Clinical Research Program Specialist
About the role
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 collaboration with clinical sites, investigators, and key opinion leaders