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Clinical Study Regulatory Assistant Jobs (NOW HIRING)

... * Assist with site qualification processes and support monitoring of external clinical sites in accordance with study protocols and applicable regulations and standards (eg. 21 CFR Part 812, GLP ...

Clinical Study Specialist - (Armonk, NY, Cambridge MA or Warren, NJ) Warren, NJ, Armonk, NY or ... Compile and maintain study manuals, reference binders, and study materials, including regulatory ...

Clinical Study Coordinators

Campus, IL · On-site

$22K - $51K/mo

... Assist with participant recruitment, consent processes, documentation, logistics, adverse event ... regulatory requirements. Help facilitate participant recruitment, consent processes, and ...

Clinical Study Coordinators

Campus, IL · On-site

$22K - $51K/mo

... Assist with participant recruitment, consent processes, documentation, logistics, adverse event ... regulatory requirements. Help facilitate participant recruitment, consent processes, and ...

Experience with study and site level management of clinical trials, including but not limited ... regulations and guidelines, the clinical protocol, and data collection requirements. * Assist in ...

Clinical Study Coordinators

Campus, IL · On-site

$22K - $51K/mo

... Assist with participant recruitment, consent processes, documentation, logistics, adverse event ... regulatory requirements. Help facilitate participant recruitment, consent processes, and ...

Demonstrated comprehensive understanding of regulatory requirements, study execution, data integrity, and project management principles for clinical studies * Experience working with all levels of ...

Demonstrated comprehensive understanding of regulatory requirements, study execution, data integrity, and project management principles for clinical studies * Experience working with all levels of ...

The Regulatory Assistant is responsible for maintaining regulatory documents pertaining to the ... Inform clinical operations of new study approvals, including at initiation, amendments, and consent ...

Provides input on local regulatory approval and reimbursement status of comparator drugs used in ... Informs Global Clinical Study Manager of any issues arising on the study, evaluates impact and ...

SENIOR CLINICAL STUDY MANAGER Zentalis is a clinical oncology innovator developing a treatment ... Monitor study progress: ensuring compliance with relevant regulations and guidelines by maintaining ...

Medical, Regulatory, Biometrics, Supply, etc. Timelines, Planning and Execution * Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for ...

Medical, Regulatory, Biometrics, Supply, etc. Timelines, Planning and Execution * Leads planning and management of the assigned clinical study(ies) from feasibility through closeout activities for ...

Clinical Study Coordinators

Campus, IL · On-site

$27K - $62K/mo

Perform Clinical Research Assistant functions as needed. Learn more about the great benefits of ... Inquiries about the application of Title IX and its regulations may be referred to the Title IX ...

Showing results 41-60

Clinical Study Regulatory Assistant information

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How much do clinical study regulatory assistant jobs pay per hour?

As of Sep 13, 2026, the average hourly pay for clinical study regulatory assistant in the United States is $20.23, according to ZipRecruiter salary data. Most workers in this role earn between $16.59 and $23.32 per hour, depending on experience, location, and employer.

What is the difference between Clinical Study Regulatory Assistant vs Clinical Research Coordinator?

AspectClinical Study Regulatory AssistantClinical Research Coordinator
CredentialsTypically requires a bachelor's degree in health sciences or related field; familiarity with regulatory guidelinesUsually holds a bachelor's degree; often has experience in clinical research or healthcare
Work EnvironmentSupports regulatory documentation, submissions, and compliance in clinical trial settingsManages participant recruitment, data collection, and study logistics at clinical sites
Employer & Industry UsageUsed by pharmaceutical companies, CROs, and research institutions for regulatory tasksCommonly employed by hospitals, research centers, and academic institutions for study coordination

While both roles support clinical trials, the Clinical Study Regulatory Assistant focuses on regulatory compliance and documentation, whereas the Clinical Research Coordinator manages day-to-day study operations and participant interactions.

What cities are hiring for Clinical Study Regulatory Assistant jobs?

Cities with the most Clinical Study Regulatory Assistant job openings:

What are popular job titles related to Clinical Study Regulatory Assistant jobs?

