Clinical Research Associate

SI-BONE® is focused on helping patients in one of the most under-served, under-diagnosed, and under-treated areas in orthopedics, the sacroiliac (SI) joint. SI-BONE developed an innovative, patented implant to fuse the SI joint. The iFuse Implant System® provides a less invasive alternative to traditional sacroiliac (SI) joint fusion surgery and has been used in over 90,000 procedures to date. 

We are a medical device company that is focused on improving the lives of patients with sacroiliac pelvic conditions. We are looking for people who are passionate about our mission and who are willing to work hard to achieve it. We are also looking for people who are: 

• Purpose-Driven: We are purpose-driven in a tireless pursuit of our mission for patients.
• Agile: We work in a fast-paced environment and need to be able to learn and adapt to change quickly. 
• Creative: We embrace creativity, and we need people who are not afraid to challenge the status quo. 
• Team Players: We roll-up our sleeves and work together as one team to achieve our goals. 

Key Responsibilities:

The Clinical Research Associate (CRA) plays a key role in the lifecycle of SI-BONE’s clinical studies. 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 expected to maintain a high level of professional expertise by reading relevant literature, attending meetings, and collaborating with physician customers.

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.

Specific 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.

Knowledge, Education and Experience:

• 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
• Bachelor’s degree in health science field preferred
• Travel fluency

Expertise and Attributes:

• Self-starter is a must for this position
• 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. 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

Salary range: $73,000 - $81,000. The compensation range for this position is specific to the location and is in good faith what SI-BONE expects to pay for the position taking into account the wide variety of factors that are considered in making compensation decisions, including job-related knowledge; skillset; experience, education and training; certifications; and other relevant business and organizational factors.