|Job Category||Professional Consulting|
|Application Deadline||June 30, 2021|
|Experience Required||5+ years|
|Job Duration||1 year|
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.
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.
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.
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).
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).
Excellent Communications skills, both oral and written.
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.
Advanced English Oral/Written.
Intermediate MS Office, SAS JMP.
If you are interested in this role, please contact
Only those who are qualified for the role will be contacted