Clinical Research Manager

3 weeks ago


Ottawa, Canada University of Ottawa Heart Institute Full time

The University of Ottawa Heart Institute does not use artificial intelligence (AI) in its recruitment process. All hiring decisions are made through human review and evaluation.

Position overview

The University of Ottawa Heart Institute is seeking a highly motivated Clinical Research Manager to lead and support clinical research initiatives, including multi-centre trials and investigator-initiated studies, cardiac research operations oversight and team development.

Key responsibilities

- Oversee management of large-scale, multi-centre clinical trials and related projects.
- Coordinate all trial components from start-up to closure, including site initiation, progress monitoring, and study support.
- Generate study specific Standard Operating Procedures.
- Develop and maintain study-specific Standard Operating Procedures and Trial Master Files.
- Ensure adherence to policies and procedures, GCPs/ICH guidelines and regulatory requirements.
- Manage Serious Adverse Event (SAE) reporting and assist with status reports.
- Facilitate regular communication, investigator meetings, and newsletters.
- Coordinate research funds, budget negotiations, and site contracts.
- Site payment coordination with PI and finance teams.
- Identify and enroll eligible candidates for the research studies.
- Prepare and submit grant reports, ensuring compliance with funding agency requirements and timely communication of research progress and outcomes.
- Monitor the ongoing clinical status of patients and execution of all aspects of study visits.
- Supervise the clinical research staff related to project operations, working with the team to establish appropriate projectexpectations/timelines.
- Management of the administrative aspects of clinical research staff, working with human resources to set up employment contracts, manage leave and conduct annualappraisals.
- Liaise with multidisciplinary teams, including principal investigators, pharmacists, and administrative staff.
- Monitor data entry performance and documentation adequacy at participating centres.

Requirements

- Minimum 3 years of clinical research coordination experience.
- Proven experience managing multi-center clinical research trials.
- TCPS/GCP/Division 5 training (current).
- Excellent interpersonal, communication, and teamwork skills.
- Strong analytical, critical thinking, and computer skills.
- Ability to work under pressure, prioritize, and meet deadlines.
- Ability to write reports, create flowcharts, and prepare project plans/proposals.

Preferred qualifications

- CCRP/ACRP certification.
- Bilingual (English and French).
- Demonstrated clinical research experience.

Applications from Indigenous persons, members of racialized minorities, persons with disabilities, women, members of the LGBTQ + community, as well as from all qualified candidates with the skills and knowledge to productively engage with equitable, diverse and inclusive communities are strongly encouraged.

According to government policy, all qualified candidates are invited to apply; however, preference will be given to Canadians and permanent residents. When submitting your application, please indicate if you are legally entitled to work in Canada.

The University of Ottawa Heart Institute is committed to ensuring barrier-free selection processes and work environments. Accommodations will be provided in all parts of the hiring process relating to any specialty requirements. Please notify us of any accommodations that you require – any information you provide will be handled respectfully and in complete confidence.

The successful candidate will be required, prior to the start of employment, to complete mandatory organizational training available online, and provide the following: an official piece of photo identification and a satisfactory Criminal Record Check and proof of COVID-19 vaccine.

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