{"id":3598378,"url":"https://alion.io/job/psi-lead-clinical-research-associate-9","title":"Lead Clinical Research Associate","company":{"id":4862,"name":"PSI","domain":"psi-cro.com","url":"https://alion.io/company/psi-cro","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SmartRecruiters","truth_index":{"grade":"B","score":80,"open_postings":16,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":20,"computed_at":"2026-11-04T06:34:25Z"}},"role":"Biotech","role_family":"Biotech","seniority":"lead","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Sydney, Australia"],"countries":["AU"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":96000,"max_usd":227000,"period":"year","method":"global_role_cell_scaled_by_country","sample_n":137},"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"Microsoft Office","optional":false}],"status":"live","first_seen_at":"2026-11-02T05:39:25Z","employer_posted_date":"2026-11-02","last_verified_at":"2026-11-04T09:35:10Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"PSI is a leading Contract Research Organization (CRO) with over 30 years of experience in the pharmaceutical industry. Originating from Switzerland, PSI is a privately owned, full-service CRO with a global reach, supporting clinical trials across multiple countries and continents. Our reputation for being highly selective about the projects we undertake highlights our commitment to delivering high-quality, timely services across a broad spectrum of therapeutic indications.\nIn an industry where cost-cutting and layoffs are common, PSI stands out as a stable and secure workplace. Our dedication to stability is evident in our exceptionally high repeat and referral business rate and minimal staff turnover. More than 25% of our colleagues have been with us for over 10 years, contributing to our long-standing traditions and history.\nAt PSI, we foster an environment where a diverse range of colleagues feel welcomed and valued. Our inclusive culture is a cornerstone of our success, enabling us to attract and retain top talent globally.\nWe are not just about conducting clinical trials; we are about building a community where every team member has the opportunity to thrive and contribute to groundbreaking advancements in the pharmaceutical industry.\n As a Lead Clinical Research Associate, you will hold a leadership role within the study team, overseeing and guiding the clinical team while driving trial activities at a country or regional level. You will ensure high-quality execution, compliance, and timely delivery. You will act as a key point of coordination across cross-functional teams.\nThis role focuses on leadership, mentorship, oversight, and consistency in monitoring practices rather than direct site management, with minimal to no site assignments and a low-travel model, emphasizing remote oversight and overall study quality.\nResponsibilities:\nMonitors project timelines, patient enrollment, data cleaning, and ensuring compliance while implementing respective corrective and preventive measures.\nReviews monitoring visit reports for all visit types and ensures reporting compliance of the Monitors in the region.\nActs as the main communication line between Monitor, Site Management Associate, Regional Project Lead, and/ Project Manager.\nLeads project team calls on a country level as well as provides status updates and reports to Regional Lead/ Project Manager.\nProvides project-specific training and prepares training materials for the project team under supervision of a Project Manager and Regional Project Lead.\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.\nCollaborates with investigator/ site feasibility and identification process, as well as study startup.\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.\nCoordinates planning of supervised monitoring visits and conducts the visits. \nManages the project team in site contracting and payments.\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.\nDelivers trainings and presentations at Investigator Meetings.\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 Site Management Associates in the flow of documents and laboratory supplies between the site and the Central/ Regional Lab/ Central Reviewer.\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. \nExperience with all types of monitoring visits in Phase II and/or III.\nExperience in oncology, gastroenterology, infectious diseases, autoimmune diseases, or any rare disease indication is preferable.\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.\n 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.","description_format":"text","description_chars":5620,"description_truncated":false,"requirements":{"experience_years_min":4,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"Advanced (C1)","optional":false}]},"benefits":[],"hiring_locations":[{"name":"Australia","iso":"AU","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Clinical Trial Services (CRO)"],"lifecycle":[{"event":"open","at":"2026-11-02T06:16:27Z"}],"visa":[],"liveness":{"score":63,"band":"ok","label":"Likely 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