Senior CRA - Cardio Trials (65% Travel)

Regulatory Toolkit; United States; À distance; USD 111 000 - 138 000; Plein temps

Avantages offerts par ce poste

Competitive base salary

Health and wellbeing programs

Retirement and pension plans

Learning and development opportunities

Résumé du poste

ICON Strategic Solutions seeks a Senior Clinical Research Associate for Cardio (Smartpulse A-fib) to monitor cardiovascular medical device trials and support regulatory compliance. Based in the US West region, candidates should be able to travel up to 65% and collaborate with sites, investigators, and internal teams.

The role requires a bachelor’s degree and at least 3 years of monitoring experience, with preference for life science backgrounds.

Qualifications

• In-depth knowledge of FDA regulations and ICH/GCP guidelines.
• Strong problem-solving skills to mitigate risks and identify issues at sites and implement effective solutions promptly.
• Strong interpersonal skills to establish and maintain effective working relationships with site personnel, investigators, and internal teams.
• Exceptional verbal and written communication skills, with the ability to convey complex information clearly and concisely.
• Ability to tailor communication style to the needs and preferences of different stakeholders, fostering a collaborative environment.
• Ability to work independently and manage multiple priorities in a dynamic environment.
• Well-versed in clinical trial management with rigorous, detailed reporting.

Responsabilités

• Monitor cardiovascular medical device trials in the sponsor-dedicated model.
• Coordinate with sites, investigators, and internal teams to ensure trial progress.
• Ensure regulatory compliance with FDA/ICH guidelines.
• Communicate study updates clearly to all stakeholders and teams.
• Travel coverage up to 65% across the West region of the US.

Connaissances

FDA regulations

ICH/GCP guidelines

problem solving

interpersonal skills

communication skills

stakeholder communication

independence

multitasking

trial management

Formation

Bachelor’s degree

Description du poste

ICON Strategic Solutions seeks a Senior Clinical Research Associate for Cardio (Smartpulse A-fib) to monitor cardiovascular medical device trials and support regulatory compliance. Based in the US West region, candidates should be able to travel up to 65% and collaborate with sites, investigators, and internal teams.

The role requires a bachelor’s degree and at least 3 years of monitoring experience, with preference for life science backgrounds.