Clinical Research Associate at Precision Neuroscience , NY

Clinical Research Associate job at Precision Neuroscience. New York, NY.

Department: Precision

Location: Manhattan, New York

Compensation: $125,000 - $135,000 / year

Precision Neuroscience is pioneering a brain implant, known as a brain-computer interface (BCI), to restore communication and independence for people with neurological conditions. Our cutting-edge technology is designed to empower people with paralysis to control digital devices—such as computers and smartphones—with their thoughts alone, opening new possibilities for daily life. Precision’s multidisciplinary team brings together leading experts in diverse fields such as neurosurgery, artificial intelligence, machine learning, microfabrication, electrical engineering, and more.

We are committed to turning breakthrough scientific advancements into real-world solutions for people affected by conditions such as spinal cord injury, stroke, and ALS. As a Precision employee, you will be joining one of the fastest moving and best-capitalized companies in the emerging field of BCI. Since our founding in 2021, Precision has secured over $155 million in funding, developed and validated our technology, and initiated human trials in collaboration with some of the nation’s top hospitals.

We are seeking a Clinical Research Associate to play a key role in proactively helping the conduct of pre‑market clinical studies to ensure compliance with regulatory requirements. This is a unique opportunity to be at the forefront of clinical research and contribute to the development of transformative therapies. In this role you will work with key stakeholders to complete study start‑up through execution of clinical studies.

You will design and run clinical studies, review and interpret results, contribute to reports and help the development of clinical publications. You’ll work with clinical study managers, clinicians, clinical site staff, biostatisticians and more. This position is on‑site at our Manhattan (Flatiron neighborhood) office. We may also consider candidates who live in north‑eastern US regions. To be eligible for this role you must currently be based in the United States, and have working rights.

• Collaborate with cross‑functional teams including neuroscientists, neurosurgeons, engineers, clinical research personnel, and regulatory bodies to manage and oversee the clinical trials involving Precision’s microfabricated ECoG array, the Layer 7 device, ensuring optimal performance and compliance with study protocols.
• Manage site start‑up/activation process, including heavy contribution to the preparation of study‑related documents (protocols, case report forms (CRFs) or eCRFs, draft informed consent forms (ICF) and complete checklists, ability to help clinical trial agreements and budget negotiation, clinical monitoring plan). Act as a point of contact for the sites, providing timely resolutions to any issues.
• Maintain and track clinical study data and help in investigator qualification and selection, scrutiny of potential patient recruitment, and overall study status/progress throughout the life of a study.
• Organize IRB/EC submissions and applicable regulatory documentation with follow‑through to ensure successful outcomes.
• Perform on‑site and remote site qualification visits, site initiation visits, interim monitoring visits, and site close‑out visits.
• Conduct clinical study monitoring to ensure regulatory and protocol compliance and overall data accuracy in accordance with the study clinical monitoring plan.
• Assist in developing and implementing strategies for clinical conference and publication planning; identify and support key opportunities for showcasing research findings.
• Develop and manage study trial master file and maintain study documentation and clinical trial management system (e.g., correspondence, CRFs, study approval documents), trip reports, site contact documentation, monthly status reports (e.g., enrollment, adverse events, budget, etc.)
• Collaborate with statisticians to develop statistical analysis plans, and review data analysis and preparation of statistical reports ensuring accuracy and integrity.