Specialist, Clinical Safety (US Remote)

Job Description

• Provide all required clinical safety support to assigned clinical studies, including study safety documentation development, adverse events (AE) review, safety investigations, and startup/management of independent safety committees/ adjudicators. 
• Draft, review, and provide input to the clinical safety components of clinical study protocols, study reports, safety manuals, safety CRFs, study supporting materials, and other related documentation.
• Review and triage study adverse events and prepare for independent physician or committee review by preparing/tabulating these events, gathering relevant source documentation, and preparing narratives. 
• Schedule and manage the proceedings of physician safety committees including Clinical Events Committees (CECs) and Data Safety Monitoring Boards (DSMBs), as well as the activities of independent Clinical Events Adjudicators (CEAs). 
• Support the selection of physician partners, including CEA/CEC/DSMB delegates and other committee members, and provide all required training.
• Generate and present reports to physician safety committees as well as reports of committee findings and results. 
• Partner with clinical research project managers and Medical Affairs and Safety Manager to ensure safety startup activities and pace of events adjudication aligns with study timeline and milestones and to provide regular progress updates. 
• Support clinical science and regulatory affairs functions by utilizing medical expertise to provide input to study design, clinical evaluation reports, clinical study reports, literature review, risk management, regulatory submissions, questions from regulatory authorities, scientific analyses, and other scientific documentation. 
• Support clinical project management function by utilizing medical expertise to provide input to protocol development, risk/benefit analyses, adverse events review, adverse events reporting, investigator questions, investigator meetings, clinical study reports, and other related documentation/activities. 
• Minimal domestic travel required (1 – 3 trips per year). 
• Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization. 
• Perform additional duties as assigned.

Qualifications

1. RN/BSN or equivalent. 
2. Minimum one (1) to three (3) years of experience providing clinical safety support to regulated clinical device studies or relevant clinical research experience, academic experience, or experience in a hospital setting. 
3. Ability to produce high-quality scientific communications and narratives. 
4. Strong written and verbal communication skills. 
5. Strong interpersonal skills to build effective relationships with geographically diverse physicians and internal business partners. 
6. Strong detail-orientation and organizational/time management skills. 
7. Proficiency in standard computer programs including MS Office (Word, Excel, PowerPoint, Outlook, Teams, etc.). 
8. Ability to maintain strict confidentiality. 

1. MD or foreign equivalent. 
2. Clinical, academic, CRO, or industry experience in a relevant field (neurology, neuroradiology, or neurosurgery). 
3. Knowledge of GCP, FDA, and ICH regulations and guidelines. 
4. Knowledge and experience in the detection, understanding, review, investigation, and assessment of adverse events. 
5. Class III medical device safety experience.

• Extended periods of computer use. 
• Extended periods of sitting or standing. 
• Light lifting, up to 25 lbs.
• May be required within the position to be in an environment that can include radiation exposure (such as in Cathlabs). 
• Minimal domestic travel required (1 – 3 trips per year).