Clinical Research Associate-Cardio

ICON Strategic Solutions; California; On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

Employee Assistance Program

Life assurance

Flexible benefits

Job summary

ICON is seeking an experienced regional Clinical Research Associate (CRA) based in California to monitor cardiovascular device studies within a sponsor team. You’ll act as the primary site contact, conduct visits, ensure regulatory compliance, and maintain CTMS/eTMF documentation while supporting recruitment and safety reporting.

The ideal candidate has 3+ years of on-site monitoring in pharma or CRO, with cardiovascular device experience preferred.

Qualifications

• Requires 3+ years of on-site monitoring experience in pharma or CRO
• Cardiovascular medical device monitoring experience preferred
• Knowledge of ICH-GCP and regulatory requirements essential

Responsibilities

• Serve as the primary site sponsor contact and monitor study progress
• Conduct site visits including selection, initiation, routine monitoring and close-out
• Ensure site compliance with ICH-GCP, SOPs and health regulations
• Maintain documentation in CTMS and eTMF
• Monitor patient safety and adverse event reporting
• Support site patient recruitment and retention at the site level
• Collaborate with cross-functional teams across CTAs, LTMs, and CTMs

Skills

On-site monitoring

Cardiovascular device knowledge

ICH-GCP

CTMS

eTMF

Education

Bachelor’s degree in Life Sciences or equivalent

RN license

Tools

CTMS

eTMF

Job description

Great opportunity for an experienced regional CRA to expand into the cardio medical device by joining one of ICON's large exciting sponsor teams

What You’ll Be Doing:

• Support study in the cardiovascular/electrophysiology medical A-fib device space.
• Serve as the primary point of contact between investigational sites and the sponsor
• Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out
• Ensure site compliance with ICH-GCP, SOPs, and Health regulations
• Maintain up-to-date documentation in CTMS and eTMF systems
• Support and track site staff training and maintain compliance records
• Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting
• Support subject recruitment and retention efforts at the site level
• Resolve data queries and drive timely, high-quality data entry
• Document site progress and elevate risks or issues to the clinical team
• Assist in tracking site budgets and ensuring timely site payments (as applicable)
• Collaborate with cross-functional partners including CTAs, LTMs, and CTMs

You are:

• Based in California or nearby PST/MST state
• Eligible to work in the US without visa sponsorship
• A clinical research professional with 3 + years of on-site monitoring experience in the pharmaceutical or CRO industry
• The ideal candidate will have cardiovascular medical device monitoring experience- however, complex experience in cardiovascular/electrophysiology pharma monitoring and/or Coordinator/Nursing experience will be considered.
• Experienced in oncology or hematology studies
• A graduate with a Bachelor’s degree in Life Sciences or equivalent, or a qualified RN
• Knowledgeable in Health Canada regulations and working with Research Ethics Boards (REBs)
• Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF
• A clear communicator, problem-solver, and collaborative team player

What ICON can offer you:

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

• Various annual leave entitlements
• A range of health insurance offerings to suit you and your family’s needs
• Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead
• Global Employee Assistance Program TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialized professionals who are there to support you and your family’s well-being
• Life assurance
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidized travel passes, health assessments, among others

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.