Position Summary:

The Research Coordinator will be responsible for the administration of two or more active research projects. Of the two main projects, one project is entitled "Feasibility of Egg White Pudding Supplementation for Individuals in Hospital Needing Dietary Supplementation", and the other project is entitled "Evaluation of a plant-based protein pudding in older adults attending a medically managed fitness facility".

The scope of duties includes study initiation activities including obtaining ethical and institutional approvals (including Research Ethics Board, site impact, and Health Canada submissions) and they will also maintain on-going submissions including amendments and annual approval as required. Additional duties include study budget review, as well as study implementation activities including recruiting participants, obtaining informed consent, performing data audits, conducting study visits, data collection, entry, and conducting follow-up sessions with participants with chronic disease who are part of various clinical research studies. They will also be responsible for providing dietary instruction for clinical trials involving nutritional interventions. The research coordinator will lead the coordination of surveys, program evaluations and chart reviews in accordance with the research ethics board approved protocol, and ICH-GCP, and TCPS2: CORE guidelines.

The Research Coordinator will also help to liaise with key partner organizations and personnel and will provide data informed decisions for program enhancement, and will lead the development (i.e., writing), organization and implementation of various research protocols. They will also assist with grant applications and knowledge translation activities including manuscripts, conference presentations, and infographics. Other duties as assigned. The incumbent will provide updates on study progress to the Research Manager, Principal Investigator, and Project Manager on a regular basis.

Qualifications and Competencies:

Education:

Completed graduate degree (MSc or higher) in a related discipline.
Minimum 2 years research experience

Experience:

Previous research experience is required, including obtaining informed consent, participant recruitment, patient visits, data collection and data management activities is required.
Previous clinical research experience in Health Canada or FDA regulated trials is a strong asset.
Previous experience conducting research that assess a nutritional intervention is required.
Previous experience working with patients with chronic kidney disease is a strong asset.
Previous experience conducting research in a clinical setting is considered a strong asset.
Proficient in Microsoft Office programs including Microsoft, Excel, Power Point, and Word.
Experience with preparing institutional impact, regulatory board, Health Canada Submissions, and privacy and data access applications is required.
Completion of ICH-GCP, Health Canada Division 5, TCPS2-CORE, and PHIA training is required.

Skills and Abilities

Strong interpersonal skills and ability to work within a team-oriented environment
Effective oral and written communication skills
Must be able to work independently and with limited supervision.
Excellent organization and time management skills. Ability to follow oral and written instructions.

Contacts and Relationships

Ability to establish and maintain collaborative working relationships with various levels of front-line clinical staff and other research staff, including management.
Expertise in liaising with funders, clients and partner organizations to assist the Clinical Research Associate with budget and contract review.

Duties and Responsibilities:

1. Leads the implementation of various protocols at partner institutions from inception to completion, including protocol writing and development, protocol implementation, and assists in making recommendations for program improvement.

2. Recruitment of participants into research studies including obtaining informed consent, coordinating research appointments and visits to study site laboratories, and conducting study assessments. Study assessments may include the administration of questionnaires, physical and cognitive function tests, as well as other project specific exams, as required.

3. Study data management, including collecting and recording clinical data from patients or medical records, entering data into a study database and performing periodic audits of data accuracy as stipulated in the protocol or manual, assuring proper storage of study documents (electronic or otherwise) to protect participant confidentiality and privacy.

Project management of single-site and multi-site research studies including overseeing study set-up, reviewing and developing budgets, protocol updates and modifications, project planning resources, developing standard operating procedures and training materials, coordination of patient remuneration and focus groups, and general protocol implementation.
Preparation and submission of research ethics board applications (including amendments), and other institutional review boards, as required.
Preparation and submission of Health Canada applications; and applications for bringing nutritional products to market.
Attendance at team meetings and communication with senior management, project leads, academic and industry partners and front-line clinical staff.

8. Prepares, edits and reviews and submits reports, manuscripts and presentations.

9. Assists with training of new project team members.

10. Providing dietary instructions to participants based on study protocols, including counselling participants on proper food storage, providing nutritional guidance to participants, and creating nutrition educational materials tailored for participants

11. Assisting with inspections and audits related to research studies (e.g. Health Canada inspections)

Other duties as assigned.

Overview of Position (Position and Project Dependent):

1. Study oversight, coordination, and management

This will include the overall coordination and set-up activities including completing feasibility assessments, budgetary review, as well as oversight of research studies such as liaising with local healthcare departments or organizations (i.e., Seven Oaks Hospital Pharmacy, Shared Health Diagnostic Services) and other national and international co-investigators/collaborators and participating sites. Additional tasks may include developing operating policies and procedures, establishing data collection forms, training other coordinators on study procedures and other duties as assigned. Study management duties include protocol updates and modifications, planning project resources, coordination of patient remuneration and focus groups.

2. Recruitment and screening of eligible participants into research studies and running participants through research related activities

Recruitment and screening of participants into research studies in accordance with ethical research guidelines and appropriate clinical research practices. This will include the maintenance of a study log. The research coordinator may be requested to travel to other clinics or sites in Winnipeg, including but not limited to the Health Sciences Centre and St. Boniface Hospital in order to recruit and obtain consent, and data from a designated number of research participants.

3. Preparation and submission to various Institutional Review Boards (IRB) (eg. Research Ethics Board and Hospital Resource Utilization Committees), oversight committees (i.e., Health Canada for clinical trials)

This is done in order to obtain the necessary approvals from various institutions to conduct ethical research. This may occur multiple times per year depending on how many projects are assigned by the senior management team. The research coordinator must also be prepared to assist with inspections and audits related to research studies (e.g. Health Canada inspections).

4. Communication with Health Care Staff, Study Participants and Patient Partners

Communication with health care staff in areas where the study is being conducted. This will include coordinating in-services for staff on the objectives and impact of the research study being conducted both locally and nationally. Communication with study participants to schedule assessments, study sessions, and disseminate study results. Communication, engagement and scheduling of meetings with patient partners, if applicable.

5. Preparation of Grants, Reports and Manuscripts

The research coordinator will develop and write research reports, abstracts and academic manuscripts for publication in medical journals. The coordinator may also assist in grant submissions, including writing and coordination of relevant documents.

Job Type: Fixed term contract
Contract length: 12 months

Pay: From $26.20 per hour

Benefits:
Company events
Company pension
Dental care
Disability insurance
Employee assistance program
Extended health care
Flexible schedule
Life insurance
Paid time off

Education:
Master's Degree (preferred)

Work Location: Hybrid remote in Winnipeg, MB R2V 3M3