Contract Clinical Research Associate

Contract Clinical Research AssociateContractCompany DescriptionWe are the company that cares – for our staff, for our clients, for our partners and for the quality of the work we do. A dynamic, global company founded in 1995, we bring together close to 3,000 driven, dedicated and passionate individuals. We work on the frontline of medical science, changing lives, and bringing new medicines to those who need them.Job DescriptionAs a Clinical Research Associate at PSI you will enjoy a variety of monitoring tasks and work on clinical studies in different therapeutic indications, maintaining the highest quality standards in the industry.You will:Act as the main line of communication between the project team, sponsor, and the siteBuild and maintain a good relationship with the site staff involved in the study conductPrepare, conduct, and report site selection, initiation, routine monitoring and close-out visitsEnsure that subject recruitment targets are timely defined, communicated, recorded and met, and project timelines are followed at site levelEnsure accurate and timely information flow with trial sites on Adverse Events and protocol/process deviationsPerform source data verification and follows up on data queries at site level; review and manage study risks on a site levelEnsure proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on sitesReview essential study documents and reconcile study Investigator Site File (ISF) / TMF at site levelEnsures quality (data integrity and compliance) at site levelConduct site audit preparation visits and resolve site audit findingsParticipate in study site audits and client onsite visits, as requiredEnsure the flow of documents and study supplies between the project team, site and the Central/ Regional Laboratory/ Central Reviewer/ WarehouseConduct project-specific training of site investigatorsSupport preparation of Investigator newslettersAssist Site Management Associates in maintaining study-specific and corporate tracking systems at site levelSupport preparation of draft regulatory and ethics committee submission packagesSupport collection of IP-RED packages at site/country levelFacilitate review and reconciliation of the study TMF on country and site levelsQualificationsCollege/University degree in Life Sciences or an equivalent combination of education, training & experienceLocated in Canada (West Coast)5+ years of independent on-site monitoring experienceExperience in all types of monitoring visits, in phases I-IIIExperience independently monitoring Oncology clinical trials requiredExperience independently monitoring Gastroenterology (IBD) clinical trials requiredProficiency in MS Office applicationsAbility to plan, multitask and work in a dynamic team environmentCommunication, collaboration, and problem-solving skillsAbility to travel up to 75%Valid driver’s licenseBy clicking the link above or any third-party link within this posting, you are leaving this site and going to a third-party website where the third-party website's terms and privacy policy applyI'm interestedI'm interestedPrivacy Notice