{"id":3372818,"url":"https://alion.io/job/caris-life-sciences-clinical-study-documentation-specialist","title":"Clinical Study Documentation Specialist","company":{"id":1953796,"name":"Caris Life Sciences","domain":"carislifesciences.com","url":"https://alion.io/company/carislifesciences","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":79,"open_postings":7,"ghost_share":0,"stale_share":0.857,"repost_share":0,"time_to_fill_p50_days":39,"computed_at":"2026-10-29T05:49:05Z"}},"role":"Product","role_family":"Product","seniority":"junior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Phoenix, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":73000,"max_usd":145000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":397},"experience_years_min":2,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false},{"name":"HIPAA","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Outlook","optional":false},{"name":"Good Clinical Practice","optional":true}],"status":"live","first_seen_at":"2026-10-27T00:00:00Z","employer_posted_date":"2026-10-27","last_verified_at":"2026-10-29T06:23:32Z","board_verified":true,"closed_at":null,"days_open":2,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":2},"description":"At Caris, we understand that cancer is an ugly word-a word no one wants to hear, but one that connects us all. That’s why we’re not just transforming cancer care-we’re changing lives.\nWe introduced precision medicine to the world and built an industry around the idea that every patient deserves answers as unique as their DNA. Backed by cutting-edge molecular science and AI, we ask ourselves every day:“What would I do if this patient were my mom?”That question drives everything we do.\nBut our mission doesn’t stop with cancer. We're pushing the frontiers of medicine and leading a revolution in healthcare-driven by innovation, compassion, and purpose.\nJoin us in our mission to improve the human condition across multiple diseases. If you're passionate about meaningful work and want to be part of something bigger than yourself, Caris is where your impact begins.\nPosition Summary\nThe Clinical Study Documentation Specialist provides clinical study support for Caris-sponsored studies and collaborative pharmaceutical research initiatives. The activities in this role will be conducted in alignment with internal standard operating procedures (SOPs), regulatory requirements, and industry best practices. Responsibilities include maintaining study documentation, coordinating Institutional Review Board (IRB) submissions, engaging with research sites through regular meetings, and regular assessments of clinical study documents to confirm they are current, complete, and compliant.\nJob Responsibilities\nSupport initiation and maintenance of clinical trials by preparing and submitting study documents including protocols, informed consent forms, investigator brochures, and amendments to IRBs and other oversight entities.\n\nMaintain accurate and up-to-date clinical study files and documentation, including licenses, staff certifications, training records, and equipment logs, ensuring all required elements are readily available for inspection or audit.\n\nCoordinate and conduct regular reviews of study binders and systems to ensure documents are non-expired, complete, and aligned with protocol requirements.\n\nServe as a liaison between internal teams, research sites, IRBs, and sponsors to facilitate clear communication, resolve issues, and ensure timely regulatory submissions and approvals.\n\nTrack study progress in applicable databases and platforms, updating milestones and document statuses in clinical trial management systems (CTMS), IRB portals, spreadsheets, and sponsor systems as required.\n\nAssist with site onboarding and study activation, providing study guidance and support throughout the trial lifecycle.\n\nParticipate in internal and external meetings, including site calls and sponsor touchpoints, to provide updates on study status and clinical study documentation timelines.\n\nSupport compliance with federal, state, and local regulations, as well as GCP, HIPAA, FDA, OHRP, and other applicable guidelines.\n\nAssist with the development and delivery of GCP training for internal stakeholders and research staff.\n\nMaintain awareness of changes in clinical regulatory processes and assist in the development of new processes or SOPs as needed.\n\n Required Qualifications\nAssociates degree\n\n2 years experience with preparing and submitting documents to Institutional Review Boards (IRBs).\n\nStrong understanding of clinical research documentation, clinical regulatory processes, and protocol development.\n\nProficient in Microsoft Office Suite (Word, Excel, Outlook) and capable of navigating internet-based systems for regulatory and trial management.\n\nStrong organizational skills and attention to detail in documentation and communication.\n\nAbility to manage multiple studies and competing priorities with minimal supervision.\n\nSuccessful completion of pre-employment requirements including criminal background check, drug screening, and reference check.\n\n Preferred Qualifications\nWorking knowledge of ICH-GCP, FDA, DHHS, and OHRP regulations and guidelines.\n\nBachelor's degree in life sciences, healthcare, or a related field.\n\nAt least two years of experience in a clinical research or regulatory environment.\n\nExperience working with electronic clinical trial management systems (CTMS).\n\nCertifications such as CCRC, CCRP, or RAC are a plus.\n\n Physical Demands\nAbility to sit or stand for prolonged periods (more than 1 hour at a time).\n\nAbility to lift up to 30 lbs as needed.\n\n Training\nCompletion of Good Clinical Practices (GCP), Human Subject Protection, and HIPAA training.\n\nAll job specific, safety, and compliance training are assigned based on the job functions associated with this employee.\n\nOther\nAvailability to respond to after-hours issues in rare cases where urgent regulatory support is required.\n\nConditions of Employment: Individual must successfully complete pre-employment process, which includes criminal background check, drug screening, credit check( applicable for certain positions) and reference verification.\nThis job description reflects management’s assignment of essential functions. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.\nCaris Life Sciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, gender, gender identity, sexual orientation, age, status as a protected veteran, among other things, or status as a qualified individual with disability.","description_format":"text","description_chars":5512,"description_truncated":false,"requirements":{"experience_years_min":2,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"associate","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Genomics & Genetic Testing","Precision Medicine"],"lifecycle":[{"event":"open","at":"2026-10-28T01:42:27Z"}],"visa":[],"liveness":{"score":90,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.903,"p_room":1,"age_days":2,"expected_fill_days":39,"reasons":["conf:4","velocity","win:early","comp:junior,brand"],"computed_at":"2026-10-29T05:49:05Z"},"pay":null,"html_url":"https://alion.io/job/caris-life-sciences-clinical-study-documentation-specialist","json_url":"https://alion.io/job/caris-life-sciences-clinical-study-documentation-specialist.json","meta":{"generated_at":"2026-10-29T11:13:51Z","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":16981,"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":1953796},"rest":"https://alion.io/mcp/rest/get_company?id=1953796"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fcaris-life-sciences-clinical-study-documentation-specialist"},{"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%2Fcaris-life-sciences-clinical-study-documentation-specialist"},{"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%2Fcaris-life-sciences-clinical-study-documentation-specialist"},{"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/caris-life-sciences-clinical-study-documentation-specialist\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fcaris-life-sciences-clinical-study-documentation-specialist"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":3372818}},{"tool":"search_jobs","arguments":{"company":"carislifesciences.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":3372818},"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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