Lead Clinical Research Associate

Minimum of 4 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalent qualification level.

Must have 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-III.

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

Strong experience in GI (Chron's, Ulcerative Colitis, IBS) preferred.

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.

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.

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.