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Job Details


Abbott

Clinical Research Associate (31032466)

Pharmaceuticals

All

Yearly

Full Time

No

Abbott Park, Illinois, United States

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 113,000 colleagues serve people in more than 160 countries.

MAIN PURPOSE OF ROLE

  • Experienced professional individual contributor that works under limited supervision.
  • Applies subject matter knowledge in the area of Medical Affairs.
  • Requires capacity to apply skills/knowledge within the context of specific needs or requirements.

MAIN RESPONSIBILITIES
As the Experienced professional in the Medical Affairs Sub-Function, possesses well developed skills in overseeing the direction, planning, execution, clinical trials/research and the data collection activities.

• Contributes to implementation of clinical protocols and facilitates completion of final reports.

• Recruits clinical investigators and negotiates study design and costs.

• Responsible for directing human clinical trials, phases III & IV for company products under development.

• Participates in adverse event reporting and safety responsibilities monitoring.

• Coordinates and provides reporting information for reports submitted to the regulatory agencies.

• Monitors adherence to protocols and determines study completion.

• Coordinates and oversees investigator initiations and group studies.

• May participate in adverse event reporting and safety responsibilities monitoring.

• May act as consultant/liaison with other corporations when working under licensing agreements.

Travel: up to 20% with potential to travel internationally, e.g. Ireland. (Potentially, up to 2 to 3 trips per month.)

EDUCATION AND EXPERIENCE YOU’LL BRING

Required:

  • Bachelor’s degree B.S in biological sciences or medical specialty preferred.
  • Minimum 3 years of clinical related experience

PREFERRED / IDEAL EXPERIENCE, EDUCATION, ETC.:

  • Knowledge of regulations and standards (GCP) affecting IVDs and Biologics
  • Clinical Laboratory certification (MT, ATCP or equivalent) or certification as a clinical research associate (CCRA)
  • Site monitoring of investigational drug or device trials or clinical laboratory assay/instrument experience
  • Demonstrates good basic writing and presentation skills (i.e. clear, concise, effective and well organized)