{"id":3275577,"url":"https://alion.io/job/icon-lead-cra-principal-cra","title":"Lead CRA/ Principal CRA","company":{"id":5677,"name":"ICON","domain":"iconplc.com","url":"https://alion.io/company/icon","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":81,"open_postings":49,"ghost_share":0,"stale_share":0.98,"repost_share":0,"time_to_fill_p50_days":12,"computed_at":"2026-10-29T05:49:05Z"}},"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":["Blue Bell, United States"],"countries":["US"],"hiring_countries":["US"],"hiring_countries_total":1,"salary":null,"salary_estimate":{"min_usd":106000,"max_usd":200000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":11},"experience_years_min":4,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"CAPA","optional":false},{"name":"GCP","optional":false},{"name":"Good Clinical Practice","optional":false},{"name":"Veeva","optional":false}],"status":"live","first_seen_at":"2026-09-25T00:00:00Z","employer_posted_date":"2026-09-25","last_verified_at":"2026-10-29T05:57:02Z","board_verified":true,"closed_at":null,"days_open":34,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":34},"description":"Lead Clinical Research Associate - Oncology - USAt ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.\nAs the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.\nPosition:\nWe are seeking a highly experienced, collaborative, and detail-oriented Lead CRA capable of helping our client optimize its clinical Site Engagement and Monitoring function to support delivery of world class clinical drug development.\nThe successful candidate will work closely with the sponsor’s Site Engagement and Monitoring Excellence (SEME) team, global Functional Service Provider (FSP) Clinical Research Associates (CRAs) and internal study teams across therapeutic areas to oversee clinical site engagement and monitoring activities.\nAbout You:\nYou have significant monitoring experience and a passion for training and mentoring other CRAs. You are adept at developing and maintaining relationships with clinical trial sites and demonstrate the ability to execute monitoring with a strong knowledge of Good Clinical Practice and clinical trial regulations to ensure subject safety, data integrity and inspection readiness. You are a strong collaborator across clinical functional areas with a demonstrated ability to creatively and independently resolve complex issues that impact sites. You are able to successfully develop and maintain positive site relationships in parallel with ensuring optimal trial conduct and quality with our client's clinical trial sites within your territory.\nWhat You’ll Do:\nDevelop and maintain strong clinical trial site relationships to support a positive site/patient experience and accelerate the progress of study milestones such as enrollment and major study milestones.\nPromote awareness of sponsor's clinical pipeline and programs to trial sites, investigators, and networks.\nConduct Monitoring Oversight Visits on behalf of sponsor to assess FSP CRA monitoring quality and site inspection readiness.\nExecute remote or on-site qualification of sites for sponsor trials as needed, and promptly facilitate site selection.\nSchedule and conduct Site Initiation, Interim Monitoring and Close-Out visits as needed to co-monitor, train and/or onboard FSP CRAs across oncology trials. On-site visits are preferred at sponsor.\nReview and approve FSP CRA Monitoring Visit Reports.\nRegularly review site and monitoring Key Risk Indicator (KRI) metrics to detect issues and ensure prompt resolution across regional territory. Contribute to developing the Study and Site Risk Assessment Tool.\nTrain and re-train FSP CRAs and sites on GCP, the protocol, vendor processes and study-specific documents.\nPerform consistent site management and act as an escalation point for FSP CRAs to resolve monitoring quality issues; develop/ensure implementation of site Corrective and Preventive Action (CAPA) Plans and escalate as needed.\nEnsure sites are inspection-ready and support the sponsor during site inspections.\nEffectively utilize the CTMS and Trial Master File (TMF) to ensure that SEME and site documents are promptly filed and site data is accurate; audit the site TMFs as needed.\nIndependently draft, review or contribute to the development of a Site Monitoring Plan as needed.\nContribute to monitoring process improvement initiatives by reviewing and/or developing functional area Standard Operating Procedures (SOPs), Work Instructions (WIs), job aids, and tools.\nContribute to improving site selection, monitoring, and monitoring oversight trip report templates in Veeva CTMS and the EDC by identifying gaps, suggesting updates, testing and implementing change controls as needed.\nEstablish and foster effective relationships with internal and external stakeholders, such as investigators, site staff, sponsor study team members and FSP CRAs.\nQualifications/Requirements\nMinimum education: Completion of a bachelor’s degree (scientific or clinical field) is required. An advanced degree is preferred.\n8+ years monitoring Oncology (solid tumor) trials (with a minimum of 4 years monitoring phase I and/or Phase III Oncology) is required.\nPrevious experience independently conducting on-site and remote monitoring visits (site qualification, initiation, monitoring, and close-out) is required.\nExperience utilizing Veeva CTMS and TMF is required.\nExperience supporting site and/or sponsor inspections is preferred.\nExperience auditing sites and TMF are preferred.\nEmployment with ICON is contingent upon having the legal right to work in the country where the role is based.\nRewards & Benefits\nICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.\nBenefits may include:\nCompetitive base salary and performance related incentives\nHealth and wellbeing programmes including medical, dental, and vision coverage where applicable\nRetirement and pension plans\nLife assurance and disability coverage\nEmployee assistance programmes and wellbeing resources\nLearning and development opportunities through structured training and career pathways\nBenefits may vary depending on role and location.\nVisit our careers site to read more about the benefits ICON offers.\nInclusion and Accessibility\nICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.\nIf you require reasonable accommodations during the recruitment process, please let us know or submit a request here.\nAre you a current ICON Employee? Please click here to apply","description_format":"text","description_chars":5732,"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":[]},"benefits":["Retirement plans"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Clinical Trial Services (CRO)"],"lifecycle":[{"event":"open","at":"2026-10-26T14:35:10Z"}],"visa":[],"liveness":{"score":10,"band":"cold","label":"Long shot","p_open":1,"p_active":0.291,"p_room":0.35,"age_days":34,"expected_fill_days":12,"reasons":["conf:4","stale_co","velocity","win:tail","comp:brand"],"computed_at":"2026-10-29T05:49:05Z"},"pay":null,"html_url":"https://alion.io/job/icon-lead-cra-principal-cra","json_url":"https://alion.io/job/icon-lead-cra-principal-cra.json","meta":{"generated_at":"2026-10-29T09:00:19Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":13602,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-30T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":5677},"rest":"https://alion.io/mcp/rest/get_company?id=5677"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Ficon-lead-cra-principal-cra"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Ficon-lead-cra-principal-cra"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Ficon-lead-cra-principal-cra"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/icon-lead-cra-principal-cra\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Ficon-lead-cra-principal-cra"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3275577}},{"tool":"search_jobs","arguments":{"company":"iconplc.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3275577},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. Docs: https://alion.io/developers"}}