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Health Services Researcher

Abbott Laboratories

This is a Full-time position in Los Angeles, CA posted July 19, 2021.

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries.

For years, Abbott’s medical device businesses have offered technologies that are faster, more effective, and less invasive. Whether it’s glucose monitoring systems, innovative therapies for treating heart disease, or products that help people with chronic pain or movement disorders, our medical device technologies are designed to help people live their lives better and healthier. Every day, our technologies help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine ?ngersticks. 

The Senior Clinical Research Associate works independently with minimal guidance and direction, assists in the planning and conduct of Abbott clinical studies. Ensures compliance to study protocol, domestic and international Good Clinical Practices, applicable regulatory standards, and Abbott Standard Operating Procedures. Able to solve complex problems; considers alternative or new perspectives using existing tools and standard processes. 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.

WHAT YOU’LL DO

  • Ensures both regulatory and clinical protocol compliance is maintained for all assigned clinical projects. This may include but is not limited to:

  • 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. Can function to lead calls with FCE management if required.

  • Provides product/protocol specific support and training to internal and external clinical personnel.

  • In consultation with study management, the assigned field clinical personnel and appropriate inhouse personnel, coordinates the start-up and maintenance of the clinical study sites.

  • Coordinates and lead activities with study specific committees, vendor services, and core labs.

  • Reviews and analyzes data and documents for accuracy and completeness. Can lead study team to clean and review data. 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. Can lead team meetings reviewing compliance concerns.

  • 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.

  • Communicates and collaborates with all levels of employees, customers, contractors, and vendors.

  • Applies general clinical research processes and regulatory knowledge to actively improve processes and efficiencies.

  • Mentors less experienced clinical team members.

  • Contributes to global process improvement teams.

  • Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates effectiveness and appropriateness.

  • Exercises independent judgment in planning, organizing, and performing work; monitors performance and reports status to manager.

  • Provides input to departmental Standard Operating Procedures (SOPs) and Departmental Work

EDUCATION AND EXPERIENCE YOU’LL BRING

Required

  • A Bachelor degree from an accredited university or college. Preferably with an academic focus in natural science, pre-medicine, nursing, bioengineering, or a related academic field.

  • Minimum five years clinical research experience.

  • Must have demonstrated strong written and verbal communication, interpersonal, presentation, analytical, organizational, technical writing, and problem solving
    skills.

  • Proficiency in Microsoft Office Suite and relevant clinical applications.

Preferred

  • Advanced degree preferred with an academic focus in natural science, nursing,
    bioengineering or a related academic field.

  • An excellent understanding of all aspects of clinical research. A general
    familiarity with cardiac, vascular, and/or neuromodulation 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).

  • Work habits include organization, coordination of many tasks, accuracy, and
    attention to detail.

  • The ability to work independently when necessary.

  • The ability to exchange straightforward information, ask questions, and check for understanding.

WHAT WE OFFER

At Abbott, you can have a good job that can grow into a great career. We offer:

  • Training and career development, with onboarding programs for new employees and tuition assistance

  • Financial security through competitive compensation, incentives and retirement plans

  • Health care and well-being programs including medical, dental, vision, wellness and occupational health programs

  • Paid time off

  • 401(k) retirement savings with a generous company match

  • The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:  www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.