Abbott Jobs

Mobile abbott Logo

Job Information

Abbott Senior Study Clinical Research Associate (CRA) in Maple Grove, Minnesota

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 103,000 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

Individual contributor participating in the execution of Abbott clinical studies. Ensures compliance to study protocol, domestic and international Good Clinical Practices, applicable regulatory standards, and 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 also manage subject eligibility committee depending on trial needs.

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:

  • Supports Clinical Project Manager in key study execution tasks, including collaboration/communication with differing levels of internal and external stakeholders.

  • Serves as a liaison to clinical project management and site management personnel related to study activities and questions.

  • Acts as subject matter expert for internal clinical processes.

  • Develops study-specific materials such as training slides, document templates (i.e. DoA, training logs), and newsletters.

  • As applicable, manages all aspects of subject eligibility committee work including: screening pipeline oversight, presentation preparation, organization of meetings, and tracking of meeting outcomes. Effectively and confidently interface with Customers/KOLs, Physician Members, National Principal Investigators, Field Clinical, Medical Directors, and Clinical Science, Research and Development, and other internal personnel.

  • Assists with site 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 in-house personnel, coordinates the start-up and maintenance of the clinical study sites.

  • Reviews and updates, where applicable, documents (e.g. study document templates and site activation regulatory documents) for accuracy and completeness. Assists with preparation, follow-up, and resolution of findings from monitoring visits and audits.

  • 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.

  • 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.

Other Duties:

Develops an understanding of current clinical regulations and common industry practices, engages in relevant professional associations or societies, and seeks continuing education about SJM devices and therapies. Manages small projects and process improvement efforts that are critical to help support departmental goals and objectives. May participate in Core Team activities and make additional contributions as assigned.

Equipment:

Uses standard office equipment, including (but not limited to) personal computer, telephone, FAX, and copier.

Working Conditions:

Normally works in a cubicle situated in open landscape office environment. Air conditioned. Well lighted. Moderate noise level.

Physical Demands:

Primarily sitting. Some walking. Light effort related to moving, lifting and using office supplies and standard office items. Performs tasks which regularly require good correctable vision and hand/eye coordination.

This position may require up to approximately 25% travel.

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, bio engineering, or a related academic field.

• Minimum 5 years of clinical research experience.

• 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.

• The ability to exchange 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:

  • 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.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com

DirectEmployers