{"id":2103129,"url":"https://alion.io/job/polypore-sr-clinical-research-associate","title":"Sr. Clinical Research Associate","company":{"id":2254853,"name":"Polypore","domain":"polypore.com","url":"https://alion.io/company/polypore","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workday","truth_index":{"grade":"B","score":79,"open_postings":6,"ghost_share":0,"stale_share":0.833,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-13T05:45:00Z"}},"role":"Science & Research","role_family":"Science & Research","seniority":"senior","employment_type":"full_time","work_mode":"hybrid","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Cary, United States"],"countries":["US"],"hiring_countries":[],"hiring_countries_total":0,"salary":{"min":100000,"max":115000,"currency":"USD","period":"year","gross":null,"usd_annual":115000},"salary_estimate":null,"experience_years_min":3,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false},{"name":"Microsoft Office","optional":false},{"name":"Outlook","optional":false}],"status":"live","first_seen_at":"2026-10-08T19:21:43Z","employer_posted_date":"2026-10-08","last_verified_at":"2026-10-13T03:13:52Z","board_verified":true,"closed_at":null,"days_open":4,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":4},"description":"The Asahi Kasei Group operates with a commitment of creating for tomorrow. Our business sectors,Materials, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.\nAsahi Kasei Therapeutics is the global specialty pharmaceutical business of Asahi Kasei. We are a commercial-stage company committed to positively impacting health by expanding therapeutic options that improve the lives of patients around the world. Drawing upon our strong heritage of scientific innovation, we aim to help reshape care in transplantation, nephrology, immunology, infectious diseases and other underserved conditions.\nJob Description:\nThe Clinical Research Associate (CRA) is a primarily in-house, sponsor-side Clinical Operations role responsible for supporting clinical trial execution through centralized site management, monitoring oversight, data review, document quality control, and study tracking. This position is expected to perform many non-travel responsibilities, including routine review of monitoring visit reports, Trial Master File (TMF) and investigator file maintenance, site communication follow-up, issue escalation, operational tracker maintenance, and support of inspection-readiness activities. The CRA partners closely with CRO monitors, clinical project managers, vendors, and cross-functional team members to help ensure clinical trials are conducted in accordance with the protocol, SOPs, Good Clinical Practice (GCP), ICH guidelines, and applicable regulatory requirements. Limited domestic or international travel may be required for investigator meetings, site engagement, or oversight activities, but the core responsibilities of the role are performed remotely or in-house.\nThe base compensation range for this role is $100-115K. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.\nSummary of Key Responsibilities\nAssist with all phases of clinical trial activities (start-up, maintenance, close out).\nReview site monitoring visit reports to identify potential site non-compliance and monitoring deficiencies and ensures sponsor oversight.\nSupport the team in essential document review.\nPerform centralized review of clinical data listings, EDC queries, protocol deviations, site metrics, and study dashboards to support data quality, enrollment tracking, and timely issue resolution.\nAssist the Clinical Project Manager by monitoring the performance of the CRO’s monitors.\nAssist with the oversight of site performance to ensure compliance with protocol, quality measures, and adherence to scope of work within timelines. Maintain tracking spreadsheets/databases, as required.\nAssist with filing and management of the Trial Master File (TMF). Review the investigator folders of the TMF on a regular basis to ensure all required documents have been submitted and are filed in accordance with the study TMF Plan. \nProvide proactive site interactions to encourage enrollment and study timeline compliance.\nDemonstrate independent site management capabilities (compliance, deliverables, relationship, and troubleshooting).\nParticipate in trial meetings, such as kick-off, investigator, and monitor meetings, providing support as needed. May need to travel to site monitoring visits as necessary.\nSupport tracking of operational study timelines and monitors operational performance metrics through the life of the study; supports issue resolution.\nAssist in the review of informed consents, case report forms, study operations manuals, monitoring tools, and other study-related materials.\nTrack site level progress to ensure timely data collection, source document verification, and query resolution.\nEnsure timely safety reporting at assigned investigative sites.\nParticipate in data listings review.\nRequired Qualifications and Skills\nEducation/Training:\nLife science degree, advanced scientific, or clinical degree or equivalent degree or experience.\nPrevious Experience:\nAt least 3 years’ monitoring experience.\nAbilities/Skills:\nStrong understanding of ICH GCP guidelines and region-specific regulatory guidelines (e.g., FDA, EMEA, PMDA, etc.).\nAbility to work with minimal supervision.\nSuperior communication skills, both written and oral.\nExceptional attention to detail and problem-solving skills.\nFlexibility to adapt to changing priorities and manage activities to meet the needs of the department while maintaining a focus on quality.\nAbility to take initiative, prioritize, and execute tasks and special projects with minimal direction or supervision, maintaining a high level of confidentiality, integrity, and discretion at all times.\nAbility to work effectively across different levels and functions.\nAbility to travel domestically and internationally, as required.\nWillingness to “roll up his/her sleeves” to get the job done.\nProficient in MS Office Suite (Excel, Word, Outlook, PowerPoint).\nTravel Requirements: Approximately 25%\n#LI-AS1 #Hybrid\nAs an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and 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