Clinical Research Scientist

What You'll Work On

• Contribute to the development, review, and maintenance of study-related documents including clinical study protocols, protocol amendments, case report forms, investigator brochures, informed consent forms, study manuals, clinical study reports, and associated scientific documentation.
• Support the planning, execution, analysis, and reporting of prospective clinical studies, registries, observational studies, post-market studies, and other evidence-generation activities.
• Conduct literature reviews, scientific assessments, competitive analyses, and evidence evaluations to support protocol development, endpoint selection, publication activities, clinical strategy discussions, and evidence-generation planning.
• Collaborate with clinical operations and CRO partners to support study execution activities, enrollment monitoring, site communications, protocol compliance activities, issue identification, and study-risk mitigation efforts.
• Review clinical data listings, summary tables, statistical outputs, and study reports and contribute to interpretation of study outcomes, safety findings, and clinical evidence.
• Participate in scientific data reviews and contribute to analyses supporting study conclusions, publication activities, clinical evaluation activities, and evidence-generation initiatives.
• Contribute to development of scientific manuscripts, abstracts, posters, white papers, podium presentations, and other scientific communications intended for internal and external audiences.
• Support publication activities through scientific writing, literature reviews, data review, and collaboration with internal teams and external authors.
• Contribute to compilation and organization of clinical evidence supporting regulatory submissions, clinical evaluations, reimbursement activities, and regulatory authority responses.
• Support maintenance of clinical study documentation, inspection readiness activities, audit activities, and compliance with quality system requirements.
• Participate as an active member of study teams and contribute scientific input during protocol development, study execution, data analysis, and reporting activities.
• Communicate scientific findings, study progress, and project updates to department stakeholders.
• Develop working knowledge of electrophysiology therapies, cardiovascular disease states, product technologies, clinical evidence, and evolving treatment paradigms.
• Build collaborative working relationships with investigators, research coordinators, study sites, and cross-functional business partners.

Required Qualifications

• Bachelor's degree in Life Sciences, Biological Sciences, Biomedical Sciences, Biomedical Engineering, Bioengineering, Public Health, Epidemiology, Nursing, Medicine, Pharmacy, or related scientific discipline.
• Minimum experience equivalency: BS + 2-4 years relevant experience; MS + 0-2 years relevant experience; PhD + 0 years relevant experience.
• Demonstrated scientific writing ability.
• Foundational understanding of clinical research methodology, clinical trial design, and evidence generation.
• Ability to critically evaluate scientific literature and apply findings to scientific and clinical research questions.
• Foundational understanding of statistical concepts including study endpoints, hypothesis testing, confidence intervals, and interpretation of clinical study results.
• Effective written and verbal communication skills with the ability to communicate scientific information to cross-functional stakeholders.
• Working knowledge of Good Clinical Practice and clinical research regulations.
• Ability to work effectively within multidisciplinary project teams.
• Strong organizational skills with the ability to manage multiple priorities and deadlines.
• Broad knowledge and application of business concepts, procedures, and practices.

Preferred Qualifications

• Advanced degree preferred.
• Medical device clinical research experience.
• Knowledge of electrophysiology therapies and cardiovascular clinical research.
• Experience supporting clinical trials or investigator-sponsored research.
• Working knowledge of clinical trial statistics including endpoints, confidence intervals, p-values, and hypothesis testing.
• Familiarity with FDA, MDR, ISO 14155, HIPAA, and GDPR requirements.
• Experience authoring or contributing to scientific manuscripts, abstracts, posters, or presentations.