Clinical Research Program Specialist at SI-BONE, Inc

United States

$102k - $120k

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. 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: 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. General Responsibilities: The Clinical Research Program Specialist plays a key role in the lifecycle of SI-BONE’s clinical studies. This individual works with the team to plan, design, and implement clinical research projects. Additionally, they collaborate cross functionally to gather input from other key departments including regulatory affairs, medical affairs, marketing, and R&D. The CRS 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. Maintains a high level of professional expertise through reading literature, attending society meetings, and interfacing with physician customers. Collaborates with study team to draft materials including case report forms, site presentations, and other documents as applicable. Responsible for performing all duties in compliance with all applicable 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 Code of Conduct, other company policies and the AdvaMed Code of Conduct and/or any other applicable industry code(s) of conduct. The company does not tolerate retaliation in connection with making good faith reports of suspected violations. Specific Responsibilities and Skills: Travel: Up to 25% Supports all phases of clinical development and execution Conducts site qualification, initiation, interim monitoring, and close out visits Train sites on protocol, process, systems, and study management Ensures high quality data by being the study protocol expert and key site resource for questions Data monitoring both remote and onsite Collects and maintains site essential documents Maintains and tracks clinical study data and support in investigator qualification selection, analysis of potential patient recruitment, study site support through the life of the study. Heavy contribution to the preparation of study related documents including CRFs, ICF, clinical monitoring plan Understands therapeutic area for assigned clinical projects Other projects may be assigned related to clinical studies as needed Support the SI-BONE Quality System Knowledge, Education, and Experience: Knowledge of medical terminology Basic understanding of summary statistics with the ability to interpret data in a meaningful way Agile and able to change direction as needed Ability to identify and solve problems independently 3+ years clinical research experience, or advanced degree with experience working with nurses and physicians Bachelor’s degree, Advanced 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 spine surgeons 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) as required to perform the job function Salary range: $102,000 - $120,000. 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. Supplemental pay: bonus and stock There are potential risks associated with the iFuse Implant System. It may not be appropriate for all patients and all patients may not benefit. For additional information on the company or the products including risks and benefits, please visit www.si-bone.com/risks. We are aware of active recruitment scams using the SI-BONE name, in which individuals pose as our recruiters and post fake remote job openings and make fake job offers on the Internet. Please note, we will never make an offer of employment without conducting multiple rounds of interviews face-to-face using secure video-conferencing technology. We will never ask candidates to cash checks or make a payment in order to be considered for a position. SI-BONE only uses company email addresses, which contain “@si-bone.com” to communicate with candidates. If you believe you’ve been a victim of a phishing scam, please visit the Cybersecurity & Infrastructure Security Agency at https://www.cisa.gov/be-cyber-smart/report-incident learn how to report it.