Senior Clinical Scientist

Abbott•Sylmar, MD
•$90,000 - $180,000•Onsite

About The Position

The Senior Clinical Scientist works independently with minimal guidance to assist in planning and conducting clinical studies. The role ensures compliance with study protocols, domestic and international Good Clinical Practices, applicable regulatory standards, and Standard Operating Procedures. It focuses on site management, including collecting essential documents, identifying and obtaining missing data, correcting data, and reviewing and trending adverse events and protocol deviations. The scientist may develop study materials, assist with writing reports and protocols, and oversee vendors and committees such as core labs and safety boards. This is an onsite position based in Sylmar, California, within Abbott’s Cardiac Rhythm Management division. The role requires independent judgment, collaboration across internal and external teams, and contributions to mentoring and process improvement.

Requirements

  • Bachelor’s degree in natural science, pre-medicine, nursing, bioengineering, or a related academic field, or an equivalent combination of education and work experience.
  • At least 5 years of experience in a clinical, medical, or research setting.
  • Strong written and verbal communication, interpersonal, presentation, analytical, organizational, technical-writing, and problem-solving skills.
  • Ability to interpret clinical data, meet deadlines, and work effectively with employees at all levels.
  • Proficiency in Microsoft Office Suite and relevant clinical applications.
  • Ability to work independently when necessary.
  • Ability to exchange straightforward information, ask questions, and check for understanding.

Nice To Haves

  • Master’s degree.
  • Excellent understanding of all aspects of clinical research.
  • General familiarity with cardiac, vascular, and/or neuromodulation technologies.
  • Related research experience in a clinical or corporate setting, or relevant clinical experience in a clinical or hospital environment.
  • Research Professional certification from the Society of Clinical Research Associates (SoCRA) or the Association of Clinical Research Professionals (ACRP).
  • Organized work habits, ability to coordinate many tasks, accuracy, and attention to detail.

Responsibilities

  • Ensure regulatory and clinical protocol compliance for assigned clinical projects.
  • Draft study materials, including patient brochures, recruitment materials, presentations, protocol summaries, annual reports, other study reports, and informed consent documents.
  • Develop draft Case Report Forms and associated edit logic for review.
  • Assist with site nomination, qualification, and selection; lead calls with FCE management when required.
  • Provide study conduct and protocol-specific support and training to internal and external clinical personnel.
  • Coordinate clinical study site start-up and maintenance in consultation with study management, field clinical personnel, and appropriate in-house personnel.
  • Coordinate and lead activities with study-specific committees, vendor services, and core labs.
  • Review and analyze data and documents for accuracy and completeness; lead study-team data cleaning and review when needed.
  • Create and process data queries.
  • Assist with preparation, follow-up, and resolution of findings from monitoring visits and audits.
  • Independently review site compliance, raise issues to study management, and lead team meetings concerning compliance issues when needed.
  • Review and process product complaints and adverse events promptly after they are reported.
  • Draft Serious Adverse Event or death narratives.
  • Respond to protocol-related issues as a liaison to field clinical and site personnel, escalating issues as appropriate.
  • Communicate and collaborate with employees at all levels, customers, contractors, and vendors.
  • Apply clinical research processes and regulatory knowledge to improve processes and efficiencies.
  • Mentor less experienced clinical team members and contribute to global process improvement teams.
  • Identify and use effective, cost-efficient business practices, and continually evaluate their effectiveness and appropriateness.
  • Plan, organize, and perform work using independent judgment; monitor performance and report status to the manager.
  • Provide input to departmental Standard Operating Procedures and Departmental Work Instructions.
  • Develop knowledge of current clinical regulations and industry practices, participate in relevant professional associations or societies, and pursue continuing education on division devices and therapies.
  • Manage small projects and process-improvement efforts supporting departmental goals and objectives.
  • Participate in Core Team activities and make additional contributions as assigned.

Benefits

  • Free medical coverage for employees through the Health Investment Plan (HIP) PPO.
  • Retirement savings plan with a high employer contribution.
  • Tuition reimbursement.
  • Freedom 2 Save student debt program.
  • FreeU education benefit, offering a path to a bachelor’s degree.
  • Career development opportunities with an international company.
  • Participants who complete a short wellness assessment qualify for free HIP PPO coverage in the next calendar year.
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