The Clinical Research Data Manager (CRDM) is responsible for research data management (RDM) activities involving the design, administration, data collection, validation and testing for CCI clinical trials and registries. The individual will be responsible for planning and collecting data from clinical trials and ensures that data collected is accurate and grouped properly, solve any operational problems, and prepare statistical reports.

Organizational Status
The CRDM will report to the CCI Director of Research Operations. Will work closely with other staff to fulfill the operational requirements of the research group.

Work Performed       

• Serve as the Lead Research Data Manager on multiple clinical research studies
• Reviews research protocols to provide data collection related feedback
• Develops a Data Management Plan (DMP) and a Data Validation Edit Check Plan for each trial
• Collaborates with CCI team members on data transfers, data cleaning, creating and analyzing large datasets and other data management issues relevant to research
• Develop database (DB) clinical trial data specifications, including eCRF design, user requirements, edit rules/checks, query logic and data validations.
• Develops and refines project DM documentations (DMP, Data Validation Plans etc.) based on good RDM practices
• Develop Case Report Form (CRF), electronic and/or paper in consultation with Clinical Study Coordinator
• Create standards in CRF setup and edit checks to ensure consistency and efficiency in database development
• Participates in the review of Clinical research documents (e g. Protocols, Case Report Forms, Reports and Statistical analysis) and provides guidance on RDM practices
• Develop standard procedures/reports to validate clinical trial data to ensure consistency, integrity and accuracy based on project specific guidelines
• Query data inconsistencies and revise case report forms in compliance with standard operating procedures and up to date research data management systems
• Extract and monitor the trial data to identify issues
• Participates in the preparation and presentation of research data, when applicable.
• Ensures data system compliance by following the established guidelines of national and international regulatory authorities.
• Mentor or train other junior members

Supervision Received
Work closely with PI and CCI Study Coordinator.  Work with general direction and supervision from the PI/Director, Research Operations as part of a collaborative team. This individual will be expected to work independently in accordance with established objectives; and exercise initiative and judgment in performing all work-related function.

Supervision Given     
Provide mentorship to new or inexperienced research staff.

Consequence of Error/Judgement
Errors in the management of data could result in inaccurate data sets, inadequately analyzed data, as well as the loss of productivity for the investigators and the potential loss of grant or other research funding.

Lack of careful attention to regulatory guidelines and approvals could suspend Investigator/physician and hospital/University as a site for further clinical research and/or funding. The performance of clinical trials and research projects must strictly conform to appropriate regulations:
1) personal: maintaining professional behavior and respect for subjects and staff
2) local: the UBC Clinical Research Ethics Board
3) Provincial: B.C. Privacy Act
4) Federal: Health Canada, International Conference on Harmonization, Tri-Council Policy Statement, Good Clinical Practice and
5) International: U.S. Food & Drug Administration.

Qualifications

• Bachelor’s degree, or recognized equivalent, in Computer Science, Mathematics or Statistics.
• Minimum 3 years of clinical research data management experience in a health-related setting.
• Experience with clinical data collection, monitoring/auditing as well as clinical trial documentation using Electronic Data Capture systems is required
• Experience using Database Management systems such as, iDataFax/ DFDiscover and RedCap preferred.
• Knowledge and experience in statistical software SAS and other relevant software platforms such as Oracle InForm, PL/SQL, Visio is required.
• Knowledge of ICH/GCP guidelines
• Excellent project management skills
• Strong analytical and problem-solving skills
• Demonstrated ability to express complex technical concepts effectively
• Mentor/training experience
• Strong verbal and written communication skills
• Exceptional organizational skills and customer relations
• Excellent problem recognition and problem-solving abilities
• Excellent listening, conflict resolution skills
• Client service oriented, with the ability to effectively work with diversity

Equity and diversity are essential to academic excellence.  An open and diverse community fosters the inclusion of voices that have been underrepresented or discouraged.  We encourage applications from members of groups that have been marginalized on any grounds enumerated under the B.C. Human Rights Code, including sex, sexual orientation, gender identity or expression, racialization, disability, political belief, religion, marital or family status, age, and/or status as a First Nation, Metis, Inuit, or Indigenous person.

All qualified candidates are encouraged to apply; however, Canadians and permanent residents will be given priority.

