Job Description

Job Description

Job Description

About Us

Hyperfine, Inc. (Nasdaq: HYPR) is the groundbreaking health technology company that has redefined brain imaging with the Swoop® system—the first FDA-cleared, portable, ultra-low-field, magnetic resonance brain imaging system capable of providing imaging at multiple points of care in a healthcare facility. Our mission is to revolutionize patient care globally through transformational, accessible, clinically relevant diagnostic imaging. Learn More

About The Role

Job Title: Senior Clinical Research Associate

Location: Palo Alto, CA

As our Senior Clinical Research Associate (Senior CRA), you will play a crucial role in the planning, coordination, and execution of clinical studies, with a particular emphasis on post-market evidence generation. Your experience in neuroscience, MRI technology, and medical devices will be pivotal in ensuring the quality and compliance of our clinical trials. You will work closely with cross-functional teams to support clinical research activities, contributing to the success of our innovative imaging solutions.

Key Responsibilities:

• Oversee and monitor multi-center clinical trials to ensure adherence to study protocols, Good Clinical Practice (GCP), and regulatory requirements.
• Conduct pre-study, initiation, monitoring, and close-out visits to clinical sites.
• Collaborate with site investigators, site coordinators, and other stakeholders to support recruitment, training, and study execution.
• Support the whole life cycle of study development, including protocol design, IRB submission, study start-up activities, monitoring, data cleaning, and study close-out.
• Review and manage study data, ensuring data quality and accuracy.
• Develop and maintain study documentation, including monitoring visit reports and compliance documentation.
• Support post-market evidence generation by collecting and analyzing clinical data to validate the device's effectiveness and safety.
• Assist in the development and implementation of study protocols, standard operating procedures (SOPs), and work instructions (WIs).
• Ensure timely resolution of site and study issues, escalating them when necessary.
• Maintain strong, collaborative relationships with internal and external teams to enhance study performance.

Education/Experience Required:

• Bachelors degree in Biomedical or Neuroscience Sciences or related field
• Minimum 8 years of experience as a CRA or in clinical monitoring within the medical device or pharma industry.
• Strong background in clinical monitoring, with experience in neuroscience and/or MRI technology highly preferred.
• Proficiency in regulatory requirements, including ICH-GCP and FDA guidelines.
• Excellent communication and interpersonal skills.
• Demonstrated problem-solving abilities and attention to detail.
• Familiarity with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
• Ability to work both independently and collaboratively in a fast-paced environment.

Preferred Experience:

• Master's degree in Biomedical or Neuroscience Sciences or related field
• Hands-on experience in post-market clinical studies.
• Exposure to medical device development, particularly Class II devices

Physical Demands:

• This is an onsite role based out of Hyperfine's office in Palo Alto, CA (minimum 3 days per week)
• Travel up to 25% of the time.

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship now or in the future of any employment Visa.

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