Senior Clinical Research Associate

About Synchron 

Synchron is a neurotechnology company with a mission to deliver the first commercially scalable brain-computer interface (BCI) for millions of people with paralysis to reconnect with the world. Our minimally invasive BCI system is designed to enable users to control digital devices directly through thought, restoring access and control over the digital world. Our team is working at the intersection of healthcare and technology to translate breakthrough research into real-world care.

Join us in shaping a more connected and accessible future. 

Position Summary

The Senior Clinical Research Associate will play a crucial role in the set-up and execution of groundbreaking studies.  This position will work together with the Sr. Director, Clinical Operations on the study start-up and infrastructure items from the initial phases of study set-up to hands-on clinical monitoring and site management. 

Responsibilities

• Conduct qualification, initiation, monitoring, and closeout visits at research sites in accordance with approved protocol(s), GCP, SOPs, and applicable regulatory requirements.
• Complete monitoring visit reports and visit letters that includes complete summaries and accounts of onsite activities.
• Verify medical record and source documentation against case report form (CRF) data, including informing the site staff of any entry errors, ensuring good documentation practices (GDP) are being adhered to and communicating protocol deviations appropriately per SOPs, GCP, and applicable regulatory regulations.
• Ensure IRB/EC submissions and applicable regulatory documentation with proactive follow-through to ensure site readiness and study progress.
• Follow-up with clinical sites on all open action items, IRB/EC submissions, and subject status
• Serve as the primary operational liaison between Synchron and investigative sites, focused on study conduct, protocol execution, data integrity, and patient safety.
• Verify adequate investigator qualifications, training resources, sufficient study staff, and appropriate investigator oversight.
• Contribute to the development of case report forms , informed consent documents, and other essential trial documentation.
• Support tracking and reporting study progress including site performance and data collection.
• Assist with ensuring proper documentation, audit readiness, and inspection compliance
• Assist with TMF (Trial Master File) setup and oversight.
• Support vendor oversight and management to ensure adherence to contracted deliverables.
• Ensure adherence to GCP, ICH guidelines and applicable regulatory requirements.

Qualifications

Minimum Education:

Bachelor’s or Master’s degree in Life Sciences or related field.

Minimum Experience:

• Minimum 5 years of clinical research experience, with at least 3 years of onsite monitoring.
• Strong understanding of GCP, FDA, ICH guidelines, regulations, and compliance requirements (e.g. 21 CFR 812, ISO14155).
• Proven ability to multi-task, prioritize workload effectively, and meet deadlines in a fast-paced environment.
• Excellent interpersonal, communication, and organizational skills with a high affinity for collaboration.
• Results driven and effective at working at all levels of an organization.
• Clear and concise in verbal and written communication.
• Ability to travel domestically and internationally, as required, >60% during peak times

Preferred Qualifications:

• Experience with medical devices, neurology, neuromodulation or Brain Computer Interface (BCI) trials.
• Experience monitoring a Class III implantable device
• Proficiency in Microsoft Office Suite
• Familiarity with EDC, TMF and CTMS systems.
• Experience working in a fast-paced medical device startup environment (preferred)

Salary

$130k-$150k (The posted range reflects the targeted hiring range for this position. Our full compensation bands for this level may be broader and account for growth and performance over time.)

At Synchron, we value our culture and the way we work together to achieve our goals. You will be amongst a group of hard-working, fun, and caring people who support each other and are passionate about bringing life-changing technologies to people with disabilities.

Synchron provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. 

Synchron operates in the USA. 

Benefits* 

• Subsidized medical and dental insurance coverage for you and your dependent(s)  
• Life insurance, short-term disability, long-term disability 
• 401k 
• Discretionary unlimited PTO 
• Flexible Spending Account for you and your dependent(s) 
• Commuter benefits for NY employees including a Lyft CitiBike membership 

*for full-time, exempt employees 

Equal Employment Opportunity (EEO)  

Synchron is an equal opportunity employer. We are committed to creating an inclusive environment for all employees and applicants and provide equal employment opportunities without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, veteran status, or any other characteristic protected by applicable law. 

If you need a reasonable accommodation during the application or interview process, please let us know. 

Join Us 

At Synchron, you will be part of a transformative mission and you will work alongside driven people who believe in the power of collaboration and innovation to make a lasting impact. If you are excited to stretch your skills and contribute to something meaningful, apply and now and build the future with us.