Senior Clinical Research Associate (CRA) – Class III Cardiac Medical Device

Magenta Medical Ltd.; United States; Remote; USD 65,000 - 75,000; Full time

Job summary

A leading medical device company is seeking a Senior Clinical Research Associate to oversee clinical trial sites and ensure compliance. This remote role within the United States involves managing site operations and mentoring junior staff, while contributing to innovative cardiac medical devices.

Benefits

Medical insurance

Qualifications

• 5+ years of clinical research experience, focusing on on-site management.
• Experience with Class 3 medical devices and/or complex clinical trials.

Responsibilities

• Serve as the primary liaison between trial sites and sponsor teams.
• Oversee site management, including regulatory submissions and training.

Skills

Communication

Problem-Solving

Organizational Skills

Education

Bachelor’s degree in Life Sciences

MD, MBA, or advanced degrees

Tools

CTMS

eTMF

Job description

Senior Clinical Research Associate (CRA) – Class III Cardiac Medical Device

Join to apply for the Senior Clinical Research Associate (CRA) – Class III Cardiac Medical Device role at Magenta Medical Ltd.

Senior Clinical Research Associate (CRA) – Class III Cardiac Medical Device

Join to apply for the Senior Clinical Research Associate (CRA) – Class III Cardiac Medical Device role at Magenta Medical Ltd.

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About the Company - Magenta is a medical device company developing the world’s smallest heart pump, meant to provide minimally-invasive support to the heart during acute episodes of dysfunction. The Elevate System is multi-disciplinary, involving mechanical engineering, material science, electrical engineering, software, algorithms and state-of-the-art catheter fabrication techniques. We are looking for the best people possible who can help us propel the Elevate System forward and save more lives.

About the Role - We are seeking an experienced Senior Clinical Research Associate (Sr. CRA) to oversee clinical trial sites, ensure regulatory compliance, and support site operations.

Reports to: Director, Clinical Trial Management.

***The position is remote, but only within the United States.

Responsibilities

• Serve as the primary liaison between trial sites and sponsor teams, resolving site-related issues.
• Oversee site management, including regulatory submissions, training, and study conduct.
• Maintain clinical trial documentation in eTMF and CTMS systems. Ensure site compliance with protocols, regulations, and GCP guidelines.
• Support remote monitoring by reviewing site documentation and resolving queries.
• Assist in audits and regulatory inspections, ensuring audit readiness.
• Track and follow up on SAEs, protocol deviations, and safety reporting.
• Provide site staff training on protocol, GCP compliance, and data entry.
• Collaborate with cross-functional teams to ensure smooth study execution.
• Assist in investigator payments, site invoicing, and budget adherence.
• Mentor junior CRAs and study coordinators.

Qualifications:

• Bachelor’s degree in Life Sciences or related field (MD, MBA, or advanced degrees preferred) – must.
• 5+ years of clinical research experience, focusing on on-site management and clinical trial support- must.
• Experience with Class 3 medical devices and/or complex clinical trials.
• Strong knowledge of FDA, ICH-GCP, and global regulations. Proficiency in CTMS and eTMF systems.
• Excellent communication, problem-solving, and organizational skills.

Preferred Skills

• Clinical Research Associate certification (CCRA)
• Experience with regulatory submissions and audits
• Knowledge of risk-based monitoring and site engagement strategies.
• Strong organizational and multitasking abilities.
• Excellent communication skills, both written and verbal.
• Meticulous attention to detail.
• Proactive problem-solving and adaptability in a fast-paced environment.
• Team-oriented mindset and willingness to collaborate.

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Science

• Industries

  Medical Device

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Medical insurance

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