Senior Clinical Scientist

Main Purpose of the Role

This role is based out of Sylmar, CA and is an ONSITE role. The Senior Clinical Scientist works independently with minimal guidance and direction, assists in the planning and conduct of clinical studies. Ensures compliance to study protocol, domestic and international Good Clinical Practices, applicable regulatory standards, and Standard Operating Procedures. Focus is on site management activities such as collection of essential documents, identifying and obtaining missing data, data corrections, reviewing and trending adverse events and protocol deviations. May contribute to developing study related materials; assists with writing reports and protocols. May also provide oversight of vendors and committees such as core labs and safety boards.

Main Responsibilities

• Ensures both regulatory and clinical protocol compliance is maintained for all assigned clinical projects.
• Drafts study related materials such as patient brochures, patient recruitment material, and presentations.
• Drafts protocol summary, annual report, and other study reports.
• Drafts informed consent documents and ensures all required elements are included.
• Develops for review draft Case Report Forms and associated edit logic.
• Assists with site nomination, qualification, and selection processes.
• Provides conduct/protocol specific support and training to internal and external clinical personnel.
• Coordinates the start-up and maintenance of the clinical study sites.
• Coordinates and leads activities with study specific committees, vendor services, and core labs.
• Reviews and analyzes data and documents for accuracy and completeness.
• Creates and processes data queries.
• Assists with preparation, follow-up, and resolution of findings from monitoring visits and audits.
• Independently reviews site compliance and raises issues to study management.
• Reviews and processes product complaints and adverse events as soon as they are reported.
• Drafts Serious Adverse Event or death narratives.
• Serves as a liaison to field clinical and site personnel by responding to any protocol-related issues and escalating as appropriate.
• Mentors less experienced clinical team members.
• Contributes to global process improvement teams.
• Provides input to departmental Standard Operating Procedures (SOPs) and Departmental Work Instructions (DWIs).
• Manages small projects and process improvement efforts that are critical to help support departmental goals and objectives.

Qualifications

Education: Bachelors Degree (± 16 years) in Natural science, pre-medicine, nursing, bioengineering, or a related academic field. OR an equivalent combination of education and work experience. Masters Degree (± 18 years) preferred.

Experience/Background: Minimum 5 years in clinical or medical or research setting. Must have demonstrated strong written and verbal communication, interpersonal, presentation, analytical, organizational, technical writing, and problem solving skills. Able to interpret clinical data, meet deadlines and work effectively with all levels of employees. Proficiency in Microsoft Office Suite and relevant clinical applications. The ability to work independently when necessary.

Preferred: An excellent understanding of all aspects of clinical research. A general familiarity with cardiac, vascular, and/or neuro modulation technologies. Previous related experience in research within a clinical or corporate setting or relevant clinical experience in a clinical/hospital environment. Certification as a Research Professional by Society of Clinical Research Associates (SoCRA) or Association of Clinical Research Professionals (ACRP).