Abbott Clinical Research Associate II in Plymouth, Minnesota
At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 94,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve. Please note that candidates need to be eligible to work in the U.S. without Abbott sponsorship.
We are seeking an experienced, high caliber Clinical Research Associate II. Working with a moderate level of 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 a range of straightforward problems and analyze possible solutions using standard 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 and assist with writing reports. May also assist with the oversight of vendors and committees such as core labs and safety boards.
Impact this role will have on Abbott:
Ensures both regulatory and clinical protocol compliance is maintained for all assigned clinical projects. This may include but is not limited to:
Assists in the development of study related materials such as: patient brochures, patient recruitment material, and presentations
Assists in writing sections of the protocol summary, annual report, and other study reports
Assists in the development and review of informed consent document to ensure all required elements are included
Assists with site nomination, qualification, and selection processes
In consultation with the assigned field clinical and appropriate in-house personnel, coordinates the start-up and maintenance of the clinical study site
Coordinates 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
Reviews and processes product complaints and adverse events as soon as they are reported
Drafts Serious Adverse Event narratives.
Serves as a liaison to clinical study management, field clinical personnel and site personnel by responding to any protocol-related issues and escalating as appropriate
Ensures the clinical study site adheres to the assigned protocol and all applicable regulatory standards
Notify appropriate study management when concerns exit
Communicates and collaborates with all levels of employees, customers, contractors, and vendors
Applies general clinical research processes and regulatory knowledge to process improvement activities
Have a good understanding of current clinical regulations and common industry practices, engages in relevant professional associations or societies, and seeks continuing education about devices and therapies
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 two years clinical research experience
Must have demonstrated strong written and verbal communication, interpersonal, presentation, analytical, organizational skills, and the ability to interpret basic clinical data, to meet deadlines as well as the ability to communicate effectively with all levels of employees
Familiarity with Microsoft word, Excel and Outlook programs and relevant clinical applications
The ability to work independently when necessary
The ability to exchange straightforward information, ask questions, and check for understanding
Work habits include organization, coordination of many tasks, accuracy, and attention to detail
Your preferred qualifications and education:
A general familiarity with clinical trials research processes
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)
Medical & Scientific Affairs
ASJM Abbott St. Jude Medical
United States > Minnesota : 5050 Nathan Lane N.
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)
Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.
EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf
EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf
Abbott is about the power of health. For more than 125 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 150 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.
The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges.
We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
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