Abbott Senior Clinical Research Associate 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.

JOB DESCRIPTION:

Position Summary:

Working 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 SJM 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.

Essential Functions:

  1. Ensures both regulatory and clinical protocol compliance is maintained for all assigned clinical

projects. This may include but is not limited to:

a.) Drafts study related materials such as: patient brochures, patient recruitment material, and

presentations.

b.) Drafts protocol summary, annual report, and other study reports.

c.) Drafts informed consent documents and ensures all required elements are included.

d.) Develops for review draft Case Report Forms and associated edit logic.

e.) Assists with site nomination, qualification, and selection processes. Can function to lead calls

with FCE management if required.

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

g.) 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.

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

i.) Reviews and analyzes data and documents for accuracy and completeness. Can lead study team

to clean and review data. Creates and processes data queries.

j.) Assists with preparation, follow-up, and resolution of findings from monitoring visits and audits.

k.) Independently reviews site compliance and raises issues to study management. Can lead team

meetings reviewing compliance concerns.

l.) Reviews and processes product complaints and adverse events as soon as they are reported.

m.) Drafts Serious Adverse Event or death narratives.

  1. Serves as a liaison to field clinical and site personnel by responding to any protocol-related issues and

escalating as appropriate.

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

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

and efficiencies.

  1. Mentors less experienced clinical team members.

  2. Contributes to global process improvement teams.

  3. Identifies and routinely uses the most effective, cost efficient and best business practices to execute

processes; continually evaluates effectiveness and appropriateness.

  1. Exercises independent judgment in planning, organizing, and performing work; monitors

performance and reports status to manager.

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

Instruction (DWIs).

Required Qualifications:

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. 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 Qualifications:

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.

JOB FAMILY:

Medical & Scientific Affairs

DIVISION:

ASJM Abbott St. Jude Medical

LOCATION:

United States > Minnesota : 5050 Nathan Lane N.

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

No

MEDICAL SURVEILLANCE:

Not Applicable

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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