For Clinical Study Regulatory Assistant jobs, the most frequently searched job titles are:

Clinical Study Coordinator

Austin, TX • On-site

DiaSorin
Biotechnology Research and Development • 1 - 5K employees

Full-time

Medical, Retirement

Re-posted 6 days ago


DiaSorin rating

7.7

Company rating: 7.7 out of 10

Based on 11 frontline employees who took The Breakroom Quiz


Job description

Obsessed by Science. Entrepreneurial by Nature. United by Purpose.
Diasorin is a global leader in immunodiagnostic and molecular diagnostic solutions, advancing science to improve patient outcomes worldwide. For more than 50 years, we have combined scientific rigor with an entrepreneurial mindset, operating with a strong commitment to innovation, accountability, and results to deliver trusted diagnostic solutions.
As the Diagnostics Specialist, Diasorin continuously invests in research, technology, and people. Guided by our values of operational excellence, customer focus, and teamwork, we empower teams to think boldly, act decisively, and transform ideas into meaningful impact across one of the industry's broadest specialty diagnostic portfolios.
When you join Diasorin, you are not just filling a role. You are helping build what comes next.
Why Join Diasorin
  • Build What Matters
    Take ownership, challenge the status quo, and contribute directly to solutions that improve patient care worldwide.
  • Innovate with Agility at a Global Scale
    Work in an entrepreneurial environment that enables speed, collaboration, and global impact.
  • Grow in a People-Centered Culture
    Thrive in a culture that values accountability, inclusion, and continuous development.

Job Scope
The Clinical Study Coordinator plays an integral role in supporting the conduct of analytical and clinical studies involving Luminex in vitro diagnostic devices, planning and execution of in-house clinical studies, and qualification and monitoring of external clinical sites in accordance with Clinical Affairs timeline requirements. The role also involves activities related to the logistical requirements for the execution of clinical studies in accordance with applicable global regulations and standards (e.g. 21 CFR Part 812, CLSI, ICH) that demonstrate the performance and utility of in vitro diagnostic products.
Duties and Responsibilities
  • Day-to-day "hands on" work associated with in-house clinical studies
  • Coordinate execution of site contracts and site budget preparation
  • Process invoices for payment and track project specific budgets and spending
  • Coordinate and track clinical supplies shipped and used at clinical sites
  • Collection and analysis of experimental data generated in-house and externally
  • Assist with site qualification processes and support monitoring of external clinical sites in accordance with study protocols and applicable regulations and standards (eg. 21 CFR Part 812, GLP, CLSI, ICH)
  • Develop study tools and forms (eg. Enrollment logs, Data Record Forms, Case Report Forms etc.)
  • Collaborates with sample bank to acquire and dispense clinical specimens for use at external clinical sites
  • Maintenance of study documentation and data history files
  • Maintain working knowledge of current protocols and internal SOPs.
  • Interact with other internal Luminex departments and external service providers, if required (eg. Sequencing facilities, CROs)
  • Additional Product Development & Clinical tasks, as need arises
  • Other duties as assigned

Education, Experience, and Qualifications
  • Bachelor's Degree technical subject plus at least 3 years' work experience. required or
  • Bachelor's Degree in chemistry, biology, molecular biology or a related subject, with additional post-graduate diploma or ≥ 1 year work experience preferred but not required; preferred or
  • Master's Degree technical subject plus at least 2 years' work experience; preferred
  • 1+ Years Previous work experience with clinical trials, analytical or method validation studies preferred. preferred
  • Excellent communication, organizational and time management skills
  • Proficiency with Microsoft Office software

What we offer
Diasorin offers a competitive rewards package focused on your overall well-being. We are proud to offer a comprehensive plan of health benefits, retirement and financial wellbeing, time off programs, wellbeing support and perks. Benefits may vary by role, country, region, union status, and other employment status factors. You may also be eligible to participate in an annual incentive program. An incentive award, if any, depends on various factors, including, individual and organizational performance.
Diasorin is committed to building a workplace where people feel empowered to contribute ideas, take ownership, and grow their careers. We believe diverse perspectives strengthen innovation and help us deliver meaningful impact for patients and customers worldwide.
Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by applicable law.
This posting and recruitment process are subject to applicable local laws and regulations in the country where the position is located. Additional employment disclosures, candidate rights, and employment conditions may apply based on local jurisdiction.
Individuals hired will be required to verify identity and eligibility to work and may be subject to a background check and drug screening where permitted by law. Diasorin is committed to providing reasonable accommodations for qualified individuals with disabilities during the application process. If assistance is required, please contact hr@diasorin.com.
Recruitment Fraud Notice
Diasorin never requests payment, financial information, or personal banking details from candidates at any stage of the recruitment process. Official communications from Diasorin recruiters will only come from a verified @diasorin.com email address. If you have questions about the legitimacy of a recruitment communication, please contact hr@diasorin.com for verification.
Unauthorized third-party recruiting agencies may not submit candidates for this position without prior written authorization from the Diasorin Human Resources Department.

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