Job Description

Clinical Research Associate

Department: Precision

Employment Type: Full Time

Location: Manhattan, New York

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

Description

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.

Key Responsibilities

• 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, able 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.

Skills, Knowledge and Expertise

• Bachelor's degree or above in life sciences, biomedical engineering, biostatistics, or a related field; Master's degree is a plus.
• 2+ years' experience within the US as a Clinical Research Associate, preferably in a medical-device startup.
• Years of experience monitoring clinical studies involving neuro-focused medical devices
• Previous experience implementing, helping and managing medical device trials.
• Significant knowledge of clinical and/or outcomes research study design.
• Advanced knowledge of Clinical investigation of medical devices for human subjects - Good Clinical Practice (ISO 14155), 21 CFR Part 11, 50, 54, 812 and other applicable regulations, fundamental knowledge of clinical research and monitoring requirements.
• Experience interacting with physicians and other professionals inside and outside the company.
• Experience in protocol and ICF development, writing clinical section(s) for regulatory submission.
• Experience negotiating clinical research contracts and budgets.
• Excellent organizational, communication, and interpersonal skills.
• Attention to detail and strong problem-solving abilities.
• Ability to convey technical concepts to non-technical audiences.
• Independent self starter with proven ability to thrive in fast-paced environments, work effectively on tight timelines, and adapt to changing priorities.

Preferred Experience:

• Prior experience working in a clinical/healthcare setting.
• Strong statistical knowledge and experience in data analysis; proficiency in statistical software (e.g., SAS, R, or similar).

Diverse workforces create the best culture, company, and products. We at Precision are committed to an inclusive culture that celebrates the uniqueness and contributions of everyone.

As an equal opportunity employer, Precision does not discriminate on the basis of sex, race, religion, national origin, disability status, protected veteran status, or any other characteristic protected by law.

Job Tags

Full time, Interim role, Remote job,

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