CRA II In-house at SetPoint Medical

Valencia, California, United States -

Full Time

Start Date

Immediate

Expiry Date

14 Jul, 26

Salary

0.0

Posted On

15 Apr, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Clinical Research, Medical Device, Clinical Study Operations, Trial Master File (TMF), GCP Guidelines, FDA Regulations, Regulatory Compliance, CTMS, Site Coordination, Investigational Device Logistics, Data Management, Protocol Deviation Tracking, Informed Consent, Vendor Management, Clinical Site Payments, Audit Readiness

Industry

Medical Equipment Manufacturing

Description

Description 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 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 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 Trial Master File (TMF) Setup and Maintenance •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 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 escalate 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 towards 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 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 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. Location This is a 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. Company Description SetPoint Medical is a commercial-stage medical technology company dedicated to improving care for people living with chronic autoimmune diseases. Department: Clinical Reports To: Director, Clinical Affairs FLSA Status: Non-Exempt Location: In-house 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.

Responsibilities

The CRA II provides operational and administrative support for medical device clinical studies, including managing study documentation and site communications. They are responsible for maintaining the Trial Master File, coordinating investigational device logistics, and ensuring compliance with regulatory standards.