{"id":841098,"url":"https://alion.io/job/orca-bio-clinical-research-associate","title":"Clinical Research Associate","company":{"id":4299,"name":"Orca Bio","domain":"orcabio.com","url":"https://alion.io/company/orca-bio","size_band":"501-1000","is_staffing_agency":false,"is_intermediary":false,"ats_vendor":"Lever","truth_index":{"grade":"B","score":81,"open_postings":16,"ghost_share":0,"stale_share":0.75,"repost_share":0,"time_to_fill_p50_days":58,"computed_at":"2026-09-23T05:45:00Z"}},"role":"Science & Research","role_family":"Science & Research","seniority":"senior","employment_type":"full_time","work_mode":"remote","remote_scope":"stated_countries","hiring_geo_confidence":"structured","locations":[],"countries":[],"hiring_countries":["US"],"hiring_countries_total":1,"salary":{"min":90000,"max":140000,"currency":"USD","period":"year","gross":null,"usd_annual":140000},"salary_estimate":null,"experience_years_min":5,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false}],"status":"live","first_seen_at":"2026-09-11T19:56:07Z","employer_posted_date":"2026-09-11","last_verified_at":"2026-09-23T19:31:17Z","board_verified":true,"closed_at":null,"days_open":12,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":12},"description":"Summary of Role: In this Clinical Research Associate role, you will be responsible for monitoring the progress of clinical studies, either at investigative sites or remotely, and ensure clinical trials are conducted, recorded, and reported in accordance with the protocol, standard operating procedures (SOPs), ICH-GCP, and all applicable regulatory requirements.\nWe are recruiting for two roles: one based on the West Coast and one based on the East Coast. Travel expected: ~1+ site visit per week, for sites that do not permit virtual monitoring.\nResponsibilities:\nMay serve as the primary monitor and main point of contact for assigned clinical sites\nConduct interim monitoring visits (IMVs) and ISF review\nReview electronic medical records (EMR)/patient data\nSource documentation verification (SDV) against case report form data, including informing the site staff of any entry errors, ensuring good documentation practices are being adhered to and communicating protocol deviations appropriately per SOPs, GCP and applicable regulatory requirements\nVerification and review of adverse events, serious adverse events, concomitant medications and corresponding illnesses to confirm accurate data reporting in accordance with the protocol\nProvide support to site staff including research coordinators and physicians\nAssist in the development of trial materials as needed (e.g., case report forms, monitoring guidelines, site tools and training guides)\nContribute to the development of Clinical Operations SOPs, best practices, work instructions, tools and templates\nAuthor and submit high-quality monitoring visit reports within required timelines\nEnsure completeness and accuracy of monitoring documentation in the eTMF\nQualifications:\nBA/BS or equivalent with a minimum of 2+ years of CRA experience (for CRA role) or 5+ years with lead monitor responsibilities (Senior CRA)\nTherapeutic experience in oncology/hematology and cell and gene therapy preferred\nPrior CRA experience working directly for sponsor, ideally a start-up/or small company, with primary site ownership and independent monitoring responsibility\nStrong working knowledge of FDA and ICH/GCP regulations and guidelines and thorough knowledge of clinical monitoring procedures\nExperience with Trial Master File management according to the DIA reference model\nExperience operating within various site EMR/EHR systems\nExperience using eTMF, EDC (IBM Zelta experience ideal), CTMS, and other vendors systems/portals, as well as working on trials without a CTMS in place\nPersonal Qualities:\nHighly detail oriented with special attention to quality and quality control \nAbility to multitask and handle multiple responsibilities simultaneously; able to prioritize \nWell organized and able to work under tight deadlines\nDemonstrated strong work ethic, curiosity to learn and contribute in a fast-paced collaborative environment \nStrong interpersonal skills, including verbal and written communication, are essential\nAbility to work in a collegial and collaborative manner; independently and as part of a team\nAbility to work in a fast-paced and informal startup environment\nHighly tolerant and respectful of all members of our team \nStrong problem-solving skills with desire to improve upon established processes\nSense of humor","description_format":"text","description_chars":3289,"description_truncated":false,"requirements":{"experience_years_min":5,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":null,"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[{"name":"United States","iso":"US","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Clinical Research","Biotechnology","Health Care","Cell & Gene Therapy"],"lifecycle":[{"event":"open","at":"2026-09-12T21:51:03Z"}],"liveness":{"score":60,"band":"ok","label":"Likely open","p_open":1,"p_active":0.602,"p_room":1,"age_days":11,"expected_fill_days":58,"reasons":["conf:0","stale_co","win:early"],"computed_at":"2026-09-23T05:45:00Z"},"pay":{"stated_usd_annual":140000,"is_top_pay":false},"html_url":"https://alion.io/job/orca-bio-clinical-research-associate","json_url":"https://alion.io/job/orca-bio-clinical-research-associate.json","meta":{"generated_at":"2026-09-23T20:07:34Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers"}}