• Compensation: CAD 124000 - CAD 153000 - yearly

Company Description

PSI is a leading Contract Research Organization with more 30 years in the industry, offering a perfect balance between stability and innovation to both clients and employees. We focus on delivering quality and on-time services across a variety of therapeutic indications.

Job Description

• Coordinates investigator/ site feasibility and identification process, as well as study startup.


• Monitors project timelines and patient enrollment, implements respective corrective and preventive measures.


• Reviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region.


• Manages Monitors in the query resolution process, including Central Monitoring observations.


• Coordinates safety information flow and protocol/process deviation reporting.


• Performs clinical supplies management with vendors on a country and regional level.


• Ensures study-specific and corporate tracking systems are updated in a timely manner.


• Acts as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager.


• Coordinates planning of supervised monitoring visits and conducts the visits.


• Manages the project team in site contracting and payments.


• Leads project team calls on a country level as well as providesstatus updates and reports to Regional Lead/ Project Manager.


• Ensures ongoing evaluation of data integrity and compliance at a country/regional level.


• Conducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level.






• Oversees project team in CAPA development and implementation.


• Coordinates project team in process deviations review, management and reporting.


• Conducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs.


• Provides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead.


• Delivers trainings and presentations at Investigator Meetings.


• Prepares, conducts and reports site selection, initiation, routine monitoring and closeout visits.


• Ensures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level.


• Ensures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations.


• Supervises source data verification and follows up on data queries at site level in the country/region; reviews and manages study risks on a site level.


• Ensures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level.


• Reviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level.


• Ensures data integrity and compliance at a site level.






• Supervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer.


• Conducts project-specific training of site Investigators.


• Supports preparation of draft regulatory and ethics committee submission packages.

Qualifications

• Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience.


• Minimum of 4years’ site monitoring experience with participationin global clinical projects as a Lead Monitor or equivalentqualificationlevel.


• Must have prior experience monitoring or managing sites and CRAswith knowledge of US and Canadian regulatory guidelines and practices.


• Experience with all types of monitoring visits in Phases I-III.


• Strong experience in Oncology preferred.


• Experience in CAR-T Therapy or other types of Cell Therapy, Gene Therapy, Radiation Therapy or Radiopharmaceuticals, or Nuclear Medicine is preferred.


• Robust experience in GI (Chrons, Ulcerative Colitis, IBS) preferred.


• Full working proficiency in English.


• Proficiency in MS Office applications.


• Ability to plan, multitask and work in a dynamic team environment.


• Excellent Communication, collaboration, and problem-solving skills.


• Ability to travel up to 65% (depending on project needs).


• Valid driver’s license (if applicable).

Additional Information

Advance your career in clinical research, coordinating a variety of tasks and learning new things while growing with a rapid growing company that puts its people first.