{"id":538354,"url":"https://alion.io/job/psi-lead-clinical-research-associate-2","title":"Lead Clinical Research Associate","company":{"id":4862,"name":"PSI","domain":"psi-cro.com","url":"https://alion.io/company/psi-cro","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SmartRecruiters","truth_index":{"grade":"B","score":80,"open_postings":11,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":20,"computed_at":"2026-10-21T05:46:15Z"}},"role":"Biotech","role_family":"Biotech","seniority":"lead","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Toronto, Canada"],"countries":["CA"],"hiring_countries":["CA"],"hiring_countries_total":1,"salary":{"min":124000,"max":153000,"currency":"CAD","period":"year","gross":null,"usd_annual":108953},"salary_estimate":null,"experience_years_min":4,"visa_sponsorship":true,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-08-14T19:11:55Z","employer_posted_date":"2026-08-14","last_verified_at":"2026-10-21T19:33:33Z","board_verified":true,"closed_at":null,"days_open":68,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":68},"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.\n Coordinates investigator/ site feasibility and identification process, as well as study startup.\nMonitors project timelines and patient enrollment, implements respective corrective and preventive measures.\nReviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region.\nManages Monitors in the query resolution process, including Central Monitoring observations.\nCoordinates safety information flow and protocol/process deviation reporting.\nPerforms clinical supplies management with vendors on a country and regional level.\nEnsures study-specific and corporate tracking systems are updated in a timely manner.\nActs as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager.\nCoordinates planning of supervised monitoring visits and conducts the visits. \nManages the project team in site contracting and payments.\nLeads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager.\nEnsures ongoing evaluation of data integrity and compliance at a country/regional level.\nConducts site audit preparation visits, may participate in site audits, and coordinates resolution of site audit findings on a country/regional level.\nOversees project team in CAPA development and implementation.\nCoordinates project team in process deviations review, management and reporting.\nConducts initial training and authorization monitoring visits for Monitors and acts as a mentor for newly promoted Lead CRAs.\nProvides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead.\nDelivers trainings and presentations at Investigator Meetings.\nPrepares, conducts and reports site selection, initiation, routine monitoring and closeout visits.\nEnsures that subject recruitment targets and project timelines are properly defined, communicated, recorded, and met at site level.\nEnsures accurate and timely information flow with trial sites on Adverse Events and protocol/process deviations.\nSupervises 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.\nEnsures proper handling, use, accountability, reconciliation, and return of all Investigational Product(s) and clinical study supplies on a country/region level.\nReviews essential study documents and supervises reconciliation of study Investigator Site File (ISF) / TMF at site level and country/region level.\nEnsures data integrity and compliance at a site level.\nSupervises Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer.\nConducts project-specific training of site Investigators.\nSupports preparation of draft regulatory and ethics committee submission packages.\n Relevant educational background, such as MD, MPharm, RN or College/University degree in Life Sciences or an equivalent combination of education, training and experience.\nMinimum of 4 years’ site monitoring experience with participation in global clinical projects as a Lead Monitor or equivalent qualification level. \nMust have prior experience monitoring or managing sites and CRAs with knowledge of US and Canadian regulatory guidelines and practices. \nExperience with all types of monitoring visits in Phases I-III. \nStrong experience in Oncology preferred.\nExperience in CAR-T Therapy or other types of Cell Therapy, Gene Therapy, Radiation Therapy or Radiopharmaceuticals, or Nuclear Medicine is preferred. \nStrong experience in GI (Chron's, Ulcerative Colitis, IBS) preferred. \nFull working proficiency in English.\nProficiency in MS Office applications.\nAbility to plan, multitask and work in a dynamic team environment.\nExcellent Communication, collaboration, and problem-solving skills.\nAbility to travel up to 65% (depending on project needs).\nValid driver’s license (if applicable).\n For this position, PSI is not hiring individuals who require work visa sponsorship for employment now or in the future.\nAdvance 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.","description_format":"text","description_chars":4591,"description_truncated":false,"requirements":{"experience_years_min":4,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":true},"security_clearance":false,"languages":[{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":[],"hiring_locations":[{"name":"Canada","iso":"CA","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Clinical Trial Services 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