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Senior Clinical Research Associate

3+ years
$110K-$130K / yr.
10 March 3, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Senior Clinical Research Associate

Location: Brisbane, CA
Salary Range: $110K - $130K per year
Employment Type: Full-time

Company Overview:

Cutera, Inc. is a leading aesthetic device company with a strong global presence, offering innovative laser and radio frequency technologies. Cutera’s clinical team is dedicated to advancing medical aesthetic technologies through science-driven research.

Position Summary:

The Senior Clinical Research Associate (SCRA) will oversee pre- and post-market clinical research studies, ensuring regulatory compliance, study integrity, and accurate data documentation. This role involves coordinating with investigators, site coordinators, and regulatory personnel, acting as the primary contact for study sites. The SCRA will also support clinical study execution, data tracking, site monitoring, and regulatory submissions.

Key Responsibilities:

  • Develop and manage clinical study documents, including protocols, case report forms, informed consent forms, and clinical study reports.
  • Conduct site qualification, study initiation, monitoring, and close-out visits, ensuring compliance with regulatory requirements.
  • Track and manage study and data flow, ensuring the timely submission of reports.
  • Monitor clinical data integrity and patient safety through remote and on-site reviews.
  • Manage essential regulatory documents in electronic or physical Trial Master Files (eTMF).
  • Generate data queries and collaborate with study sites to resolve discrepancies.
  • Ensure compliance with FDA regulations, ICH-GCP guidelines, and Cutera SOPs.
  • Analyze clinical data using statistical tools and support regulatory submissions.
  • Train staff on study procedures, software usage, and data collection methods.
  • Participate in FDA audits and ensure site readiness.
  • Assist in selecting software tools for clinical research and data management.
  • Collaborate with cross-functional teams in clinical affairs, regulatory, R&D, and marketing.

Qualifications:

  • B.Sc. in life sciences, allied health, or related field.
  • 3+ years of experience in a clinical research environment.
  • Proven experience leading clinical studies from startup to closeout.
  • Medical device, dermatology, or aesthetics experience preferred.
  • Strong understanding of GCP guidelines, clinical trial processes, and FDA regulations.
  • Proficiency in Microsoft Office, EDC, eTMF, and data management systems.
  • Experience with FDA bioresearch monitoring (BIMO) audits preferred.
  • Strong communication, problem-solving, and organizational skills.
  • Ability to work in a fast-paced environment, prioritize tasks, and multitask efficiently.
  • Willingness to work on-site (Monday-Friday) in Brisbane, CA.
  • Ability to travel up to 30% as required.

Compensation & Benefits:

  • Base Salary: $110,000 - $130,000 per year
  • Stock Options & Employee Stock Purchase Plan (ESPP)
  • Comprehensive Benefits Package

Cutera is an equal opportunity employer committed to fostering a diverse and inclusive workplace.