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Sr. Clinical Research Associate, Abbott Point Of Care (ottawa/Remote)

February 11 2021
Categories Clinical research, Pharma, Biotech, Sciences, R&D, Research and development
Ottawa, ON

At Abbott, we're committed to helping you live your best possible life through the power of health. For more than 130 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, 109,000 of us are working to help people live not just longer, but better, in the more than 160 countries we serve.

Abbott Point of Care is a worldwide leader in providing with-patient care solutions that are intuitive, reliable, and cost-effective for our customers. By delivering lab-quality results in minutes, our i-STAT® System family of with-patient products and services fosters a collaborative, patient-centered environment while driving operational performance. We are headquartered in Princeton, New Jersey, with more than 1,500 global employees and a presence in 84 countries. Our 46,500 square meter, state-of-the-art manufacturing facility, Abbott Point of Care, is located in Ottawa, Ontario, Canada.

Status: Full time/Permanent

Responsibilities:

  • 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 and may track core lab activities and more complex components of the trial.

  • 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.

  • May mentor and train 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 and regulations.

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

  • Responsible for implementing the strategic initiatives established by the business and the department.

  • Responsible for tactical components of creating and driving customer-centric relationships cross-functionally to support product developments throughout the product(s) life cycle.

  • Subject matter expert (SME) in the technical application of product portfolio.

  • Execution of all aspects of testing including design, developing test materials, protocols, evaluation of test data, and all around support of analysis. Responsible for the execution of all aspects of clinical studies including but not limited to: site selection, pre-study visits, essential document review, site close-outs.

  • Other miscellaneous duties as may be required.

Education and Experience:

  • Require minimum 7 years relevant work experience or exposure to a technical / clinical environment, laboratory instrumentation and / or medical diagnostic testing.

  • Knowledge of lab practices or point of care testing environments, regulations and standards affecting medical diagnostics, lab practices, familiarity with statistics and statistical software (desired).

  • Bachelor's degree or equivalent experience required; prefer background in the sciences or a medically-related area (such as but not limited to Biology, Chemistry, Nursing, Medical Technology, Respiratory Therapy or related field of study).

  • Excellent Communications skills, both oral and written.

  • Ability to initiate, plan and manage projects.

  • Strong decision-making skills and ability to prioritize.

  • Understands International Harmonized /Committee Good Clinical Practices, IHC/GCP.

  • Good Manufacturing Practice 21 CFR Part 820 is an asset.

  • Knowledge of project management tools and techniques.

  • Broad knowledge and application of business concepts, procedures and practices.

  • Advanced English Oral/Written.

  • Intermediate MS Office, SAS JMP.

  • Travel up to 30% of the time domestically and / or internationally may be required.

Abbott Canada is committed to the hiring, advancement and fair treatment of individuals without discrimination based on factors such as race, sex, colour, ethnic or national origin, religion, disability, age, citizenship, family or marital status, political beliefs, sexual preference or other factors included in human rights legislation.

Our diversity goals for recruitment, hiring, and retention are embedded in our corporate goals, and our diversity initiatives are supported by the highest level of the organization.

We strongly believe that a diverse workforce fosters more creative and innovative thinking throughout the organization. Creating an inclusive environment, where everyone is respected and valued, enables us to leverage our diversity as a business driver and strengthens our position as a global leader.

Abbott strives to promote and maintain an inclusive, high-performing culture that allows all employees to reach their full potential and contribute to Abbott’s success.

Join Our Talent Community to learn about upcoming job opportunities or connect with us at Abbott Canada, on LinkedIN, on Facebook and on Twitter @AbbottNews and @Abbott Global.

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