Clinical Operations Coordinator

Description:

SetPoint Medical’s Clinical Operations Coordinator 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 Clinical Operations Coordinator works under the direction of Clinical Operations 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 site start-up activities, including collection and tracking of required documentation
• Assist Clinical Operations leadership with routine study coordination activities

Trial Master File (TMF) Support

• 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 preparation of TMF materials for audits and regulatory inspections

Investigational Device Logistics (Support Role)

• 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 (Administrative Support)

• 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

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)
• 1–3 years of experience in clinical research or clinical operations
• 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.