CRA II In-house (Hybrid Role in Valencia, CA)
SetPoint Medical, Santa Clarita, CA, United States
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.
Job Responsibilities
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
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 elevate 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 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
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: Exempt
Location: Hybrid (based in Valencia, CA)
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
Job Responsibilities
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
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 elevate 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 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
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: Exempt
Location: Hybrid (based in Valencia, CA)
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