06 Sep
|
Socket.dev
|
Canada
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 skilled 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.
- 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.
- Experience with management of large clinical research datasets and applicable knowledge of ICH-GCP Guidelines and international research requirements.
- Highly developed leadership, communication and problem solving skills.
- Highly efficient computer skills and extensive experience with the Microsoft Office suite, and electronic data capture systems such as iDataFax or TrialMaster.
- Broad knowledge of research methodology, clinical trials and drug development processes.
📌 Research Project Coordinator III (Canada)
🏢 Socket.dev
📍 Canada