality audit readiness during clinical trials
  • Experience building or operating systems for multiple studies
  • Ability to mentor and lead both junior CRAs and data-entry staff
  • Expertise in modernizing clinical trial monitoring methodologies
  • Strong attention to detail and accountability in quality assurance

Responsibilities

  • Lead the monitoring quality and audit-readiness for diagnostic studies
  • Develop and manage systems that showcase study quality to stakeholders
  • Modernize trial oversight using risk-based and AI-assisted workflows
  • Mentor junior CRAs while directly engaging in detailed quality work
  • Conduct thorough inspections of informed consent and data sources
  • Keep multiple studies inspection-ready while holding the team accountable
  • Interact closely with the operations team to ensure standards are upheld

Benefits

  • Collaboration in a passionate and caring team environment
  • Merit-based structure with opportunities for direct involvement
  • Management-led recruiting process ensuring strong applicant engagement
  • Flexibility for remote work given proven experience in quality management
  • Access to innovative practices in clinical trial monitoring
Full Job Description
The Role

Can you build a world-class team of IVD CRAs?

We have a passionate, caring, hard-working clinical operations team that wants to perfect its craft. We are looking for someone who can raise the standard across the team and make sure that standard holds across every study.

You will own monitoring quality and audit-readiness across RDI's diagnostic studies. You will develop the systems that demonstrate study quality and status to leadership and, where appropriate, to clients.

You will also help modernize clinical trial monitoring as the industry moves toward risk-based monitoring, real-time oversight, remote-first execution, and AI-assisted workflows without compromising quality.

You need real knowledge of the regulations and monitoring standards. If your understanding comes mainly from checklists, templates, or PowerPoints someone else made for you, this is not the right role.

This role is for a master of the craft: someone who can do the work, teach the work, inspect the work, and hold a team to the standard.
The Work

You will own audit-readiness across RDI's diagnostic studies and help lead a team of junior CRAs and data-entry team members.

The ideal candidate already knows what that means and has likely built or operated a system that keeps multiple studies inspection-ready at once.

This is not traditional management. RDI is a small, merit-based company, and no leader here gets to stay above the work.

You will dig into the details: reviewing an individual informed consent, checking source against CRF data, walking through query status, reviewing a binder, or finalizing a monitoring report alongside the team.

You are accountable for the standard holding in real work, not just existing in a document.
Location and Schedule

This role is strongest if based near our Los Angeles / Van Nuys office.

Remote candidates will be considered only if they have a proven method for learning our business, applying our standards, and managing quality across a remote team.
About Our Process

Our recruiting process is management-led. If your application and background fit, either the CEO or COO will reach out directly for a phone screen.

Given the volume of applicants, we cannot reply to everyone, but we reply to every strong application.

Similar Jobs

More Jobs at RDI

More Pharmaceuticals & Biotech Jobs

Find similar Clinical Monitoring Standards Lead jobs: