Research Coordinator II

Hamilton Health Sciences

  • Hamilton, ON
  • Permanent
  • Temps-partiel
  • À l'instant
The Research Coordinator’s purpose is to lead a team in the conduct of one or more research studies. The Research Coordinator is accountable to the Principal Investigator (PI) and or Program Manager (PM) and is responsible for all aspects of research projects highlighted below.
  • Act as the primary contact for internal support departments and external stakeholders.
  • Development and monitoring of study timelines.
  • Provide coordination and direction in the development of data management methodologies for multiple studies; including key data management methods.
  • Provide coordination and direction in the development of site management practices for multiple studies; including collection and maintenance of essential site documentation per ICH-GCP guidelines, management and preparation of regulatory and health authority documentation, research ethics board documents and study contact information.
  • Engage in ongoing communication and coordinate regular meetings with key study specific stakeholders.
  • Prepare presentations for external and/or internal meetings.
  • Adhere to all related compliance, safety and monitoring.
  • Prepare all ethics and regulatory documents in accordance with the institution and regulatory and GCP guidelines.
  • Coordinate communication with all internal and external collaborators.
  • Coordinate training of study teams/centers on all aspects of clinical study procedures.
  • Coordinate /perform site monitoring and site visits to confirm adherence to study protocol, procedures, ICH-GCP guidelines, local and national regulations and guidelines.
  • Help develop research study budgets, in collaboration with PI’s and other collaborators.
  • Help administer multiple study and sub-study accounts.
  • Negotiate budgets with vendors, sites and other collaborators.
  • Support Principal Investigator(s) in preparation of proposals, grant budgeting and writing.
  • Manage day to day study finance and study budgeting.
QualificationsBachelor's degree in a relevant field of study.Minimum 3 years previous experience in multi-center research studies/clinical trials or other research projects.Experience with the management of large clinical research studies and or databases.Working knowledge of ICH-GCP Guidelines and international research requirements.Highly efficient computer skills, extensive experience with the Microsoft office suite.Supervisory experience and team coordination.Assets:A clinical research certification (CCRP, ACRP or post-graduate certification in clinical research) is preferred.Other desirable assets:Excellent communication, problem solving skills and teamwork skillsBroad knowledge of research methodology, clinical trials and drug development processes. * Experience with REB and CTO application and amendment documents preferred
  • Data collection and management experience with REDCap including revisions of projects and data collection
  • Experience coordinating study start-up activities, protocol review, site initiation visit, participant recruitment and visits, data collection, regulatory submissions, study close out and ensuring compliance with applicable regulatory requirements and documentation (eg. ICH-GCP E6 R2 and R3, TCPS, WHO Best Practices for Clinical Trials).
  • Experience performing all aspects of study visits, including obtaining informed consent, conducting visit procedures, collecting data, completing case report forms (paper and electronic), maintaining source documents, and scheduling follow-ups.
  • Enter and maintain accurate study data in electronic data capture systems, ensuring data quality and completeness.
  • Experience collecting, processing, and shipping laboratory specimens per protocol requirements.
  • Experience tracking investigational products, lab samples, and study supplies as needed.
Experience with presentation for internal and external study meetings.

Hamilton Health Sciences