Research Project Coordinator III

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. Duties 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.

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. Experience with management of large clinical research datasets and applicable knowledge of ICH-GCP Guidelines and international research requirements.
3. Highly developed leadership, communication and problem solving skills.
4. Highly efficient computer skills and extensive experience with the Microsoft Office suite, and electronic data capture systems such as iDataFax or TrialMaster.
5. Broad knowledge of research methodology, clinical trials and drug development processes