Project Manager (Randomized Clinical Trial)

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Posting End Date

Note: Applications will be accepted until 11:59 PM on the Posting End Date.

Job End Date

This position is expected to be filled by promotion/reassignment and is included here to inform you of its vacancy at the University.

This offer is conditional upon successful completion of a Criminal Record Check.

At UBC, we believe that attracting and sustaining a diverse workforce is key to the successful pursuit of excellence in research, innovation, and learning for all faculty, staff and students. Our commitment to employment equity helps achieve inclusion and fairness, brings rich diversity to UBC as a workplace, and creates the necessary conditions for a rewarding career.

Job Summary

CREST.BD is a globally recognized research network supporting people to live well with bipolar disorder (BD). Under the lead of Dr. Erin Michalak, the network's impact and reach has grown substantially, with multiple successful and ongoing research projects.

Since 2019, CREST.BD has been working on developing the PolarUs app (https://polarus.app/), the world's first BD self-management app specifically focused on optimizing quality of life (QoL). People with BD can experience good health and QoL, however, accessible, equitable and evidence-informed self-management interventions are required for this to occur. The PolarUs app offers one route to addressing this gap: the app features evidence-backed information tailored to BD, has been co-designed with people with BD and is now being culturally/linguistically adapted for diverse populations.

CREST.BD is now setting up a randomized control trial (RCT) to assess whether the PolarUs app significantly improves QoL outcomes in people living with BD. This three-year study will determine the efficacy of the PolarUs app in an enrolled cohort of patients diagnosed with BD in North America.

The project manager will be responsible for the setup and administration of the clinical trial. This will include overseeing advancement of the current version of the PolarUs app in three languages, French, Mandarin and Spanish, including enabling cultural adaptation of the app content in these linguistic groups.

Organizational Status

The Manager will report directly to the Principal Investigator, Dr. Erin Michalak, and will be directly involved in the supervision of research staff, WorkLearn students and volunteers.

Work Performed

● Create a digital content management system (CMS) for the PolarUs app to organize app information, 400+ resources and documentation - this will include scoping appropriate software, setting up a CMS database, creating training documentation and providing training to team members.

● Create a project management system for research activities related to the PolarUs app to ensure adherence to timelines and project goals - this will include identifying appropriate platform, , overseeing task assignments to team members, project planning activities, etc.

● Lead the establishment and oversee the running of three new advisory groups focusing on cultural and linguistic adaptation of the PolarUs app for French, Mandarin and Spanish speakers. This will include:

• Co-leading recruitment activities with the group chairs to ensure inclusion of diverse stakeholders within the advisory groups.
• Consulting and providing guidance on advisory group activities and administration, ensuring incorporation of EDI and cultural safety considerations.
• Provide guidance to group chairs in developing meeting agenda items (e.g., activities and discussions) in line with specific PolarUs research activities and needs

• Supervising and performance management of research assistants providing administrative support for advisory groups.

● Lead the planning, implementation and ongoing monitoring of the PolarUs app RCT study, including:

• Working with the principal investigators to design the RCT study to comply with clinical trial guidelines and best practices. This will include reviewing regulatory documentation published by federal agencies pertaining to medical devices (e.g., the United States Food and Drug Administration's Digital Health Policy Navigator) to ensure the PolarUs app and any research is compliant with regulations.

• Preparing and submitting ethics applications and amendments for the project to ensure project activities conform to UBC clinical research ethics board (CREB) guidelines and certifications.
• Leading the registration of the clinical trial in Canada and the United States through clinicaltrials.gov, in liaison with the UBC Office of Research Services, ensuring relevant documentation is prepared and submitted.
• The manager will be responsible for ensuring all data needed for analysis is collected through the study materials.
• Liaising with certified translation providers to ensure translation of RCT materials into the 3 target languages.
• In collaboration with the principal investigators, establish the trial's Data Monitoring and Safety Committee, including recruiting and managing trial outcome raters.
• Oversee trial administration activities, including supervising staff involved in enrolling study subjects and conducting study visits. Regular review of collected data will be required to ensure accuracy and feasibility, including tracking of participant progress to ensure compliance with trial goals and requirements.

• In collaboration with the lead mobile software developer, create and manage the data analytics platform for PolarUs - this will require translation of research study requirements into a data analytics approach to ensure appropriate and accurate data is collected.

