{"id":3472511,"url":"https://alion.io/job/lifelancer-fsp-sr-cra-i","title":"FSP Sr. CRA I","company":{"id":3853997,"name":"Lifelancer","domain":"lifelancer.com","url":"https://alion.io/company/lifelancer","size_band":null,"is_staffing_agency":true,"employer_type":"agency","is_intermediary":true,"listed_via":null,"ats_vendor":null,"truth_index":null},"role":"Biotech","role_family":"Biotech","seniority":"senior","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"inferred_payroll_markers","remote_working_hours":null,"hiring_geo_confidence":"inferred","locations":[],"countries":[],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":90000,"max":113000,"currency":"USD","period":"year","gross":null,"usd_annual":113000},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"Good Clinical Practice","optional":false}],"status":"live","first_seen_at":"2026-10-29T15:22:28Z","employer_posted_date":null,"last_verified_at":"2026-10-29T15:22:28Z","board_verified":false,"closed_at":null,"days_open":7,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":7},"description":"Job Title: FSP Sr. CRA I\nJob Location: Remote, California, USA\nJob Location Type: Remote\nJob Contract Type: Full-time\nJob Seniority Level: Work Schedule\nStandard (Mon-Fri)Environmental Conditions\nOfficeJob DescriptionJoin Us as Senior Clinical Research Associate I – Make an Impact at the Forefront of Innovation. We have successfully supported the top 50 pharmaceutical companies and more than 750 biotechs, spanning 2,700 clinical trials across 100+ countries in the last 5 years.\nDESCRIPTIONAs a Senior Clinical Research Associate I in our FSP model, you will be dedicated to one specific client, acting as a representative of the client while exercising strong communication and collaboration skills. You will perform and coordinate all aspects of the clinical monitoring and site management process. You will conduct remote or on-site visits to assess protocol and regulatory compliance and manage required documentation. You will act as a site processes specialist, ensuring that the trial is conducted in accordance with the approved protocol, ICH-GCP guidelines, applicable regulations and SOPs to guarantee subjects rights, well-being and data reliability. You will ensure audit readiness and develop collaborative relationships with investigational sites.\nWhat You'll Do:\nMonitors investigator sites with a risk-based monitoring approach.\n\nApplies root cause analysis (RCA), critical thinking and problem-solving skills to identify site processes failure and corrective/preventive actions to bring the site into compliance and decrease risks.\n\nEnsures data accuracy through SDR, SDV and CRF review as applicable through on-site and remote monitoring activities.\n\nAssess investigational product through physical inventory and records review.\n\nDocuments observations in reports and letters in a timely manner using approved business writing standards.\n\nEscalates observed deficiencies and issues to clinical management expeditiously and follow all issues through to resolution.\n\nMaintains regular contact between monitoring visits with investigative sites to confirm that the protocol is being followed, that previously identified issues are being resolved and that the data is being recorded in a timely manner.\n\nConducts monitoring tasks in accordance with the approved monitoring plan.\n\nParticipates in the investigator payment process.\n\nEnsures a shared responsibility with other project team members on issues/findings resolution.\n\nInvestigates and follows-up on findings as applicable.\n\nProvides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required.\n\nEnsures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS).\n\nPerforms QC check of reports generated from CTMS system where required.\n\nParticipates in investigator meetings as necessary.\n\nIdentifies potential investigators in collaboration with the client company to ensure the acceptability of qualified investigative sites.\n\nInitiates clinical trial sites according to the relevant procedures to ensure compliance with the protocol and regulatory and ICH GCP obligations, making recommendations where warranted.\n\nEnsures trial close out and retrieval of trial materials.\n\nEnsures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations.\n\nConducts on-site file reviews as per project specifications.\n\nContributes to the project team by assisting in preparation of project publications/tools, and sharing ideas/suggestions with team members.\n\nPerforms additional study tasks as assigned by CTM (e.g. trip report review, newsletter creation, lead CRA team calls etc).\n\nFacilitates effective communication between investigative sites, the client company and the project team through written, oral and/or electronic contacts.\n\nResponds to company, client and applicable regulatory requirements/audits/inspections.\n\nMaintains & completes administrative tasks such as expense reports and timesheets in a timely manner.\n\nContributes to other project work and initiatives for process improvement, as required.\n\nREQUIREMENTSEducation and Experience Requirements:\nBachelor's degree in a life sciences related field or a Registered Nursing certification or equivalent and relevant formal academic / vocational qualification.\n\nPrevious experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years).\n\nOncology experience preferred.\n\nKnowledge, Skills and Abilities:\nA seasoned, experienced professional, with a full understanding of area of specialization; resolves a wide range of issues in creative ways.\n\nStrong critical thinking and problem-solving skills.\n\nExcellent clinical trials monitoring skills; remote and on-site.\n\nDemonstrated understanding of ICH-GCP guidelines, applicable regulations and SOPs.\n\nWorks on problems of diverse scope where analysis of data requires evaluation of identifiable factors.\n\nDemonstrates good judgement in selecting methods and techniques for obtaining solutions.\n\nStrong communication and collaboration skills with ability to interact effectively with investigative sites, clients, and internal teams.\n\nAbility to act as a representative of the client while maintaining professional relationships.\n\nAdvanced written and oral communication skills.\n\nStrong organizational skills and attention to detail.\n\nDemonstrated use of computer systems including CTMS and other trial management platforms.\n\nAbility to travel >75% as required for site monitoring activities.\n\nWhy Join Us?When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.\nApply today to help us deliver tomorrow's breakthroughs.\nCompensation and Benefits\nThe salary range estimated for this position based in California is $90,000.00–$113,000.00.This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:\n\nA choice of national medical and dental plans, and a national vision plan, including health incentive programs\n\nEmployee assistance and family support programs, including commuter benefits and tuition reimbursement\n\nAt least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy\n\nRetirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan\n\nEmployees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount\n\nFor more information on our benefits, please visit: \n\nThis job is curated by Lifelancer.Lifelancer is a talent-hiring platform in Life Sciences, Pharma and IT. The platform connects talent with opportunities in pharma, biotech, health sciences, healthtech and IT domains.\nPlease apply via Lifelancer platform to get connected to the application page and to find similar roles.\nOriginally posted on Himalayas","description_format":"text","description_chars":7408,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":["Life insurance","Parental leave","Retirement plans"],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care","Internet Services","Healthcare Staffing"],"lifecycle":[{"event":"open","at":"2026-10-29T17:28:15Z"}],"visa":[],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":6,"expected_fill_days":29,"reasons":["seen:6","velocity","win:early","comp:brand"],"computed_at":"2026-11-05T05:54:30Z"},"pay":{"stated_usd_annual":113000,"is_top_pay":false},"html_url":"https://alion.io/job/lifelancer-fsp-sr-cra-i","json_url":"https://alion.io/job/lifelancer-fsp-sr-cra-i.json","meta":{"generated_at":"2026-11-05T16:11:49Z","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":21288,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-11-06T00:00:00Z"}},"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":3853997},"rest":"https://alion.io/mcp/rest/get_company?id=3853997"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Flifelancer-fsp-sr-cra-i"},{"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%2Flifelancer-fsp-sr-cra-i"},{"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%2Flifelancer-fsp-sr-cra-i"},{"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/lifelancer-fsp-sr-cra-i\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Flifelancer-fsp-sr-cra-i"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3472511}},{"tool":"search_jobs","arguments":{"company":"lifelancer.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3472511},"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. 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