CRA II In-house

SetPoint Medical • Valencia, CA

23h • Hybrid

About The Position

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. The CRAII works under the direction of Clinical Affairs leadership to ensure studies are conducted efficiently and in compliance with applicable regulations, internal SOPs, and study requirements.

Requirements

• Bachelor’s degree in life sciences, health sciences, engineering, or a related field (or equivalent experience)
• 2-3 year 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

Nice To Haves

• Experience working with eTMF systems, CTMS, or similar tools preferred

Responsibilities

• 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 start­up 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 necessary study supplies
• Can be the primary sponsor contact for clinical investigational sites on the matters related to contracts, budgets, invoicing, vendors, and IRB submission
• Assist Clinical Operations leadership with routine study coordination activities
• Provides monitoring visit support as needed, e.g., helps with the visit preparation and supports site qualification, site training, routine monitoring and close out visits, as well as monitoring visit reporting, if needed
• Build and manage eTMF per clinical procedures and in 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
• 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
• 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 escalate issues as appropriate
• 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
• 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 towards continuous quality improvement
• 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

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 11-50 employees