{"id":2634230,"url":"https://alion.io/job/axleinfo-clinical-protocol-coordinator","title":"Clinical Protocol Coordinator","company":{"id":4416199,"name":"Copyright Axle Informatics","domain":"axleinfo.com","url":"https://alion.io/company/axleinfo","size_band":null,"is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Greenhouse","truth_index":{"grade":"B","score":75,"open_postings":6,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-16T05:45:00Z"}},"role":"Administrative","role_family":"Administrative","seniority":"staff","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Bethesda, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":140000,"max":145000,"currency":"USD","period":"year","gross":null,"usd_annual":145000},"salary_estimate":null,"experience_years_min":9,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false},{"name":"Microsoft Office","optional":false},{"name":"SharePoint","optional":false}],"status":"live","first_seen_at":"2026-10-14T15:21:01Z","employer_posted_date":"2026-10-14","last_verified_at":"2026-10-16T08:26:34Z","board_verified":true,"closed_at":null,"days_open":1,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":1},"description":"(ID: 2026-3801)\nAxle is a bioscience and information technology company that offers advancements in translational research, biomedical informatics, and data science applications to research centers and healthcare organizations nationally and abroad. With experts in biomedical science, software engineering, and program management, we focus on developing and applying research tools and techniques to empower decision-making and accelerate research discoveries. We work with some of the top research organizations and facilities in the country including multiple institutes at the National Institutes of Health (NIH).\nAxle is seeking a Clinical Protocol Coordinator to join our vibrant team at the National Institutes of Health (NIH) supporting the National Institute of Neurological Disorders and Stroke (NINDS) located in Bethesda, MD.\nBenefits We Offer:\n100% Medical, Dental & Vision Coverage for Employees\nPaid Time Off and Paid Holidays\n401K match up to 5%\nEducational Benefits for Career Growth\nEmployee Referral Bonus\nFlexible Spending Accounts:Healthcare (FSA)\nParking Reimbursement Account (PRK)\nDependent Care Assistant Program (DCAP)\nTransportation Reimbursement Account (TRN)\n\nPosition Overview\nThe Clinical Protocol Coordinator will independently support the Division of Intramural Research, Clinical Trials Unit (CTU) at NINDS. The role provides regulatory and operational coordination throughout the clinical research protocol lifecycle, from development and initial submission through implementation and study closure. Responsibilities include preparing regulatory documentation, maintaining study records, tracking safety reporting and approvals, coordinating monitoring activities, and training research staff.\nAdditional Qualifications\nEducation\nMaster's degree.\nField of study: General Medical and Health Services.\nExperience and Qualifications\nMinimum of nine years of experience in clinical protocol coordination or a related field.\nFamiliarity with Institutional Review Board (IRB) requirements.\nPrevious clinical trial work.\nSoftware\nClinical Trial Management System (CTMS)\nSharePoint\nCRIS\nCiStar\nMicrosoft Office\nSkills\nTraining clinical trial site staff\nCoordinating project meetings\nDeliverables\nMaintain complete, current, and audit-ready regulatory files for each assigned protocol, including investigator qualifications, delegation logs, safety reports, approvals, and correspondence \nMeet with laboratory members to present updates \nPrepare, review, and submit protocol and regulatory packages, including initial submissions, amendments, continuing reviews, informed consent documents, protocol deviations, problem reports, annual reports, and closure documentation\nMaintain protocol trackers and status reports documenting submission dates, approval status, deadlines, monitoring activities, outstanding actions, safety reporting, and study closure\nReview and document safety and compliance findings, promptly communicate reportable issues to the Principal Investigator (PI) and Medically Responsible Investigator, and prepare safety reports within applicable regulatory timelines \nCoordinate monitoring visits, audits, inspections, and regulatory reviews; document findings and responses; and track corrective and preventive actions through resolution \nStatement of Work Details\nDevelop, assemble, review, and edit clinical research protocols, schemas, patient calendars, teaching aids, informed consent documents, and other ethics and regulatory documentation.\nDevelop and review standard operating procedures (SOPs) for clinical studies.\nPrepare and review study reports, status updates, amendments, annual reports, audit documentation, and other required administrative records.\nPrepare, review, and submit Investigational New Drug (IND) and Investigational Device Exemption (IDE) safety reports, clinical study reports, and regulatory correspondence, including initial submissions, information requests, amendments, and annual reports.\nMaintain complete and accurate regulatory binders, investigator qualifications, trial logs, safety reports, approvals, study applications, and correspondence.\nServe as a Protocol Navigator, providing day-to-day regulatory and operational support for assigned clinical research studies.\nManage, track, and report regulatory activities throughout the protocol lifecycle, from conception and development through study closure.\nMaintain study databases, conduct basic analyses, and track study requests, protocol submissions, approvals, deadlines, and outstanding actions.