Research Assistant

3 days ago


Waterloo, Canada University of Waterloo Full time

Overview:
**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.**

**Responsibilities**:
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

Regulatory
- 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

Qualifications:

- 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 mínimal 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:
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.

Equity Statement:
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.

519-888-4567, ext. 45935
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