Senior Clinical Research Associate

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Adecco is currently hiring for a Clinical Research Associate - Senior for our Medical Manufacturing client in Ottawa West. This is a permanent opportunity offering full time hours, Monday – Friday. The salary for this position will be determined based on education and experience. 

To qualify for this role, you must have a minimum 7 years working in a Clinical Research position. The individual must be flexible and be able to work in a fast-paced environment with changing priorities. 

Our client is a diversified health care innovator with a legacy of pioneering work in medical diagnostics and devices. They are dedicated to advancing innovative with-patient diagnostic technology to improve patient care and system efficiency by fundamentally changing the way health care professionals process patients through their system.  

Clinical Research Associate - Senior 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.
  • To be considered for this Clinical Research Associate - Senior opportunity in Ottawa West, please Apply Now!

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    Reference number CA_EN_1_021956_1752505

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