Research Project Coordinator III

hhsc; Hamilton; On-site; CAD 65,000 - 85,000; Full time

Job summary

Hamilton Health Sciences, in partnership with PHRI, seeks a Research Project Coordinator III to lead clinical and patient-based studies and serve as the main liaison for internal and external stakeholders.

You will develop study management plans, train staff, monitor sites, review data quality, and manage timelines and deliverables in collaboration with the team. Strong ICH-GCP knowledge and ED C experience are essential.

Qualifications

• Bachelor’s degree in Health Sciences or related field and 3+ years of coordinating multi-centre research studies.
• Experience with large clinical research datasets and knowledge of ICH-GCP guidelines and international research requirements.
• Highly developed leadership, communication and problem solving skills.
• Strong computer skills and extensive experience with Microsoft Office and electronic data capture systems (iDataFax or TrialMaster).
• Broad knowledge of research methodology, clinical trials and drug development processes.

Responsibilities

• Lead a team in conducting one or more clinical and patient-based research studies and act as primary contact for internal and external stakeholders.
• Coordinate study management plans (site management, data management, safety management).
• Support staff training; develop study-specific documentation; perform site monitoring and visits to ensure protocol adherence.
• Evaluate and review high-level study reports for data accuracy and reporting; prepare and present reports; organize data transfers with external stakeholders.
• Develop and monitor timelines and key deliverables in collaboration with stakeholders and project team members; manage IP distribution and quality control.

Skills

Leadership

Data management

Communication

Problem solving

ICH-GCP knowledge

MS Office

EDC systems

Education

Bachelor’s degree in Health Sciences or related

Tools

iDataFax

TrialMaster

Job description

The Population Health Research Institute (PHRI), a joint institute of Hamilton Health Sciences and McMaster University, with over 300 employees working directly with 60 researchers. PHRI conducts clinical research internationally in 105 countries and is a world leader in large, global health and population and health outcomes research. Our capacity to conduct multiple international studies concurrently, with tens of thousands of participants in each, is a capability very few organizations in the world can match.

The Research Project Coordinator III leads a team in the conduct of one or more clinical and patient-based research studies in addition to taking up the role as the primary contact for internal support and external stakeholders. Responsiblities include: Provide coordination in the development of study management plans (e.g., site management plan, data management plan, safety management plan); Support training to staff: Preparation, design and/or support development of study specific documentation; Perform site monitoring and site visits to confirm adherence to study protocol, procedures, ICH- GCP guidelines, local and national regulations and guidelines; Evaluate and review high level study reports to confirm accuracy in data reporting for data monitoring and study committees; Prepare and present reports; organize and facilitate data transfers with external stakeholders; Development and monitoring of study timelines and key deliverables in collaboration with internal and external stakeholders; Management and administration of IP distribution, IP quality control and requirements per product monograph; Mentor and support study staff by suggesting plans or training programs professional growth and development to aid team members in reaching their career goals; Support Principal Investigator(s) in preparation of proposals, grant budgeting and writing as it pertains to human resources, investigator site payments, Investigation product, IT and system requirements; Collaborate and provide guidance to supporting departments for the maintenance of study systems and development of study specific contracts; and Development and monitoring of study timelines and key deliverables in collaboration with internal and external stakeholders and project team members.

Monday-Friday; 37.5 hours weekly

This position is temporary until November 2027.

1. 1. Bachelor’s degree in Health Sciences or related areas of study as well as 3+ years of work experience in the coordination of multi‑centre research studies.
2. 2. Experience with management of large clinical research datasets and applicable knowledge of ICH‑GCP Guidelines and international research requirements.
3. 3. Highly developed leadership, communication and problem solving skills.
4. 4. Highly efficient computer skills and extensive experience with the Microsoft Office suite, and electronic data capture systems such as iDataFax or TrialMaster.
5. 5. Broad knowledge of research methodology, clinical trials and drug development processes.

Hamilton Health Sciences fosters a culture of patient and staff safety, whereby all employees are guided by our Mission, Vision, Values, and Values Based Code of Conduct. Hamilton Health Sciences is a teaching hospital and all staff and physicians are expected to support students and other learners.

To be considered for this opportunity applicants must apply during the posting period. All internal and external applicants may ONLY apply via the Careers website. This job posting is for an existing vacancy.

Hamilton Health Sciences is an equal opportunity employer and we will accommodate any needs under the Canadian Charter of Rights and Freedom, Accessibility for Ontarians with Disabilities Act and the Ontario Human Rights Code. Hiring processes will be modified to remove barriers to accommodate those with disabilities, if requested. Should any applicant require accommodation through the application processes, please contact Human Resources at 905-521-2100, Ext. 46947 for assistance. If the applicant requires a specific accommodation because of a disability during an interview, the applicant will need to advise the hiring manager when scheduling the interview and the appropriate accommodations can be made.

This competition is open to all qualified applicants, however, qualified internal applicants will be considered first. Past performance will be considered as part of the selection process. If you are a previous employee of Hamilton Health Sciences, please note: the circumstances around an employee's exit will be considered prior to an offer of employment. Proficiency in both Official Languages, French and English, is considered an asset.

If this position is temporary, selection for this position will be as per the outlined Collective Agreements:

Article 30 (k), CUPE Collective Agreement

Article 10.7 (d), ONA Collective Agreement

Article 13.01 (b) (ii), OPSEU 273 Collective Agreement

Article 14.04, OPSEU 209 Collective Agreement

Article 2.07 and Article 13, PIPSC RT Collective Agreement