Description:
The Clinical Research Unit (CRU) of the Montreal Neurological Institute-Hospital (the Neuro) conducts over 120 clinical trials and clinical research projects in adult neuroscience. Research Administrators oversee clinical trial activity at the CRU, for a subset of clinical trials in one of the specialized disease indication group and are central to fulfilling the institution’s quaternary care mandate.
Primary Responsibilities:
- Administer clinical trials and clinical research projects at the Clinical Research Unit at the Neuro
- Provide information to various stakeholders about the projects (sponsors, CRO, PI, etc.).
- Ensure continuous support to Investigators/Physicians in the delivery of up-to-date research activities and information, confirming priorities and timeframes of clinical trial participants. Read and understand clinical trial protocols. In conjunction with medical staff, organize the administrative and logistical aspects of study procedures (calendar, book vendors and clinicians, schedule monitors and provide study binders, etc.), and collect, transcribe and communicate relevant data.
- Collect appropriate information from participants and relay it to the best person (PI, nurses, vendors, etc.) as well as proceed to data entry to various platforms. Ensure that the activities are performed in accordance with each applicable regulatory requirements and University and sponsors policies and procedures.
- Complete and submit project and ethics applications and renewal as necessary in the Nagano platform
- Communicate information to medical staff, patients and pharmaceutical companies on new information pertaining to the research projects, regulatory information, etc.
- Instruct patients, researchers and nurses to follow protocol according to GCP guidelines.
- Liaison between researcher, patient and pharmaceutical company. Attends all internal and external meetings as requested by the medical director and/or the pharmaceutical company for each clinical trial the coordinator is responsible for.
- Functions as a record-keeper in terms of clinical trial and clinical research project information and is accountable for the follow-up of business.
- Perform other administrative duties as required.