Clinical Research Coordinator

Research Project(s)

Do you want to evolve within one of the largest francophone research centers in North America and participate in the most stimulating research projects? The Research Center of the CHU de Québec-Université Laval is an organization that offers a stimulating work environment where new ideas, knowledge sharing, and self-improvement are valued.

The selected person will join the intensive care neurology and trauma research group, currently composed of 25 employees (team manager, research coordinators, research nurses, research professionals, biostatisticians, administrative assistant). This group develops, directs, and participates in prospective studies at the intensive care unit (mainly intervention clinical trials) funded by public funding agencies following a peer-review process (Canadian Institutes of Health Research (CIHR)).

Job Description, Tasks, and Responsibilities

The person holding the position plans, organizes, coordinates, and supervises activities related to the implementation of clinical research projects for which recruitment is planned at the facility. They act as a resource person for the sponsor to ensure the effective deployment of studies, compliance with regulatory requirements, and achievement of operational objectives. They also oversee the conduct of studies and the research personnel under their responsibility.

Operational Coordination of Studies

• Plan and coordinate the start-up, implementation, and closure of clinical trials for which recruitment is planned at the facility;
• Evaluate the operational feasibility of new projects and identify the need for human, material, and technological resources as required;
• Develop implementation plans for studies at the facility and monitor schedules;
• Ensure coordination with the sponsor and their coordination team;
• Identify operational issues that may affect the conduct of studies and implement appropriate corrective measures;
• Monitor the overall progress of projects.
• Preparation, Deployment, and Closure of Studies
• Participate in the development of project procedures, work guides, and tracking tools;
• Coordinate the preparation of essential documents for conducting studies specific to our team;
• Supervise the maintenance of the team's research documentation;
• Perform project submissions to institutional systems and electronic platforms, including Nagano;
• Follow up with the research ethics committee;
• Assist in tracking service agreements, contracts, and other commitments related to studies via the Nagano system and the contracts office;
• Ensure the implementation of recruitment, data collection, participant follow-up, and document management processes;
• Plan and organize initiation visits, study training, and start-up activities with the sponsor;
• Coordinate the closure activities of clinical trials, including data verification, resolution of pending queries, and preparation of required documentation for project closure;
• Ensure regulatory closure of studies, including submission of reports when necessary, archiving of essential documents, and compliance with the sponsor, research ethics committee, and regulatory bodies.
• Regulatory and Document Management
• Monitor approvals, renewals, modifications, and reports required throughout the duration of studies;
• Ensure the maintenance of essential documentation in accordance with Good Clinical Practices (GCP), regulatory requirements, and institutional procedures;
• Supervise the management of regulatory files;
• Ensure the maintenance of task delegation records, mandatory training, and personnel compliance documents.
• Quality and Compliance Management
• Ensure the application of GCP, standardized operational procedures, and applicable regulatory requirements;
• Participate in the development, implementation, and continuous improvement of quality processes;
• Supervise the preparation of monitoring, audit, and inspection activities, if applicable;
• Monitor observations, deviations, non-compliances, and corrective and preventive action plans.
• Personnel Management and Supervision
• Supervise, mentor, and support the research personnel under their responsibility;
• Participate in the onboarding, training, and integration of new employees;
• Allocate projects and responsibilities based on skills and workload;
• Foster collaboration, communication, and knowledge sharing within the team.
• Strategic Development and Continuous Improvement
• Participate in the resolution of complex operational issues affecting projects;
• Identify opportunities for process improvement and propose innovative solutions;
• Contribute to the development and implementation of tools, procedures, and practices aimed at operational excellence.
• Participation in Research Activities

According to operational needs and priorities, the person holding the position may contribute directly to certain clinical research activities such as:

• Participate in participant recruitment and follow-up;
• Perform or supervise data collection, validation, and entry;
• Contribute to data query resolution and database quality control;
• Support the research team during peak periods or in replacement situations;
• Participate in monitoring visits and study follow-up activities when required.

Required Qualifications

• Hold a Bachelor's degree;
• At least one year of experience as a research coordinator;
• Experience in clinical research;
• Training in Good Clinical Practices (GCP) and Health Canada Division 5;
• Strong interpersonal skills and demonstrated ability to build harmonious working relationships with various professionals (doctors, nurses, research professionals, etc.);
• Good communication skills.
• Specific Skills
• Strong organizational, time management, and project management skills;
• Versatility, multitasking;
• Proactivity, initiative, and ability to work autonomously with minimal supervision;
• Attention to detail, precision.

Working Conditions

• Work location: Research Center of the CHU de Québec-Université Laval, Hôpital de l'Enfant-Jésus site;
• Start date: as soon as possible;
• Duration: 12 months (with a strong possibility of renewal)
• Salary: according to the existing salary structure
• Vacation: 20 days
• Holidays: 13 days
• Sick leave: 7 days
• Depending on eligibility, access to collective insurance plans with employer contribution;
• Retirement regime (RREGOP)
• CHU privileges: discounts at various partners (restaurants, shops, fitness, leisure, hotels, health centers, spa, etc.), if applicable.

We thank all applicants, but we will only communicate with those selected for an interview.

Valuing equity, diversity, and excellence, the Research Center of the CHU de Québec applies an equal opportunity employment program and is committed to offering its entire staff a work and living environment infused with an inclusive culture. For the Research Center of the CHU de Québec, diversity is a source of richness, and we encourage qualified individuals of all origins, genders, sexual orientations, gender identities or expressions, and people with disabilities to apply.

Salary: $31.52 to $58.64 per hour

Benefits

• Disability Insurance
• Supplementary Health Insurance
• Life Insurance
• Retirement Regime
• Training:
• Bachelor's degree (Required)
• Job Location: On-site