Senior Clinical Research Associate Job at TRICARDIA, Fremont, CA

WkdLWTRMVGs2U2w2dldVZWlOL3gxc0EzTlE9PQ==
  • TRICARDIA
  • Fremont, CA

Job Description

Senior Clinical Research Associate (Medical Device Focus)

Location: Remote (Bay Area preferred)

Employment Type: Full-Time

Salary Range: $122,000–$166,000 + Bonus and Equity

Are you an experienced Clinical Research Associate with a passion for advancing innovation in medical technology? We’re looking for a Senior CRA to take ownership of site monitoring and clinical operations across a portfolio of high-impact medical device trials.

About the Role

You will independently manage all aspects of site monitoring—from qualification through close-out. You'll be the main point of contact for investigative sites, ensuring compliance with regulatory guidelines, supporting clinical trial execution, and maintaining an audit-ready environment.

This role is a great fit for someone with a strong understanding of FDA, ICH-GCP, and ISO 14155, and hands-on experience in medical device clinical trials.

Key Responsibilities

  • Conduct site qualification, initiation, monitoring, and close-out visits
  • Ensure proper source data verification, informed consent, and investigational product accountability
  • Maintain strong site relationships and resolve issues proactively
  • Draft monitoring visit reports and maintain trial documentation in the TMF
  • Collaborate with cross-functional teams including Regulatory, Data Management, Quality, and Project Management
  • Support protocol and CRF development, and participate in audits or inspections
  • Mentor junior CRAs or CTAs as needed

Qualifications

  • Minimum 5 years of clinical research experience with independent site monitoring
  • In-depth knowledge of FDA regulations, ICH-GCP, and ISO 14155
  • Experience in medical device trials strongly preferred
  • Proficiency with CTMS, EDC, and eTMF systems
  • Bachelor’s degree in Life Sciences, Nursing, or a related field (advanced degree or certification preferred)
  • Willingness to travel up to 35% for site visits

Why Apply

  • Remote flexibility, with preference for candidates based in the Bay Area
  • Competitive compensation aligned with Bay Area market data
  • Bonus, equity, and comprehensive benefits
  • Collaborative, high-growth environment with real impact on patient outcomes

Job Tags

Full time, Remote job,

Similar Jobs

Tekton

Manufacturing Operator Job at Tekton

About the company Tekton, Inc. is a family-owned company in Grand Rapids, Michigan. We are dedicated to making the best hand tools you will ever own, and we start by designing the products that we personally believe in and want to own ourselves. We focus especially on...

Roman and Williams Buildings and Interiors

Senior Operations Manager Job at Roman and Williams Buildings and Interiors

 ...Job Summary: We are seeking a highly organized and proactive Senior Operations Manager with luxury home retail experience to oversee the day-to-day operations of our luxury retail store. This role requires a dynamic individual who is strong leader, a problem solver,... 

Meadowbrook Inn

Banquet Server Job at Meadowbrook Inn

 ...Job Summary: The Banquet Server position sets up for an event, provides exceptional customer service throughout the entire event, and...  ...require work on weekends, nights and holidays. Please, no phone calls about this job! EOE/AA. We provide equal opportunity without... 

Essentia Health

Pharmacy Technician- Mail Order Pharmacy/Call Center (80 hours per pay period) Job at Essentia Health

Job Description: Is responsible for the accurate computer entry and processing of prescriptions, preparing unit dose medications, and non-sterile bulk compounding. Job duties also include inventory control, care of supplies and equipment, accurate cash handling, customer...

National Trust for Historic Preservation

Chief Development Officer (Filoli) Job at National Trust for Historic Preservation

Work at the National Trust for Historic PreservationDepartment: Historic SitesLocation: Woodside, CAPosition SummaryThe Chief Development Officer (CDO) will be responsible for planning, implementing, overseeing, and assessing Filolis comprehensive development strategies...