Clinical Laboratory Scientist & Lab Manager

Research & Development Institute (RDItrials.com) is a research laboratory and biobank that serves as a Contract Research Organization (CRO) supporting many of the leading In Vitro Diagnostic (IVD) companies in the industry.

RDI works with diagnostic manufacturers who need access to blood samples and clinical data to support FDA submissions and product development. Through our network of physicians, laboratories, and research partners, we help accelerate the development and validation of new diagnostic technologies.

The Clinical Laboratory Scientist will help manage the laboratory and operational components of our IVD sample collection clinical trials. This is a unique opportunity to sit at the intersection of laboratory science, clinical research, and operational execution.

The right candidate thrives working in a startup environment where priorities move quickly, team members collaborate closely, and individuals are expected to step in, solve problems, and take ownership of projects.

At RDI, this is not a narrow laboratory role. The right candidate will be willing to wear many hats, work closely with scientists and operational teams, and take on new responsibilities as the company continues to expand nationwide.

This is a long-term career opportunity with significant room for growth as RDI continues to scale.

This is an onsite position.

Key Responsibilities

Manage validation testing for new assays, instruments, and methodologies

Support sample collection initiatives by coordinating testing requirements and laboratory supplies for research specimens

Work closely with the Chief Science Officer to generate performance qualification, method comparison, and validation reports

Manage the Proficiency Testing Program for the CLIA laboratory

Oversee laboratory inventory and supplies for new and existing research projects

Troubleshoot laboratory instruments, testing methods, and procedures

Develop and document protocols, procedures, and reports

Identify and evaluate abnormal test results and respond to technical inquiries regarding methodology, specificity, and sensitivity

Communicate with clients and research partners to coordinate laboratory activities with external testing needs

Troubleshoot technical issues and ensure corrective action when testing deviates from laboratory performance standards

Supervise laboratory technicians and ensure all work is performed according to protocols, SOPs, and regulatory requirements

Ensure compliance with Quality, Safety, and regulatory standards

Maintain accurate documentation for test results, maintenance records, and quality control

Ensure laboratory instruments operate at optimal performance through preventive maintenance

Implement and monitor QA and QC procedures

Monitor trends in service requests and implement corrective actions to improve operational efficiency

Provide leadership and direction to laboratory personnel when needed, including covering supervisory responsibilities when leadership staff are unavailable

Assist with training and onboarding of laboratory staff

Support staff competency assessments and performance evaluations when required

Assist in drafting, reviewing, and updating laboratory SOPs

Review instrument maintenance logs and perform instrument calibration verification as needed

Who You Are

• Bachelor of Science or equivalent training required for California Clinical Laboratory Scientist License

• Hold a valid, current Clinical Laboratory Scientist license issued by the California Department of Health Services – required

• 4+ years of experience in a clinical laboratory environment

• Experience with specialized testing, quality control, calibration, QC evaluation, inventory control, preventative maintenance, and quality assurance

• Incredible organizational skills and attention to detail

• A strong communicator across all mediums

• Experience with Excel, Word, and Outlook  - changed from Google workspace to Outlook. However we don't call this out in any other JDs so curious if we feel there's a need to here - do they not often come with this experience? Can it be taught? 

• An expert in clinical trial and regulatory environments
• A proactive problem solver who takes initiative and looks for ways to move things forward
• Highly organized and capable of managing multiple priorities while maintaining attention to detail
• You don't outsource accountability, you own outcomes fully 
• You thrive in ambiguity and build structure where none exists
• Excited to wear many hats, step outside traditional roles, and take on new challenges as the company grows

Requirements

Skills & Requirements

Bachelor of Science or equivalent training required for California Clinical Laboratory Scientist License

Valid and current Clinical Laboratory Scientist license issued by the California Department of Health Services – required

4+ years of experience in a clinical laboratory environment

Experience with specialized testing, quality control, calibration, QC evaluation, inventory control, preventative maintenance, and quality assurance

Strong organizational skills and attention to detail

Excellent written and verbal communication skills

Experience with Excel, Word, and Google Workspace

Strong documentation skills for clinical trial and regulatory environments

Client-service mindset and ability to work with scientists, research teams, and external partners

Benefits

• Health Care Plan (Medical, Dental & Vision) Retirement Plan (401k, IRA)
• Life Insurance (Basic, Voluntary & AD&D)
• Paid Time Off (Vacation, Sick & Public Holidays)