Term: 1 Year
This position supports research conducted in the Centre for Ocular Research & Education (CORE) in several key areas. It assists with the recruiting and scheduling of study participants and is responsible for managing the study regulatory documentation.
This position is contingent upon funding.
Study Participant Recruitment
Develops recruitment strategies and required documents, including study-specific promotional material and advertising, in accordance with research ethics standards
Establishes contact with potential study participants and directs them toward the appropriate study
Advises Lead Investigator on the availability of potential study participants, monitors database for gaps in participant demographics and assists with the development of outreach and marketing strategies to address upcoming recruitment needs
Documents recruitment activities and results for individual studies and evaluates the success of different approaches to inform future recruitment strategies
Provides support for outreach events for the public and local optometrists
Maintains the CORE pre-screening study participant database by inputting and updating information and querying the database to match potential participant characteristics with study inclusion criteria
Study Participant Interaction
Schedules study participant appointments and required resources such as research personnel, space and equipment according to specific protocol requirements for each study
Sends appointment reminders and related instructions to study participants and receives them on arrival for their appointment
Witnesses the informed consent process for study participants
Assists with the reimbursement of study participants which includes preparing and signing cheques to a maximum of $299.00 per study participant as well as the distribution of gift cards as per policy dictated by the UW Finance department
Dispenses parking reimbursements for study participants
Management of Site File/Trial Master File
Maintains records of employee regulatory training and documentation
Liaises with new employees regarding training and documentation requirements
Each January ensures CORE employees provide an updated Curriculum Vitae, and Financial Disclosure form
Ensures all renewable trainings are retaken as required (e.g., Good Clinical Practice, Good Laboratory Practice etc.)
Ensures all Sponsor required training is completed and certificates collected, as required
Maintains an electronic record of all required regulatory documentation and training
As required, creates a Site File (SF) or Trial Master File (TMF) for each clinical research study and ensures that it is populated and updated with all required documentation over the life of the study
Ensures that all required signatures in each SF/TMF have been collected
Maintains communication with study sponsor to ensure the documentation in their Trial Master File is up-to-date and consistent with the CORE Site File
Updates CORE study personnel of changes to Case Report Forms, Informed Consent Letters, protocol and ethics approval for each study, as required
Scans all documents in each SF/TMF to a designated electronic folder
Supports study lead investigators with monitor/auditor preparation.
Applies for and obtains insurance certificates for each clinical study sponsor. Applies for renewal of each certificate yearly in early December
After study completion, conducts an archiving review of all study documents to ensure completeness. Compiles all elements of the SF/TMF (including investigational product documentation, Health Canada applications, and data management documents), along with source documents/CRFs, for offsite storage at Iron Mountain
A high school diploma or an equivalent combination of education and experience is required.
A minimum of 3 years’ experience in an administrative role requiring well developed organizational and time management skills is required
Experience working in a health care or clinical research setting is an asset
Excellent communication (oral and written English) and customer service skills are required
Must be detail oriented
Strong organizational and time management skills are essential
Must be able to manage a high volume of work with conflicting priorities and deadlines
Ability to exercise judgement and discretion when handling confidential information is required
Knowledge of Microsoft Office is required
Familiarity with generating content, including use of graphic design software, and managing social media platforms, particularly on Facebook, Twitter, Instagram and LinkedIn is an asset
Knowledge in advertising and interest in community outreach is an asset
The incumbent will be required to multi-task and prioritize requests
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.
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