Clinical Research Program Specialist

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 (CRPS) plays a critical role in the lifecycle of SI-BONE’s evidence portfolio. This individual takes a leadership position within the team, working cross-functionally to design and implement clinical research projects. They creatively solve problems, identify data opportunities, and obtain, analyze, and work with physicians to prepare abstracts and manuscripts.  The CRS is a subject matter expert who monitors the clinical landscape and drives evidence generation to support regulatory submissions,  market access, and physician adoption. 

The CRPS oversees all aspects of data for the clinical team. This may include clinical site monitoring, both remote and onsite, the goal of which is to ensure high-quality study data and maintain good site relations. They maintain a high level of professional expertise through reading literature, attending society meetings, and interfacing with physician customers.

The CRPS works closely with the regulatory and product teams to provide SME input on regulatory submissions and promotional material review.

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.

Responsibilities may include the following and other duties may be assigned:

• Author protocols, investigator brochures, and other relevant deliverables related to scientific perspectives of the clinical study
•  Provide scientific expertise to clinical trial managers on scientific issues related to the study conduct and serve as a resource to address any questions or clarify issues arising during the conduct of the study
•  Prepare scientific publications and conference abstracts/presentations for effective clinical evidence dissemination within the therapy field
•  Build and maintain optimal relationships and effective collaborations with various internal (e.g., cross-functional team) and external parties (e.g., key opinion leaders, regulatory authorities) 
•  Understand the current clinical landscape and future implications for relevant indications/ patient populations to help drive strategy and marketing opportunities
•  Perform data monitoring, cleaning, analysis, and safety monitoring as needed
•  Author clinical study reports, annual reports, clinical evaluation reports, and other clinical documents for regulatory submissions 
• Conduct systematic literature reviews to support stand-alone projects, protocols, clinical evaluation reports, or other evidence-based summary of clinical literature

• Ensures high quality data by being the study protocol expert and key site resource for questions
• Other projects may be assigned related to evidence generation or product support as needed
• Support the SI-BONE Quality System

Knowledge, Education, and Experience:

• Knowledge of medical terminology
• Strong understanding of statistics with the ability to interpret data in a meaningful way
• Agile and able to change direction as needed
• Creative problem solver and critical thinker
• Ability to identify and solve problems independently
• 3+ years clinical research experience, or advanced degree with experience working with nurses and physicians 
• Advanced degree in health or science related field required.
• Travel fluency & Ability to travel at least 25%

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. 
• Knowledge and familiarity of applicable regulations/standards (e.g. ISO 14155, FDA 21 CFR 812, 822, 803, ICH E6, EU MDR 2017/745) 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