UBC Off-Campus Hospital Sites

Staff – Non Union

Job Category
M&P – AAPS

Job Profile
AAPS Salaried – Research and Facilitation, Level B

Job Title
Clinical Research Data Manager

Department
Wood Laboratory Division of Cardiology | Department of Medicine | Faculty of Medicine

Compensation Range
$5,468.83 – $7,878.17 CAD Monthly

Posting End Date
July 13, 2021 Note: Applications will be accepted until 11:59 PM on the day prior to the Posting End Date above.

Job End Date
Jul 15, 2022

Or send an email with cover letter and CV to nicole.carbert@ubc.ca

ROLE: UBC Medical Undergraduate FLEX (Flexible and Enhanced Learning) Block Opportunity

That Cardiovascular Translational Laboratory is seeking students interested in participating in the UBC Medi UBC Medical Undergraduate FLEX (Flexible and Enhanced Learning) Block Opportunity within in the lab’s research program.

OPPORTUNITY SUMMARY

The Cardiovascular Translational Laboratory is located at the UBC Centre for Heart Lung Innovation (HLI) at St. Paul’s Hospital. The lab is co-lead by Dr. Stephanie Sellers (vascular biologist) and Dr. Janar Sathananthan (interventional cardiologist) and actively partners with HLI, the Centre for Cardiovascular Innovation, the Centre for Heart Valve Innovation, industry, and international academic labs to bring together a multi-disciplinary group of investigators.

The lab’s research program includes on-going projects in the areas of cardiovascular imaging, coronary artery disease, heart failure, aneurysm, and microvascular disease. However, the primary focus of the lab is valvular heart disease and bioprosthetic heart valves. Investigations in the lab span from cellular/molecular work, ex-vivo / in-vitro / in-silico modeling, and clinical investigation.

Students interested in the lab should contact ssellers@providencehealth.bc.ca and
jsathananthan@providencehealth.bc.ca

The Cardiac CT Core Laboratory at St. Paul’s Hospital is looking for a Master of Science student to join our team and conduct research in the field of Cardiac Computed Tomography (CT) for Transcatheter Heart Valve Therapies.

The successful candidate will work full-time under the supervision of Dr. Philipp Blanke, Cardiac Radiologist at St. Paul’s Hospital and Assistant Professor at the UBC Department of Radiology, Faculty of Medicine and affiliated with the UBC Experimental Medicine Program (ExMED).

The Cardiac CT Core Laboratory’s research is focused on cardiac CT imaging for procedural planning and optimization of transcatheter heart valve repair and replacement, post-procedural imaging and valve thrombosis as well as artificial intelligence for structural heart CT imaging. The laboratory supports external clinical trials as well as patient centered research on the local patient population at St. Paul’s Hospital. Clinical trials range from First-in-Human and Early Feasibility Studies to large, multicenter, randomized clinical trials, while employing in-house developed imaging and analysis concepts.

The successful candidate will receive intensive training in cardiac CT analysis and will have the opportunity to employ and further develop state-of-the-art imaging concepts on local patient cohorts as well as multi-center trials.

The candidate should

• hold an undergraduate degree in Health/Lifesciences, Biomedical Engineering or a related field
• have strong analytical and problem-solving skills
• be proficient in English with excellent interpersonal and communication skills
• be self-motivated, independent, and organized worker

Site: St Paul’s Hospital, Vancouver, Canada
Duration: 2 years

This is a 2 year fellowship that will focus on advanced echocardiography in structural intervention, in conjunction with advanced cardiac CT and MRI assessment of structural intervention. The echocardiography component will include preprocedural assessment, intraprocedural guidance of structural intervention and post procedural assessment following transcatheter intervention. Extensive experience in cardiac CT and MRI in the evaluation of structural intervention will also be included in this fellowship. St Paul’s Hospital is a large tertiary hospital where a number of transcatheter interventions are performed routinely including MitraClip, TriClip and novel transcatheter valve interventions (Edwards M3, Evoque). Other procedures routinely performed at our centre include paravalvular leak closure and ASD closures. Clinical responsibilities during the fellowship will also involve engagement in multidisciplinary transcatheter heart rounds and the structural heart clinic. The successful candidate will be expected to be involved in structural research and will be expected to publish at least one original work as well contribute to other research during the two year fellowship.

Fellowship start date: July 1, 2023.
Application deadline: July 30, 2021.

Applications should include an updated CV, cover letter detailing intent and career goals, and 2 letters of recommendation. Contact details of the 2 referees should also be provided. Applications should be directed to gsathananthan@providencehealth.bc.ca.