● Support integrated knowledge translation (iKT) activities related to CREST.BD projects. This will include contributing to peer-reviewed publications for mood disorder and digital health journals, managing training and use of iKT tools such as the Tapestry Tool (https://www.home.tapestry-tool.com/), and supporting peer researchers in knowledge exchange activities (e.g., blogging, contributing to project publications).

● Provide grant management support, including:

• Contributing to preparation of grant applications, including reviewing and drafting applications and relevant documentation.
• Completing grant monitoring and evaluation documents such as progress reports and end-of-grant reports.
• Providing internal planning support to meet submission deadlines
• Identifying relevant funding opportunities, and building and maintaining relationships with funders
• Supporting preparation, submission and management of financial/budget information related to grants.

● Create and manage documentation pertaining to licensing requests related to the PolarUs app (e.g., use of language translations of the Quality of Life in Bipolar Disorder scale in other clinical trials).

● Lead recruitment of volunteers, WorkLearn students and research assistants.

● Act as the first point of contact for volunteers, WorkLearn students and research assistants, exercising personal judgment in the event of any queries or unforeseen problems. The manager will be responsible for assigning tasks, monitoring progress and providing feedback to staff.

● Respond to enquiries from team members, trainees, collaborators and supporting university departments (e.g., Finance, HR, etc.) with minimal supervision.

Consequence Of Error/Judgement

The position must exercise a significant amount of independent judgment, responsibility and initiative in determining work procedures and methods, and coordinating work on the project. Errors made in this position can impede the progress of the project and cause adverse relationships with partners, decision makers, and funding agencies and may compromise the positive promotion of the project. Errors or incorrect decisions could potentially result in delays in completing the project or seriously compromise the quality of the research.

Supervision Received

Reports directly to the Principal Investigator with minimal daily supervision. Performance is assessed based on the achievement of project objectives and goals. Works with the Principal Investigator in the development of short- and long-term goals for the project.

Supervision Given

Provides direct supervision to two or more research assistants, WorkLearn students and volunteers.

Minimum Qualifications

- Undergraduate degree in a relevant discipline. Minimum four years of related experience, or the equivalent combination of education and experience.

- Willingness to respect diverse perspectives, including perspectives in conflict with one's own

- Demonstrates a commitment to enhancing one's own awareness, knowledge, and skills related to equity, diversity, and inclusion.

Preferred Qualifications

● Postgraduate qualification or Masters' degree in Health or Social Sciences would be desirable.

● Recent related experience in research management or project coordination, including using project management software or comparable enterprise information systems, is preferred.

● Familiarity with Google Analytics, BigQuery and other big data management softwarewould be desirable.

● Some experience with Python or R coding languages for data cleanup and analysis would be desirable.

● Familiarity with survey data collection software such as Qualtrics would be desirable.

● Expertise with quantitative and qualitative data analysis using SPSS, NVivo and/or comparable software is required.

● Demonstrated ability to both maximize the utility of digital software and assist, explain and coach others in such systems.

● Knowledge and expertise in mental health research is essential. Knowledge of community-based participatory research methods is desirable.

● Knowledge of research design and methodology (especially RCTs), including submission of clinical research ethics boards applications and relevant documentation, is essential.

● Previous research experience within an RCT would be an asset.

● Training and experience in creating and managing community advisory groups or focus groups would be beneficial.

● Expertise in generating diverse knowledge translation (KT) outputs, inclusion of lived experience perspectives and plain language writing skills will be desirable.

● Previous experience with providing grant management support, such as drafting of grant applications, is essential.

● Advanced skills in word-processing, spreadsheets, and databases (i.e. Microsoft Office, Google Suite, etc.) are essential.

● Demonstrated ability to exercise a high level of tact, discretion and sensitivity.

● Demonstrated excellence in oral and written communication, as well as excellent content writing and research skills.

● Effective organizational skills and ability to be thorough, accurate, and have a high level of attention to detail are essential.

● Excellent interpersonal skills with proficiency in inter-professional communication and intercultural communication with various interest-holders.

● Experience in supporting Equity, Diversity and Inclusion (EDI) considerations in health research is desirable.

● Ability to assign, train, and supervise the work of others.

● Self-motivated and self-directed.

● Excellent organizational skills and the ability to work within deadlines in a fast-paced environment.

● Professional working proficiency in French, Mandarin and/or Spanish would be an asset.