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 fingersticks.
SUMMARY OF THE ROLE
Participates in the planning and execution of Abbott clinical studies in the assigned study sites. Exercises independent judgment in planning, organizing, and performing work; monitors performance and reports status to manager. Ensures timely site activation, compliance to study protocol, domestic and international Good Clinical Practices, applicable regulatory standards, and Abbott Standard Operating Procedures during study activation, execution and close out phase in close cooperation with the assigned Site Management Team. Able to solve complex problems; considers alternative or new perspectives using existing tools and standard processes. Primary focus is on providing and leading support of site management activities such as collection of essential regulatory documents, obtaining missing data and data corrections. Review of protocol deviations in cooperation with Data Review Team.
WHAT YOU’LL DO
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Ensures regulatory and clinical protocol compliance for all assigned clinical projects in the assigned sites and/or region.
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May act as a study expert for assigned clinical projects.
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May act as a subject matter expert for internal clinical processes.
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Provides support and training to internal and external clinical personnel regarding the assigned clinical study protocol and/or internal processes.
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In partnership with Abbott assigned field staff and in-house personnel; coordinates the start-up, maintenance and close out of the assigned clinical study sites and/or region.
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Acts as a primary contact for the assigned study sites.
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Reviews and analyzes data and documents for accuracy and completeness.
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Supports data query resolution.
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Supports the follow-up and resolution of findings from monitoring visits and audits in the assigned study sites and/or region.
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Updates and maintains internal clinical trial information- and document management systems.
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Serves as a liaison to clinical study management, site management and site personnel by responding to any protocol-related issues and escalating as appropriate.
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Collect and maintain regional and site-specific communication to facilitate activation and execution of clinical studies at the assigned study sites.
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Communicates and collaborates with all levels of employees, customers, contractors, and vendors.
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Applies general clinical research processes and regulatory knowledge to actively improve processes and efficiencies.
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Mentors less experienced clinical team members.
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Contributes to global or regional process improvements and provides input to departmental Standard Operating Procedures (SOPs) and Departmental Work Instruction (DWIs).
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Identifies and routinely uses the most effective, cost efficient and best business practices to execute processes; continually evaluates effectiveness and appropriateness.
EDUCATION AND EXPERIENCE YOU’LL BRING
Required:
Bachelor’s degree preferably with an academic focus in natural science, pre-medicine, nursing, bioengineering, with a minimum of 5 years clinical research experience.
Must have 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.
Ability to work independently when necessary.
Capable of exchanging straightforward information, ask questions, and check for understanding.
Desired:
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.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
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A fast-paced work environment where your safety is our priority (Include for Manufacturing roles only)
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Production areas that are clean, well-lit and temperature-controlled (Include for Manufacturing roles only)
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Training and career development, with onboarding programs for new employees and tuition assistance
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Financial security through competitive compensation, incentives and retirement plans
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Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
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Paid time off
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401(k) retirement savings with a generous company match
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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: http://www.abbottbenefits.com/pages/candidate.aspx
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.