\nPrepare, review, and submit clinical data to monitoring agencies.\nCoordinate with IRB administrators to collect, review, and maintain IRB records and stay current on guidance for initial protocol and informed consent submissions and amendments.\nDevelop and submit protocol actions through the NIH Protocol Tracking and Management System.\nPrepare and submit regulatory packages to the IRB, Radiation Safety Committee, and other applicable oversight bodies.\nCoordinate communication with the IRB, NIH Clinical Center, and other NIH offices regarding protocol approvals, institutional policies, and regulatory requirements.\nTrack and review adverse events, toxicities, protocol deviations, participant safety concerns, and emerging trends; prepare required reports in accordance with IRB processes and policies.\nCommunicate safety concerns and significant protocol findings promptly to the PI and Medically Responsible Investigator.\nCoordinate monitoring visits, audits, inspections, and regulatory reviews, including quality assurance activities involving the Food and Drug Administration (FDA), NIH, pharmaceutical organizations, and other oversight entities.\nImplement and document revisions resulting from corrective and preventive action plans to support regulatory compliance and process improvement.\nEnsure research activities comply with Good Clinical Practice (GCP), NIH policies, FDA regulations, and applicable federal requirements governing human-subject research.\nSupport protocol coordination by matching and locating control subjects, completing registration phone calls, reviewing study questionnaires, and resolving patient queries.\nMaintain master subject lists, update enrollment status, assign study identification numbers, and obtain patient demographic information.\nCoordinate protocol activities with investigators, research coordinators, protocol navigators, CTU staff, safety personnel, monitoring entities, and collaborating NIH offices.\nParticipate in staff meetings, protocol development meetings, research coordinator forums, and multidisciplinary research meetings.\nProvide regulatory and clinical research support for the NINDS Intramural Research Program, including the Stroke Movement Disorders Program, Parkinson’s Disease Clinic, Behavioral Neurology Unit, and other assigned research programs.\nDevelop training plans and educate research staff on protocol development, trial conduct, regulatory changes, IRB and FDA submissions, radiation safety, ethics clearances, technology transfer, and protocol submission procedures.\nAdvise investigators on the documentation and approvals needed to initiate clinical studies based on the type, location, and complexity of the proposed research.\nMaintain current knowledge of clinical research regulations, guidance, and best practices through continuing education and required training.\nDisclaimer: The above description is meant to illustrate the general nature of work and level of effort being performed by individuals assigned to this position or job description. This is not restricted as a complete list of all skills, responsibilities, duties, and/or assignments required. Individuals may be required to perform duties outside of their position, job description or responsibilities as needed.\nThe diversity of Axle’s employees is a tremendous asset. We are firmly committed to providing equal opportunity in all aspects of employment and will not tolerate any illegal discrimination or harassment based on age, race, gender, religion, national origin, disability, marital status, covered veteran status, sexual orientation, status with respect to public assistance, and other characteristics protected under state, federal, or local law and to deter those who aid, abet, or induce discrimination or coerce others to discriminate.\nAccessibility: If you need an accommodation as part of the employment process please contact: \nThis role has a market-competitive salary with an anticipated base compensation range listed below. Actual salaries will vary depending on a candidate’s experience, qualifications, skills, and location.\nSalary Range\n$140,000—$145,000 USD","description_format":"text","description_chars":8704,"description_truncated":false,"requirements":{"experience_years_min":9,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"master","optional":false},"security_clearance":false,"languages":[]},"benefits":["401k plan"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Clinical Trial Services (CRO)"],"lifecycle":[{"event":"open","at":"2026-10-15T16:58:48Z"}],"visa":[],"liveness":{"score":86,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.86,"p_room":1,"age_days":1,"expected_fill_days":29,"reasons":["conf:2","win:early"],"computed_at":"2026-10-16T05:45:00Z"},"pay":{"stated_usd_annual":145000,"is_top_pay":true},"html_url":"https://alion.io/job/axleinfo-clinical-protocol-coordinator","json_url":"https://alion.io/job/axleinfo-clinical-protocol-coordinator.json","meta":{"generated_at":"2026-10-16T10:42:42Z","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":9239,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-17T00:00:00Z"}},"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":4416199},"rest":"https://alion.io/mcp/rest/get_company?id=4416199"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Faxleinfo-clinical-protocol-coordinator"},{"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%2Faxleinfo-clinical-protocol-coordinator"},{"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%2Faxleinfo-clinical-protocol-coordinator"},{"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/axleinfo-clinical-protocol-coordinator\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Faxleinfo-clinical-protocol-coordinator"}]}