Clinical Research Specialist (CRS)

Actalent; United States; Remote; USD 55,000 - 83,000; Full time

Job summary

Actalent is seeking a Clinical Research Specialist for a fully remote role focused on planning, execution, and management of clinical studies for medical devices. You will partner with R&D, Regulatory, and Clinical Operations to ensure regulatory compliance and timely delivery, while aligning with PT hours for the Pacific Time Zone.

This contract role supports global programs and vendor oversight. The position emphasizes study design, protocol authoring, site management, and budget oversight,

Qualifications

• Experience supporting or managing clinical research studies.
• Knowledge of GCP and FDA regulatory requirements.
• Experience with medical device clinical investigations is desirable.
• Ability to work remotely with cross-functional teams.
• Experience coordinating sites and vendors.

Responsibilities

• Assist in design, planning, development, and execution of clinical evaluation studies for medical device products.
• Support 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 activities conform to SOPs, GCP, FDA requirements, and country regulations.
• Support FDA 21 CFR Part 812 and other medical device clinical investigation requirements.

Skills

Clinical study management

FDA regulatory requirements

Cross-functional collaboration

Remote work

Project management

Job description

Clinical Research Specialist

Position Overview

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.

Key Responsibilities

• 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.

Qualifications

• 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 within 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.

Preferred Experience

• 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 Title: Clinical Research Specialist

Work Environment: Remote

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 jobclassification and length of employment. Benefits are subject to change and may besubject to specific elections, plan, or program terms. If eligible, the benefitsavailable for this temporary role may include the following:Medical, dental & visionCritical Illness, Accident, and Hospital401(k) Retirement Plan Pre-tax and Roth post-tax contributions availableLife Insurance (Voluntary Life & AD&D for the employee and dependents)Short and long-term disabilityHealth Spending Account (HSA)Transportation benefitsEmployee Assistance ProgramTime Off/Leave (PTO, Vacation or Sick Leave)

Workplace Type

This is a fully remote position.

Application Deadline

This position is anticipated to close on Oct 3, 2026.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications withoutregard to race, sex, age, color, religion, national origin, veteran status, disability,sexual orientation, gender identity, genetic information or any characteristic protectedby law.

San Francisco Fair Chance Ordinance:Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in thecity and county of San Francisco, we will consider for employment qualified applicantswith arrest and conviction records.

Massachusetts Lie Detector:It is unlawful in Massachusetts to require or administer a lie detector test as acondition of employment or continued employment. An employer who violates this lawshall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI):We may use Artificial Intelligence (AI) to support parts of our hiring process,including sourcing, screening, and evaluating candidates. AI helps assess applicationsand qualifications, but final decisions are made by our hiring team. By applying, youacknowledge and agree that your application may be reviewed using AI tools.