- Location
- Van Nuys, California, United States · published
- Workplace
- Onsite
- Type
- Part-time
- Department
- Healthcare
- Seniority
- Director
- Source
- Workable
Description
RDI Trials | Van Nuys, California
Part-time or fractional, with regular onsite involvement
RDI is a clinical research organization focused exclusively on in vitro diagnostics. We help diagnostic manufacturers execute studies through our physician network, clinical sites, and in-house CLIA-certified, CAP-accredited laboratory.
We have completed more than 300 trials. Our work spans clinical chemistry, mass spectrometry, molecular diagnostics, infectious disease, and other diagnostic applications.
We are seeking a physician to serve as our laboratory director, take responsibility for assigned studies as Principal Investigator, and work directly with sponsors and participating physicians.
The role
You will work alongside our CEO, COO, laboratory staff, and clinical operations team. Your first priorities will be assuming laboratory directorship and learning the active studies so that you can take responsibility for their medical and scientific oversight.
Our current portfolio includes complex mass-spectrometry stability studies involving multiple specimen types, collection conditions, and testing time points. Other programs involve prospective specimen collection, diagnostic performance evaluation, and assay validation.
You will need to understand how the work is performed, make informed decisions, and follow issues through to resolution.
Responsibilities
Direct the laboratory
- Serve as the laboratory director of record and fulfill the responsibilities of the appointment.
- Oversee laboratory quality, proficiency testing, personnel competency, method verification and validation, and corrective actions.
- Maintain inspection readiness and oversee responses to CAP, CLIA, and California laboratory regulatory matters.
- Assess requirements for the current test menu and proposed additions.
- Work directly with laboratory staff to resolve scientific, quality, and testing issues.
Lead assigned studies as Principal Investigator
- Understand the protocol, laboratory workflow, study records, and delegated responsibilities.
- Provide active oversight of study conduct, data, deviations, unresolved questions, and required approvals.
- Participate in sponsor meetings, monitoring visits, protocol training, and closeout.
- Identify execution risks and make clear recommendations to resolve them.
Apply medical judgment to study design
- Review eligibility criteria, specimen requirements, collection timing, and testing plans.
- Assess whether proposed procedures fit clinical practice and can be executed at participating sites.
- Resolve medical and scientific questions with sponsors, investigators, and specialist advisors.
- Help translate client requirements into practical protocols and work instructions.
Engage physicians and clients
- Conduct physician outreach and explain study requirements.
- Assess site feasibility through substantive discussions with investigators.
- Help secure physician participation and resolve questions during startup and enrollment.
- Join selected client calls to assess requirements and explain RDI's approach.
- Identify assumptions that affect study feasibility, scope, timeline, and cost.