Clinical Study Regulatory Assistant CSRA

Union :  NonUnion

Site :   Princess Margaret Cancer Centre

Department :   Division of Medical Oncology and Hematology Clinical Trials Group

Reports to :    Clinical Research Manager DMOHCTG

Work Model :  OnSite

Grade :   N0 : 03

Hours :   37.5 hours per week

Salary : $52182  to $65228 Annually (To commensurate with experience and consistent with UHN compensation policy)

Shifts :   Monday Friday

Status :   Permanent Full Time

Closing Date : Until Filled

The Division of Medical Oncology and Hematology University Health Network requires Clinical Research Study Assistant to work with its oncology and hematology clinical trial portfolio. This division runs a broad spectrum of therapeutic trials across all types of malignant disease. The Clinical Research Study Assistant will provide administrative and regulatory support to the clinical research staff of the DMOH Clinical Trials Group. Principle responsibilities include supporting the clinical research staff with preparation of the

submissions to the Research Ethics Board and Health Canada maintenance of regulatory binders and study documentation some data entry tasks and other departmental administrative tasks. The Clinical Trials Group operates in accordance with the

trial protocol hospital and departmental guidelines and professional standards of practice. Data is assessed compiled recorded and submitted to cooperative groups and / or pharmaceutical companies or used for internal PMH studies. All data must be

complete accurate timely and must be in compliance with applicable ICHGCP FDA and US federal code and TriCouncil regulations. The Clinical Research Study Assistant must be able to interpret the applicable regulations in order to ensure compliance. Quality assurance procedures are utilized to ensure high quality data is obtained.

Duties

• Assists the interprofessional clinical research team in performing studyspecific tasks as per protocol
• Responsible for data collection entry verification and reporting
• Enters medical data from health records or other sources as per approved study protocol and authorized access into electronic data capture (EDC) systems for example Redcap Medidata etc.
• Identifies and logs protocol and SOP deviations
• Supports resolution of data queries from sponsors and issues query forms to study team or third parties
• Supports the reporting of events to Research Ethics Board as needed(Privacy incidents and Serious Adverse Events (SAE))
• Prepares submissions (amendments reportable events annual renewals study closures) to Research Ethics Board (REB)
• Executes studyrelated administrative tasks such as collection and maintenance of regulatory documents ethics submissions protocols staff training and delegation logs in paper and electronic formats
• Maintenance & modification of studyspecific trackers and study tools (screening and enrollment worksheets eligibility checklists)
• Scheduling onsite / virtual monitoring visits and collecting necessary source documentation for data verification
• Liaises between site and sponsor to ensure that all trialrelated documentation and information are distributed to relevant staff involved with the trial
• Ensures and maintains regulatory compliance for clinical research studies involving human subjects by following appropriate protocols
• Coordinates the closeout phase of clinical study protocols as well as archival of study documents.

Qualifications :

Additional Information :

Why join UHN

In addition to working alongside some of the most talented and inspiring healthcare professionals in the world UHN offers a wide range of benefits programs and perks. It is the comprehensiveness of these offerings that makes it a differentiating factor allowing you to find value where it matters most to you now and throughout your career at UHN.

Current UHN employees must have successfully completed their probationary period have a good employee record along with satisfactory attendance in accordance with UHNs attendance management program to be eligible for consideration.

All applications must be submitted before the posting close date.

UHN uses email to communicate with selected candidates.  Please ensure you check your email regularly.

Please be advised that a Criminal Record Check may be required of the successful candidate. Should it be determined that any information provided by a candidate be misleading inaccurate or incorrect UHN reserves the right to discontinue with the consideration of their application.

UHN is an equal opportunity employer committed to an inclusive recruitment process and workplace. Requests for accommodation can be made at any stage of the recruitment process. Applicants need to make their requirements known.

We thank all applicants for their interest however only those selected for further consideration will be contacted.

Remote Work : Employment Type :

Fulltime