Senior Clinical Research Associate - California - Cardio Medical Device

ICON; California (MO); Hybrid; USD 110,000 - 132,000; Full time

Job summary

Join a leading clinical research organization as a Senior Clinical Research Associate (Sr CRA) in California. This role offers the opportunity to support cardiovascular/electrophysiology medical device trials, ensuring adherence to regulatory standards and driving study compliance. You'll engage with trial sites, mentor less experienced staff, and contribute to process improvements while enjoying a competitive salary and comprehensive benefits. If you're passionate about advancing healthcare through clinical research, this position is an exciting opportunity to make a significant impact in the field.

Benefits

Health Insurance

Retirement Plans

Employee Assistance Program

Flexible Benefits

Life Assurance

Qualifications

• 5+ years of monitoring experience in clinical trials.
• Knowledge of GCP and ICH guidelines is essential.

Responsibilities

• Ensure compliance with SOPs and local regulations.
• Act as primary contact for trial sites and investigators.
• Drive study compliance during all phases of the trial.

Skills

Monitoring Experience

Communication Skills

Collaboration Skills

Knowledge of GCP

Knowledge of ICH Guidelines

System Proficiency

Education

Bachelor's Degree in Life Sciences

Bachelor's Degree in Physical Sciences

Bachelor's Degree in Nursing

Bachelor's Degree in Biological Sciences

Job description

As a Sr CRA, you will join the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence.

What will you be doing?

You will support 1 protocol in the cardiovascular/electrophysiology medical device space.

Key Responsibilities include:

• Ensuring services adhere to applicable SOPs, WIs, policies, and local regulatory requirements.
• Contributing to site selection through feasibility and pre-trial assessments, collaborating with the trial team.
• Acting as the primary contact for trial sites, engaging with investigators and site staff throughout the trial.
• Driving study compliance during initiation, monitoring, management, and close-out phases.
• Training site staff and maintaining accurate training records.
• Supporting recruitment strategies and contingency planning at the site level.
• Ensuring sites are equipped with necessary supplies and maintaining inventory records.
• Ensuring quality and completeness of data, resolving queries timely.
• Reporting and documenting adverse events and ensuring inspection readiness.
• Engaging with investigators through timely communication and follow-up.
• Collaborating with the trial team to document progress and issues.
• Maintaining inspection readiness and therapeutic knowledge.
• Ensuring CAPA completion for QA audits and site issues.
• Negotiating investigator budgets and tracking costs, if applicable.
• Participating in regulatory submissions as needed.
• Mentoring less experienced staff and contributing to process improvements.
• Reporting time accurately and promptly.

Preferred Qualifications:

• Bachelor's degree in Life Sciences, Physical Sciences, Nursing, or Biological Sciences.
• At least 5 years of monitoring experience.
• Location in California preferred.
• Experience in electrophysiology or cardiac medical devices is preferred, but strong cardiology pharma experience is also acceptable.
• Strong communication, collaboration, and system proficiency skills.
• Knowledge of GCP, ICH guidelines, and local regulations.
• Ability to travel up to 65%.
• Legal authorization to work in the US without sponsorship.

Pay Range: $110,520 - $131,150 USD. Compensation depends on experience, location, and skills.

What ICON offers:

• Competitive salary and benefits focused on well-being and work-life balance.
• Benefits include leave entitlements, health insurance, retirement plans, Employee Assistance Program, life assurance, and flexible benefits.
• Visit https://careers.iconplc.com/benefits for more information.

ICON values inclusion and diversity. We are committed to providing an accessible environment and equal employment opportunities. For accommodations, please contact us through the provided link.

Interested but unsure if you meet all requirements? We encourage you to apply—your background might be a perfect fit for this or other roles at ICON.