Term: 14 Months
This position is primarily responsible for the management, distribution and accountability of the study products used by study participants of the Centre for Ocular Research and Education (CORE). The incumbent must educate study participants on the proper use of assigned products according to protocol requirements. This position is contingent upon funding.
This position is contingent on funding.
Management of Study Products
Acquire study products and study consumables
Maintain inventory control and entry of product information into appropriate databases
Liaise with CORE financial department to ensure study product costs are allocated appropriately
Manage study product accountability throughout study
Reconcile study products at end of each study
Dispose of study products according to study protocol and appropriate UW guidelines
Distribution of Study Products
Dispense study products according to approved randomization schedule
Instruct study participants on the use and care of study products
Manage the dispensing and returning of study products for each study as per protocol requirements
Produce and maintain Standard Operating Procedures (SOPs), Work Instructions (WI) and TOOLS for management of study products according to regulatory guidelines
Train other team members in the use of regulatory documents and ensure implementation
Communication with Study Sponsors
Ensure all study product information is up-to-date and available for review by study monitors
Meet with study monitors during scheduled visits to review accountability procedures and verify records
Liaise with study sponsors as needed regarding study product matters
Contribute to regular sponsor meetings and study progress reports
Participate as a member of the study team representing CORE at both on-site and off-site training meetings organized by study sponsors as required
Provide masked study product assignment information as required, e.g., for adverse event reports.
Management of Clinical Studies Conducted Remotely
Develop presentations and train external sites on the management and accountability of study products.
Create forms for study product accountability for each external site
Coordinate and distribute all study related documents and supplies to external sites
Manage flow of data from the external sites to the CORE Data Management Team ensuring accuracy and completeness of data
High school diploma or equivalent. Optometric Assistant certification or equivalent training would be preferred, and a Certified Research Associate Designation would be an asset
At least 3 years’ experience in a vision or health care setting is preferred
Knowledge of optometric terminology and vision care is a definite asset
Experience in regulatory affairs and compliance is an asset
Demonstrated ability to operate with a high degree of confidentiality using discretionary judgment and excellent problem-solving skills
Excellent oral and written communication skills with the ability to present detailed instructions and information in a clear, concise manner
Demonstrated ability to take initiative in a fast-paced environment with multiple deadlines and conflicting requests
Excellent organizational and interpersonal skills with exceptional attention to detail.
Proven ability to work with minimal supervision.
Knowledge of Microsoft Office suite and the willingness to become proficient in the use of in-house databases as required
This position potentially requires occasional travel
Vaccination Requirement Statement:
Effective May 1, 2022, the University suspended its Vaccination Requirement. Prior to May 1, pursuant to this Requirement, all University employees were required to submit proof of full vaccination against COVID-19 (subject to the University’s obligations under the Human Rights Code to accommodate employees who were unable to receive a vaccination). The University’s Vaccination Requirement website can be found here: https://uwaterloo.ca/coronavirus/return/vaccination-requirement.
The pandemic is ongoing and public health advice continues to evolve. Accordingly, the University reserves the absolute right to reinstate the Vaccination Requirement on short notice, and upon such reinstatement you will be required to comply. You shall also be required to comply with any new health and safety policies/requirements implemented by the University from time to time, including new policies/requirements related to mandatory employee vaccination. As the University may need to reinstate the Requirement on short notice, it will continue to collect and maintain up-to-date information on employee vaccination status. Please submit your Covid-19 vaccine status (QR code) to: https://checkin.uwaterloo.ca/
Failure to comply with the Vaccination Requirement if it is reinstated, including failure to comply with any future amendments to the Vaccination Requirement, or failure to comply with new health and safety policies/requirements implemented by the University, including those related to new mandatory employee vaccination, shall result in discipline up to and including termination of employment.
The requirement to be vaccinated, if reinstated, will be subject to the duty to accommodate pursuant to the Human Rights Code. If you are unable to be vaccinated for reasons related to a ground protected under the Human Rights Code, you may submit a written request for accommodation with an explanation of the reasons and/or any supporting documentation. If you request accommodation, the University may follow up with you for further information if necessary.
The University of Waterloo is committed to implementing the Calls to Action framed by the Truth and Reconciliation Commission. We acknowledge that we live and work on the traditional territory of the Neutral, Anishinaabeg and Haudenosaunee peoples. The University of Waterloo is situated on the Haldimand Tract, the land granted to the Six Nations that includes six miles on each side of the Grand River.
The University values the diverse and intersectional identities of its students, faculty, and staff. The University regards equity and diversity as an integral part of academic excellence and is committed to accessibility for all employees. The University of Waterloo seeks applicants who embrace our values of equity, anti-racism and inclusion. As such, we encourage applications from candidates who have been historically disadvantaged and marginalized, including applicants who identify as First Nations, Métis and/or Inuit/Inuk, Black, racialized, a person with a disability, women and/or 2SLGBTQ+.
All qualified candidates are encouraged to apply; however, Canadians and permanent residents will be given priority.
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