Clinical Research Specialist; CRS

Clinical Research Specialist

We are seeking an experienced Clinical Research Specialist to support the planning, execution, and management of clinical studies for medical device products. This individual will work closely with cross-functional teams to ensure clinical programs are executed efficiently, meet regulatory requirements, and support overall product development objectives.

The ideal candidate will have strong clinical study management experience, preferably within the medical device industry, and experience supporting studies conducted under FDA medical device regulations. This role will partner heavily with Research & Development (R&D) and other clinical and regulatory stakeholders.

This is a remote position, with a preference for candidates located in the Pacific Time Zone or those able to consistently work Pacific Time hours.

• Assist in the design, planning, development, and execution of clinical evaluation studies for medical device products under clinical investigation.
• Support the preparation and authoring of clinical protocols, study documentation, and regulatory submissions.
• Manage operational aspects of clinical studies in collaboration with the broader Study Team.
• Ensure clinical trial activities are conducted in accordance with Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), FDA requirements, and applicable country regulations.
• Support studies conducted under FDA 21 CFR Part 812 and other applicable medical device clinical investigation requirements.
• Partner closely with R&D throughout study planning and execution.
• Coordinate and collaborate with site managers, clinical monitors, statisticians, field teams, regulatory partners, and other cross-functional stakeholders.
• Support the selection, management, and ongoing oversight of clinical sites and external vendors.
• Monitor study progress, timelines, deliverables, and potential risks to ensure successful study execution.
• Assist with clinical study budgets and resource planning as needed.
• Review and interpret clinical investigation results to support new or expanded medical device applications.
• Build and maintain effective working relationships with internal teams, clinical sites, vendors, and other external partners.
• Support evidence-generation and dissemination activities related to clinical research programs.

• Demonstrated experience supporting or managing clinical research studies or clinical trials.
• Strong knowledge of clinical trial operations and clinical study management.
• Understanding of Good Clinical Practice (GCP) and FDA regulatory requirements.
• Experience working with FDA 21 CFR Part 812 or medical device clinical investigations is highly desirable.
• Experience with in the medical device industry is strongly preferred.
• Ability to work effectively with cross-functional teams, particularly R&D, Regulatory, Clinical Operations, and Biostatistics.
• Experience managing clinical sites, vendors, study timelines, and operational deliverables.
• Strong project management, organizational, communication, and problem-solving skills.
• Ability to work independently in a remote environment while maintaining strong cross-functional collaboration.
• Ability to work Pacific Time Zone hours.

• Previous experience functioning as a Clinical Study Manager, Clinical Trial Manager, Clinical Project Manager, Clinical Research Specialist, or similar clinical operations professional.
• Medical device clinical research experience.
• Experience supporting clinical programs within diabetes, diabetes therapies, or diabetes-related medical devices is a strong plus.
• Experience working on clinical programs with significant R&D collaboration.
• Experience authoring or contributing to protocols and regulatory submissions.

Job Type &

Location:

This is a Contract position based out of Los Angeles, CA.

Pay and Benefits:

The pay range for this position is $40.00 - $60.00/hr individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms.

If eligible, the benefits available for this temporary role may include the following:
Medical, dental & vision Critical Illness,…