{"id":1756872,"url":"https://alion.io/job/evolution-research-group-regulatory-affairs-associate","title":"Regulatory Affairs Associate","company":{"id":3876300,"name":"Evolution Research Group","domain":"ergclinical.com","url":"https://alion.io/company/evolution-research-group","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"ADP","truth_index":{"grade":"B","score":75,"open_postings":11,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-08T05:49:30Z"}},"role":"Public Policy","role_family":"Public Policy","seniority":null,"employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Staten Island, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":20,"max":28,"currency":"USD","period":"hour","gross":null,"usd_annual":56000},"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false},{"name":"HIPAA","optional":false},{"name":"Microsoft Office","optional":true}],"status":"live","first_seen_at":"2026-08-13T14:42:00Z","employer_posted_date":"2026-08-13","last_verified_at":"2026-10-08T17:52:13Z","board_verified":true,"closed_at":null,"days_open":56,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":56},"description":"About Company:\nEvolution Research Group (ERG) is dedicated to delivering high-quality Phase I-IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S. and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.\nWhy join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge.\nJob Description:\nThe Regulatory Affairs Assistant supports efforts to ensure regulatory submission targets are met. Completes all duties under the direction of the Regulatory Manager or Site Director. In executing these position responsibilities, the Regulatory Coordinator is guided by Good Clinical Practices (GCP), International Conference on Harmonization (ICH) guidelines, Health Insurance Portability and Accountability Act (HIPAA) and company standard operating procedures and policies.\nResponsibilities:\nAdministrative:\nGeneral understanding of GCP/ICH guidelines\nAssist with collecting and preparing regulatory documents for submission to sponsor and IRB.\nAssist with maintaining current regulatory-related documents to include CVs, licenses, and required training documents.\nAssist with set-up of electronic Investigator Site File for all awarded studies.\nCollect signatures on regulatory documents as required.\nAssist with maintaining current study logs such as Screening and Enrollment Logs, Training Logs\nAssist with filing study-related correspondence (sponsor, IRB, etc.) in the Investigator Site File. \nAssist with resolution to regulatory items identified during monitoring visits.\nMaintain current training with applicable SOPs/WIs, GCP, etc.\nAssist with archiving of study documents following study closure.\nAdditionally, this role may encompass responsibilities beyond those outlined above, as required by the evolving needs of the organization. This job description is intended as a foundation and may be subject to expansion or modification to best suit ERG’s objectives.\nSkills and Qualifications:\nEducation and experienceHigh School Diploma or its equivalent; Two-year degree preferred.\nClinical Research experience preferred but not required.\n\n RequirementsWorking knowledge of medical terminology and the clinical research process \nAttention to detail.\nOrganizational Skills\nStrong computer skills, including knowledge of all components of Microsoft Office are required.","description_format":"text","description_chars":2832,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"high_school","optional":false},"security_clearance":false,"languages":[]},"benefits":["Health insurance"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Health Care","Clinical Trial Sites & Recruitment"],"lifecycle":[{"event":"open","at":"2026-10-03T11:06:29Z"}],"visa":[],"liveness":{"score":10,"band":"cold","label":"Long shot","p_open":1,"p_active":0.276,"p_room":0.35,"age_days":55,"expected_fill_days":21,"reasons":["conf:1","stale_co","win:tail"],"computed_at":"2026-10-08T05:49:30Z"},"pay":{"stated_usd_annual":56000,"is_top_pay":false},"html_url":"https://alion.io/job/evolution-research-group-regulatory-affairs-associate","json_url":"https://alion.io/job/evolution-research-group-regulatory-affairs-associate.json","meta":{"generated_at":"2026-10-09T00:43:11Z","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","counted_by":"address","units_charged":1,"used_today":1031,"day_limit":5000,"remaining_today":3969,"minute_limit":60,"resets_at":"2026-10-10T00:00:00Z"}},"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":3876300},"rest":"https://alion.io/mcp/rest/get_company?id=3876300"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fevolution-research-group-regulatory-affairs-associate"},{"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%2Fevolution-research-group-regulatory-affairs-associate"},{"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%2Fevolution-research-group-regulatory-affairs-associate"},{"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/evolution-research-group-regulatory-affairs-associate\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fevolution-research-group-regulatory-affairs-associate"}]}