Description:
Under the general supervision of the Director of Operations at the Centre for Innovative Medicine (CIM), the incumbent will act as a center coordinator on behalf of the RI management for various clinical research initiatives.
The Centre for Innovative Medicine is located in the Glen site hospital which is a unique center in Canada of 5000m2 dedicated exclusively to clinical research.
General Duties
- The incumbent will provide and help develop/maintain reports from the various systems being used for clinical research projects across the institution and Quebec.(i.e. – Nagano, myContracts, etc.). The incumbent will establish and maintain documentation for the tracking of timelines and maintenance of RI standards for excellence in submissions and project maintenance.
- The incumbent collaborates in the implementation and conduct of activities related to the Catalis FAST TRACK evaluation initiative to meet the goals identified for clinical trials in Québec.
- Maintenance and development of the Shared Investigator Platform (SIP) resource on behalf of the RI, the incumbent will collaborate with industry partners to ensure site information is up to date, investigators that are interested are registered and their profiles have been completed.
- Any other special projects that are related to clinical research development that is pertinent to future CIM/RI endeavors.
Specific Responsibilities
- Prepare reports and work to develop meaningful KPI/metrics, at the request of the CIM directors, including those related to Catalis Initiatives,
- Work closely with the Catalis team, on behalf of the RI-MUHC, and lead the implementation, oversight and conduct of the FAST TRACK evaluation service for clinical trials,
- Develop and maintain strong working relationships with MUHC, the Catalis Network, PI research teams and Research Institute personnel to ensure project goals are met,
- Ensure that all documents related to the sponsor’s Research Project are complete and compliant with the FAST TRACK Assessment Service documents and all MUHC/RI requirements are met prior to moving ahead with the project,
- Create and complete SIP registration for RI staff, departments and investigator profiles in a timely fashion,
- Attend or delegate meetings as needed,
- Perform all other duties related to this position.
A minimum of 3-5 years’ experience in clinical research management in a pharmaceutical company, in a contract research organization (CRO) and/or in a healthcare institution in Quebec.
Required Skills
- Proven experience in project oversight,
- Ability to plan, prioritize and multitask to meet deadline,
- Comfortable learning new tools and technologies,
- Proficiency in MS Office (Word, Excel),
- Critical thinking an asset,
- Solid written and verbal communication skills
- Autonomous, flexible sense of ethics and good judgment,
- Excellent interpersonal skills,
- Excellent organization, ability to multitasks and prioritize time-sensitive issues,
- Ability to work under minimal supervision
- Knowledge of international, federal and provincial laws and regulations governing clinical research (ICH-GCP) is an asset,
- Excellent French and English, spoken and written,
- Excellent communication and interpersonal skills,
- Ability to work independently or with teams with minimum supervision.