Clinical Research Associate

Si-Bone • Santa Clara, CA

286d • $73,000 - $81,000 • Remote

About The Position

SI-BONE is a fast-growing, publicly traded medical device company that is an industry pioneer in minimally invasive sacropelvic solutions. Our mission is to help patients rise up and reach for the stars, and our vision is to work together as the global leader to make sacropelvic conditions universally recognized and effectively treated through innovation, evidence, education, and advocacy. This position is a remote opportunity, but candidates must be central or east coast based and near a major airport as this role requires significant travel. 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 looking for people who are passionate about our mission and who are willing to work hard to achieve it.

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.
• Bachelor's degree in health science field preferred.
• Travel fluency.

Nice To Haves

• 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.
• Knowledge and familiarity of applicable regulations/standards (e.g. ISO 13485, FDA 21 CFR 820, EU MDR 2017/745, ISO 14971, ISO 14155).

Responsibilities

• Manage clinical study sites and coordinate activities to ensure overall compliance with the protocol and clinical objectives.
• Conduct site qualification, initiation, interim monitoring, and close out visits.
• Ensure high-quality data through remote and onsite monitoring, acting as the study protocol expert and key resource for site staff.
• Routinely review the Investigator Site File (ISF) for accuracy, timeliness and completeness.
• Actively manage site compliance with the protocol including enrollment, follow up visits, timely and accurate data entry.
• Contribute to the preparation of study related documents including CRFs, ICF, clinical monitoring plan.
• Understand therapeutic area for assigned clinical projects.
• Support the SI-BONE Quality System, adhere to company policies, and perform mandated trainings on time.

Benefits

• Salary range: $73,000 - $81,000.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Merchant Wholesalers, Durable Goods
• Education Level: Bachelor's degree