Abbott CRA II - Clinical Research Associate - Tendyne in St. Paul, 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.
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.
- 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.
Ensures validity of study by identifying/resolving discrepancies and obtaining missing data.
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.
- 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.
Serves as a mentor for new employees.
Serves as a trainer for contract research organizations (CROs) needed for additional monitoring support.
Ensures timely collection of study documentation by obtaining, maintaining and controlling all necessary records and documentation according to procedures
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.
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 10%
IN-HOUSE POSITION - NO REMOTE
OPEN TO CONSIDER CANDIDATES AT A LOWER LEVEL.
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 email@example.com