Lead Clinical Research Associate

PSI CRO is hiring a Lead Clinical Research Associate in Canada. This is a senior monitoring role that combines site-level work with oversight of monitors and site management associates across a country or region. It suits someone with at least four years of site monitoring experience who has already led monitoring on global trials and wants to take on team leadership, training, and audit responsibilities.

What you will do

• Coordinate investigator and site feasibility, identification, and study startup.
• Monitor project timelines and patient enrollment, and put corrective and preventive measures in place when needed.
• Review monitoring visit reports for all visit types and check that monitors in the region are reporting as required.
• Manage monitors through the query resolution process, including Central Monitoring observations.
• Coordinate safety information flow and protocol and process deviation reporting.
• Handle clinical supplies management with vendors at country and regional level.
• Keep study-specific and corporate tracking systems up to date.
• Act as the main communication line between monitors, site management associates, the regional project lead, and the project manager.
• Plan supervised monitoring visits and conduct them.
• Manage the project team on site contracting and payments.
• Lead project team calls at country level and report status updates to the regional lead or project manager.
• Evaluate data integrity and compliance on an ongoing basis at country and regional level.
• Conduct site audit preparation visits, may take part in site audits, and coordinate resolution of audit findings.
• Oversee the project team in CAPA development and implementation.
• Coordinate the project team in reviewing, managing, and reporting process deviations.
• Run initial training and authorization monitoring visits for monitors, and mentor newly promoted Lead CRAs.
• Provide project-specific training and prepare training materials for the project team under the supervision of a project manager and regional project lead.
• Deliver trainings and presentations at investigator meetings.
• Prepare, conduct, and report site selection, initiation, routine monitoring, and closeout visits.
• Make sure subject recruitment targets and project timelines are defined, communicated, recorded, and met at site level.
• Keep information flowing accurately and on time with trial sites on adverse events and protocol or process deviations.
• Supervise source data verification, follow up on data queries at site level, and review and manage study risks at site level.
• Ensure proper handling, use, accountability, reconciliation, and return of investigational products and clinical study supplies.
• Review essential study documents and supervise reconciliation of the investigator site file and TMF at site and country or regional level.
• Supervise site management associates on the flow of documents and laboratory supplies between the site and the central or regional lab or central reviewer.
• Conduct project-specific training of site investigators.
• Support preparation of draft regulatory and ethics committee submission packages.

What they are looking for

• A relevant educational background, such as MD, MPharm, RN, or a college or university degree in life sciences, or an equivalent combination of education, training, and experience.
• At least 4 years of site monitoring experience, including participation in global clinical projects as a lead monitor or at an equivalent qualification level.
• Prior experience monitoring or managing sites and CRAs, with knowledge of US and Canadian regulatory guidelines and practices.
• Experience with all types of monitoring visits in Phases I to III.
• Strong experience in oncology is preferred.
• Experience in CAR-T therapy or other cell therapy, gene therapy, radiation therapy or radiopharmaceuticals, or nuclear medicine is preferred.
• Strong experience in GI (Crohn's, ulcerative colitis, IBS) is 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.
• A valid driver's license, if applicable.

Pay and location

The role is based in Canada and pays CAD 124,000 to 153,000 per year.

About PSI CRO

PSI is a contract research organization with more than 30 years in the industry. The company describes itself as offering a balance between stability and innovation to clients and employees, and focuses on delivering quality and on-time services across a variety of therapeutic indications.