Senior Clinical Research Associate

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.