Research Project Manager I

4 weeks ago

Hamilton Ontario EH, Ontario, Canada Hamilton Health Sciences Full time

The Research Project Mnager I is to lead a team in the conduct of one or more research studies and accountable to the Principal Investigator (PI), (Associate) Program Manager/Program Director, Research Operations, and is responsible for the site and data management of clinical and patient based research studies, the supervision and training of study staff, and is the primary contact for internal support departments (statistics, contracts, finance, integrated technologies) and external stakeholders (sponsor, granting and funding agencies, investigational product packagers and distributers, study steering committees, and national leaders). Responsibilities include: Development and monitoring of study timelines and key deliverables in collaboration with internal and external stakeholders and project team members; With support from PI and/or operational leaders, request and evaluate various external vendors (e.g., CROs, drug depots, translation services, etc.) and facilitate contracts and budget negotiations with chosen vendors; Provide coordination and direction in the development of data management methodologies for multiple studies; including key data management methods such as; data collection, entry, verification, data validation, quality control, adjudication tracking and event reporting for large clinical data; Evaluate and review high level study reports for compliance, safety, and central monitoring for the duration of the trial and manage communication; Develop investigator training procedures and provide investigator site training to participating centres and external stakeholders; Assist investigational site staff with the accurate and timely completion of ethics and regulatory documents in accordance with the regulatory and GCP guidelines; Supervise and train project office staff; Development of research study budgets[ Support Principal Investigator(s) in preparation of proposals, grant budgeting and writing as it pertains to human resources, investigator site payments, Investigation product (if applicable), IT and system requirements, general study administration, licensing and operations for submission to local, national, and international granting agencies and organizations; Confirm that all relevant clinical and research methodology is applied and study procedures and documents meet ICH-GCP guidelines, national and international standards and guidelines (as applicable) for good clinical practice as this pertains to accountabilities in overall research study management, site management, data management, grants and financials and staff training.; and Verify all PHRI study operations and procedures are met according to SOP’s, provincial and national legislature, and practices or procedures set forth.


Qualifications

1. Undergraduate degree in Science or Health Science.
2. A clinical research certification (CCRP, ACRP or post-graduate certification in clinical research) is preferred.
3. Minimum of 3 years’ experience in multi-centre research studies and the management of large clinical research datasets.
4. 3 years supervisory experience and team coordination experience.
5. Excellent communication, problem solving skills and ability to work flexible hours.
6. Knowledge of ICH-GCP Guidelines and international research requirements.
7. Broad knowledge of research methodology, clinical trials and drug development processes.

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