Senior Clinical Research Associate

Summary

Join Synchron, a clinical-stage endovascular brain computer interface (BCI) company, as a Senior Clinical Research Associate. You will play a crucial role in setting up and executing groundbreaking studies, working with the Sr. Director, Clinical Operations. Responsibilities include conducting qualification, initiation, monitoring, and closeout visits at research sites; completing monitoring visit reports; verifying medical records; ensuring IRB/EC submissions; serving as a liaison between Synchron and investigative sites; verifying investigator qualifications; contributing to the development of trial documentation; supporting study progress tracking and reporting; assisting with documentation, audit readiness, and inspection compliance; assisting with TMF setup and oversight; supporting vendor oversight; and ensuring adherence to GCP and regulatory requirements. The position requires a Bachelor’s or Master’s degree in Life Sciences or a related field, minimum 5 years of clinical research experience (3 years of onsite monitoring), strong understanding of GCP, FDA, and ICH guidelines, and excellent communication and organizational skills. Domestic and international travel is required. Preferred qualifications include experience with medical devices, neurology, or BCI trials, experience monitoring Class III implantable devices, and familiarity with EDC, TMF, and CTMS systems. The salary range is $130k-$150k.

Requirements

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

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

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)

Benefits

$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.)