Cra Ii In-house (hybrid Role In Valencia, Ca)

SetPoint Medical’s In-House Clinical Research Associate II (CRA II) provides operational and administrative support for medical device clinical studies, including IDE and non-IDE investigations. This role supports the day‑to‑day execution of clinical studies by coordinating documentation, investigational device logistics, site communications, and operational tracking. Study Operations Support Provide administrative and operational support across the clinical study lifecycle (start‑up through close‑out). Track study milestones, timelines, and deliverables using study trackers and systems. Prepare materials for study team meetings and distribute meeting minutes as needed. Support study start‑up activities at sites by finalizing Informed Consent Form language, collecting and tracking essential study documents, and delivering regulatory and patient binders, training tools and other study supplies. Serve as the primary sponsor contact for clinical investigational sites on matters related to contracts, budgets, invoicing, vendors, and IRB submission. Assist Clinical Operations leadership with routine study coordination activities. Provide monitoring visit support as needed, e.g., assist with the visit preparation and support site qualification, site training, routine monitoring and close‑out visits, and monitoring visit reporting. Trial Master File (TMF) Setup and Maintenance Build and manage eTMF per clinical procedures and compliance with GCP guidelines, FDA regulations, and IRB requirements. Support maintenance of the sponsor Trial Master File (paper and/or electronic). File, index, and quality‑check essential study documents in accordance with the TMF plan. Track missing, incomplete, or overdue TMF documents and follow up with sites, CROs, and vendors. Assist with TMF reconciliation and inspection‑readiness activities. Support audit readiness by maintaining proper clinical trial documentation, conducting routine internal clinical file assessments, and participating in audits. Investigational Device Logistics Assist with ordering, shipment coordination, and tracking of investigational or commercial medical devices used in clinical studies. Maintain device shipment and accountability logs. Coordinate with depots, vendors, and clinical sites regarding device logistics. Support device reconciliation activities at study close‑out. Site & Vendor Coordination Serve as a point of contact for routine communications with clinical sites and vendors. Coordinate study‑related training sessions, meetings, and document exchange. Assist with vendor onboarding documentation and tracking of deliverables. Follow up on open action items and escalates issues as appropriate. Clinical Site Payments Track site payment milestones, invoices, and payment status. Maintain site payment trackers and supporting documentation. Coordinate invoice submission and review with Clinical Operations and Finance. Escalate payment discrepancies or delays to Clinical Operations leadership. Compliance & Quality Support Support compliance with applicable regulations, including 21 CFR 812, ISO 14155, and relevant ICH‑GCP principles. Ensure study documentation is maintained in accordance with internal SOPs. Assist with tracking protocol deviations and follow‑up actions. Maintain required training records and documentation. Support IRB submissions, amendments, and annual reports as applicable. May contribute to the development and improvement of company procedures, processes, templates, and trackers toward continuous quality improvement. Systems & Documentation Enter and maintain accurate study information in eTMF, CTMS, and other study systems. Maintain study trackers, logs, and operational documentation. Ensure timely and accurate documentation updates. Minimum Qualifications Bachelor’s degree in life sciences, health sciences, engineering, or a related field (or equivalent experience). 2–3 years of experience in medical device or pharmaceutical industry directly supporting investigational clinical studies. Working knowledge of CFRs, IDE, NDA, GCPs, and ICH Guidelines. Familiarity with clinical trial documentation and operational processes. Experience working with eTMF systems, CTMS, or similar tools preferred. Strong organizational skills and attention to detail. Ability to manage multiple tasks and priorities. Strong written and verbal communication skills. Success Competencies Detail‑oriented and highly organized. Proactive and reliable with the ability to follow established processes. Comfortable working cross‑functionally with internal teams and external partners. Able to thrive in a fast‑paced environment, managing multiple tasks independently and efficiently with minimal supervision. Exceptionally team‑focused, proactive, and motivated to drive quality and innovation in study execution. Consistently demonstrates ethical standards, promoting trust and respect across internal and external stakeholders. Physical Requirements Ability to sit at a desk and work on a computer for extended periods. Ability to lift up to 15 pounds occasionally. Work Location and Travel Hybrid position requiring regular in‑office presence at company headquarters in Valencia, CA, with approved remote workdays permitted in accordance with company policy. Minimal travel within the US (up to 20%) required. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification form upon hire. Candidates must have and maintain authorization to work within the United States as a condition of employment. We are proud to be an equal‑opportunity employer and we value diversity. SetPoint does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status, or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. #J-18808-Ljbffr