1+ months
2018-05-162018-07-20

CRA II - Clinical Research Associate - Tendyne

Abbott
Saint Paul, MN

At Abbott, we're committed to helping people live their 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, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.

Primary Job Function

Clinical trial operational site support including all processes related to study start-up. Manages sites through life of trial and closeout. Participate in site selection, 

provide feedback in the protocol development and database development; 

MOPS generation; investigator meetings. May manage the annual report process.

Core Job Responsibilities

Responsible for compliance with applicable Corporate and Divisional Policies and procedures.

1.  Ensures compliance with protocol and all regulatory policies, procedures 

and/or guidelines during clinical studies by training/guidance of investigators/ study coordinators, and follow-up of corrective actions.

2. Ensures validity of study by identifying/resolving discrepancies and obtaining missing data.

3. Contributes to developing and writing clinical protocols, case report forms, and other study aids for investigational products by addressing issues by interacting 

with appropriate personnel.

4. Maintains expertise in regulations for applicable geographies and types of studies (IDE, non-significant risk, feasibility, exempt, etc.).  Serves as a resource 

related to clinical trial regulations.

5. Serves as a mentor for new employees.

6. Serves as a trainer for contract research organizations (CROs) needed for additional monitoring support.

7. Ensures timely collection of study documentation by obtaining, maintaining and controlling all necessary records and documentation according to procedures 

and regulations.

Supervisory / Management Responsibilities

Work is supervised. Follows specific, detailed instructions.

Position Accountability / Scope

Begins establishing and cultivating a network of internal resources to facilitate completion of tasks. Individual influence is typically exerted at the peer level. 

Completes daily work to meet established schedule with guidance from 

supervisor on prioritization of tasks. May exercise authority within pre-established limits and approval.  Failure to achieve results can normally be 

overcome without serious effect on the business.

Minimum Education

Bachelor's degree and minimum of 2 years of related work experience with a 

good understanding of specified functional area, or an equivalent combination

of education and work experience.

Minimum Experience / Training

** Study coordinators with site management/activation experience a plus.

** RNs with hospital background a plus

** Research coordinators a plus

** Medical Device CRA experience required.

** Prefer cardio-vascular and/or structural heart experience

** CRA Certification preferred

** Experience with study start-up activities

** Experience with site activation highly preferred

Good knowledge and application of business concepts, procedures and  practices. Will perform this job in quality system environment. Failure to 

adequately perform tasks can result in noncompliance with governmental 

regulations. Learns to use professional concepts and company policies and procedures to solve routine problems. Works on problems of limited scope. 

Minimal independent decision making.

TRAVEL UP TO 20%

IN-HOUSE POSITION - NO REMOTE

OPEN TO CONSIDER CANDIDATES AT A LOWER LEVEL.
Job Family: Clinical Affairs / Statistics
Division: AVD Vascular
Travel: Yes, 20 % of the Time
Medical Surveillance: Yes
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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CRA II - Clinical Research Associate - Tendyne

Abbott
Saint Paul, MN

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Abbott
Saint Paul, MN
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