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CUTERA INC

Manager, Clinical Research

Brisbane, CA · On-site

... FDA regulations, and applicable clinical research standards. The Manager collaborates cross ... gov postings, and other regulatory reporting activities. * Analyze clinical data and prepare study ...

LUMA

FSMA Agriculture Investigator, Sr.

Boise, ID · On-site

$23.91/hr

Becoming commissioned/credentialed with a produce category by FDA is a requirement of this job and ... gov. Thank you for your interest in the Department of Agriculture!

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How much do fda gov jobs pay per hour?

As of Jun 9, 2026, the average hourly pay for fda gov in the United States is $12.66, according to ZipRecruiter salary data. Most workers in this role earn between $10.82 and $13.46 per hour, depending on experience, location, and employer.

What types of cross-functional teams do FDA government employees typically work with, and how does this collaboration impact daily responsibilities?

FDA government employees frequently collaborate with interdisciplinary teams that may include scientists, legal experts, policy analysts, and public health professionals. This cross-functional teamwork ensures that regulatory decisions are well-rounded and scientifically sound. On a daily basis, employees may participate in meetings to review data, discuss policy implications, or coordinate responses to public health concerns. The collaborative environment fosters comprehensive problem-solving and helps employees gain a broader understanding of the regulatory landscape.

What is the difference between Fda Gov vs Food Safety Specialist?

AspectFda GovFood Safety Specialist
CertificationsVaries; often includes regulatory or compliance trainingOften requires food safety certifications like ServSafe or HACCP
Work EnvironmentGovernment agencies, offices, laboratoriesFood production facilities, inspection sites, laboratories
Employer & IndustryU.S. Food and Drug Administration, government sectorFood manufacturing, retail, consulting

Fda Gov typically refers to roles within the FDA or related government agencies focusing on regulation and compliance. Food Safety Specialists work in the food industry, ensuring safety standards are met. While both roles involve food safety, Fda Gov positions are more regulatory and policy-oriented, whereas Food Safety Specialists focus on practical implementation and inspection in the industry.

What does the FDA do?

The U.S. Food and Drug Administration (FDA) is a federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices. The FDA also oversees the safety of the nation’s food supply, cosmetics, and products that emit radiation. In addition, the FDA regulates tobacco products and works to advance public health by helping speed innovations that make medical products safer and more effective.

What are the key skills and qualifications needed to thrive as an FDA Regulatory Affairs Specialist, and why are they important?

To thrive as an FDA Regulatory Affairs Specialist, you typically need a background in life sciences or related fields, along with knowledge of regulatory guidelines and compliance standards. Familiarity with submission management systems, regulatory databases, and certifications such as RAC (Regulatory Affairs Certification) are highly valuable. Strong attention to detail, analytical thinking, and effective communication skills help professionals excel when interpreting complex regulations and working with cross-functional teams. These capabilities ensure accurate, timely submissions and help organizations maintain compliance with FDA regulations, which is critical for product approvals and market access.
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Infographic showing various Fda Gov job openings in the United States as of May 2026, with employment types broken down into 79% Full Time, 18% Part Time, 1% Temporary, and 2% Contract. Highlights an 88% Physical, 1% Hybrid, and 11% Remote job distribution, with an average salary of $26,341 per year, or $12.7 per hour.
Manager, Clinical Research

Manager, Clinical Research

CUTERA INC

Brisbane, CA • On-site

Full-time

Posted 9 days ago

Job description

Position Summary:

The Manager, Clinical Research reports to the Director, Clinical Research and is responsible for leading and managing clinical research activities with participating study physicians and research sites. This role serves as the primary point of contact for the organization and execution of pre- and post-market clinical studies, ensuring studies are conducted in compliance with Good Clinical Practice (GCP), FDA regulations, and applicable clinical research standards.

The Manager collaborates cross-functionally with Clinical, Regulatory, R&D, Marketing, and external investigators to support study integrity, patient safety, and accurate data collection and documentation. This individual is responsible for study oversight from start-up through close-out, including monitoring activities, study documentation, data management, and site support.

Duties & Responsibilities:

  • Lead the development and management of clinical study documentation, including protocols, case report forms (paper and electronic), informed consent forms, subject questionnaires, clinical study reports, statistical analysis plans, and regulatory submissions.
  • Coordinate and conduct site qualification, study initiation, interim monitoring, training, and close-out visits, ensuring timely completion of accurate monitoring reports.
  • Serve as the primary liaison between study sites, investigators, clinical coordinators, and internal stakeholders.
  • Monitor clinical study data remotely and on-site with a focus on data integrity, protocol compliance, and patient safety.
  • Develop, maintain, and manage clinical databases, study tracking tools, and study metrics reporting.
  • Track study documentation and case report forms to ensure timely and accurate data flow and study execution.
  • Generate, manage, and resolve data queries in collaboration with study sites.
  • Prepare and maintain sponsor and site regulatory documentation, including Trial Master Files (TMF/eTMF) and essential study records.
  • Assist with IRB submissions, ClinicalTrials.gov postings, and other regulatory reporting activities.
  • Analyze clinical data and prepare study performance, progress, and data analysis reports.
  • Develop work instructions, study-specific procedures, and data capture guidelines to support standardized study execution.
  • Evaluate clinical research processes, systems, and technologies to improve operational efficiency and compliance.
  • Support software selection and implementation for clinical research activities as needed.
  • Train internal staff and study personnel on study procedures, photography standards, and clinical software systems.
  • Provide clinical research support to cross-functional teams including Clinical Affairs, Regulatory, R&D, and Marketing.
  • Ensure all study activities are conducted in accordance with company SOPs, FDA regulations, ICH-GCP guidelines, and other applicable regulations.
  • Other duties as needed or required.

Minimum Requirements & Qualifications:  

  • Bachelor’s degree in Life Sciences, Allied Health, or related medical/scientific field, or equivalent combination of education and experience.
  • Minimum of 5 years of clinical research experience, including 1-2 years as a Lead, Supervisor, or Manager, preferably within the medical device, dermatology, or aesthetic industry.
  • Demonstrated experience independently managing clinical studies from start-up through close-out.
  • Strong knowledge of FDA regulations, ICH-GCP guidelines, medical terminology, and clinical trial processes.
  • Experience with EDC, eTMF, and clinical data management systems preferred.
  • Experience participating in FDA Bioresearch Monitoring (BIMO) audits preferred.
  • Proficient with Microsoft Office applications including Word, Excel, and PowerPoint.
  • Strong analytical, organizational, and problem-solving skills with exceptional attention to detail.
  • Excellent verbal and written communication and interpersonal skills.
  • Ability to manage multiple priorities in a fast-paced environment.
  • Self-motivated, collaborative, and able to work independently.
  • Must be willing to work on-site at the corporate headquarters in Brisbane, CA.
  • Ability to travel up to 30% as needed.

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