Clinical Research Associate

Summary

Join SI-BONE, a leading medical device company, as a Clinical Research Associate (CRA) and play a key role in the lifecycle of our clinical studies. This remote opportunity, based in the central or east coast near a major airport, requires significant travel. As CRA, you will manage clinical study sites, ensuring compliance with protocols and objectives. You will conduct site visits, monitor data quality, and maintain strong site relationships. The role demands expertise in clinical research, regulatory compliance, and strong communication skills. SI-BONE offers a competitive salary and a purpose-driven work environment.

Requirements

• Knowledge of medical terminology
• Strong problem-solving skills
• Basic understanding of summary statistics
• Agile and able to change direction as needed
• Ability to identify and solve problems independently
• 2+ years clinical research experience, or advanced degree with experience working with nurses and physicians
• Travel fluency
• Writing sample (monitoring report and follow up letter) required for review
• Knowledge and familiarity of applicable regulations/standards (e.g. ISO 13485, FDA 21 CFR 820, EU MDR 2017/745, ISO 14971, ISO 14155) as required to perform the job function

Responsibilities

• Conducts site qualification, initiation, interim monitoring, and close out visits
• Ensures high-quality data through remote and onsite monitoring, acting as the study protocol expert and key resource for site staff, while guiding them and resolving queries within agreed timelines
• Routinely reviews the Investigator Site File (ISF) for accuracy, timeliness and completeness, reconciling it with the Trial Master File (TMF), and ensuring the site is aware of the requirement of archiving essential documents in accordance with local guidelines and regulations
• Actively manages site compliance with the protocol including enrollment, follow up visits, timely and accurate data entry through frequent site review and communication
• Contributes to the preparation of study related documents including CRFs, ICF, clinical monitoring plan
• Understands therapeutic area for assigned clinical projects
• Supports the SI-BONE Quality System, adheres to company policies, and performs mandated trainings on time
• The CRA manages clinical study sites and coordinates activities to ensure overall compliance with the protocol and clinical objectives. This includes clinical site monitoring, both remote and onsite, the goal of which is to ensure high-quality study data and maintain good site relations
• The CRA is responsible for performing all duties in compliance with all applicable corporate policies and worldwide regulatory requirements as included in the scope of the SI-BONE Quality Manual
• The employee must act and conduct company business in an honest, ethical and lawful manner, consistent with the company’s policies and AdvaMed Code of Conduct. The company does not tolerate retaliation in connection with making good faith reports of suspected violations

Preferred Qualifications

• Bachelor’s degree in health science field
• Self-starter
• Friendly outgoing personality who can build trust and rapport with physicians and study coordinators
• Organized and efficient, this person should be a true team player with excellent verbal and written communication skills

Benefits

• Salary range: $73,000 - $81,000
• Remote opportunity