[Hiring] Clinical Research Program Specialist @SI-BONE, Inc

Role Description

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.

• Manage clinical study sites and coordinate activities to ensure overall compliance with the protocol and clinical objectives.
• Conduct clinical site monitoring, both remote and onsite, to ensure high-quality study data and maintain good site relations.
• Maintain a high level of professional expertise through reading literature, attending society meetings, and interfacing with physician customers.
• Collaborate with study team to draft materials including case report forms, site presentations, and other documents as applicable.
• Perform all duties in compliance with all applicable worldwide regulatory requirements as included in the scope of the SI-BONE Quality Manual.
• Act and conduct company business in an honest, ethical, and lawful manner, consistent with the company’s Code of Conduct.

Qualifications

• 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.

Requirements

• Up to 25% travel.
• Support all phases of clinical development and execution.
• Conduct site qualification, initiation, interim monitoring, and close out visits.
• Train sites on protocol, process, systems, and study management.
• Ensure high-quality data by being the study protocol expert and key site resource for questions.
• Data monitoring both remote and onsite.
• Collect and maintain site essential documents.
• Maintain and track 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.
• Understand therapeutic area for assigned clinical projects.
• Support the SI-BONE Quality System.

Benefits

• Salary range: $102,000 - $120,000.
• Supplemental pay: bonus and stock.