Clinical Research Associate

Job Title: Site ICRA I

Location: Maple Grove, MN

Duration: 8-month contract (likelihood of extension)

Position Summary:

Participates in the planning and execution of Abbott clinical studies at the assigned study sites.

Supports 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. Uses existing procedures to solve routine or standard problems. Supports collection of essential

regulatory documents, obtaining missing data and data corrections, and review of protocol deviations

in cooperation with Data Review.

Essential Functions:

• Supports regulatory and clinical protocol compliance for all clinical projects at the assigned

sites.

• In partnership with the assigned Abbott field staff and in-house personnel, coordinates the start-

up, maintenance and close out of the assigned clinical study sites.

• May review informed consent documents to ensure all required elements are included.

• Reviews and analyzes study data, regulatory documents for accuracy and completeness,

supports data queries resolution.

• Supports the follow-up and resolution of findings from monitoring visits and audits on the

assigned study sites.

• Serves as a liaison to clinical study management, site management personnel and site personnel

by responding to protocol-related issues and escalating as appropriate.

• Acts as a primary contact for the assigned study sites.

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

vendors.

• Applies general clinical research processes and regulatory knowledge to process improvement

activities.

• Supports training of external clinical professionals to ensure compliance with established

protocols.

• Performs review of site compliance under supervision and escalates issues to site operations

management and/or study management.

• Updates and maintains internal clinical trial information and document management systems

including trial master file management.

• Collect and maintain regional and study site-specific communication to facilitate activation and

execution of clinical studies at the assigned study sites.

• May contribute to global or regional process improvements.

Other Duties:

• Have a good understanding of current clinical regulations and common industry practices,

engages in relevant professional associations or societies, and seeks continuing education about

Abbott devices and therapies.

• May make additional contributions as assigned

Qualifications:

• Required: Bachelor’s degree preferably with an academic focus in natural science, pre-

medicine, nursing, bioengineering with a minimum of two years of experience, or an equivalent

combination of education and experience

• Must have 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.

• Must be proficient in Microsoft Office Suite.

• Able to work independently, seeking guidance when necessary.

• Capable of exchanging information, ask questions, and check for understanding.

Desired:

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).

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