Clinical Operations Coordinator Jobs in USA with Visa Sponsorship
Clinical Operations Coordinators manage clinical trial logistics, site coordination, and regulatory compliance, roles that consistently qualify as specialty occupations under H-1B and E-3 visas. Employers across academic medical centers, CROs, and biopharma companies sponsor these positions, particularly for candidates with life sciences degrees and trial coordination experience.
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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.
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.
How to Get Visa Sponsorship as a Clinical Operations Coordinator
Target CROs and biopharma companies first
Contract research organizations like ICON, Syneos, and Parexel sponsor clinical ops roles at high volume. They hire internationally trained coordinators regularly and have established immigration infrastructure, making sponsorship conversations significantly more straightforward than with smaller employers.
Align your degree to the role explicitly
H-1B specialty occupation requires a directly related bachelor's degree. A degree in clinical research, public health, nursing, or life sciences strengthens your petition. Employers need to document the connection between your field of study and the coordinator role itself.
Highlight GCP certification and ICH guidelines knowledge
Good Clinical Practice certification signals to both employers and USCIS that your qualifications meet industry standards. It differentiates you in the applicant pool and supports the specialty occupation argument by demonstrating specialized, regulated knowledge beyond a generalist background.
Ask about sponsorship timing before the offer stage
Clinical ops roles often have urgent start timelines tied to trial phases. Raise visa needs early so hiring managers can loop in HR and legal counsel before an offer is extended, avoiding delays that could cause you to miss a trial startup window.
Understand cap-exempt employer options
Hospitals, academic medical centers, and nonprofit research institutions are often H-1B cap-exempt, meaning they can file outside the annual lottery. If you miss the H-1B cap, these employers can hire you year-round without waiting for the next registration period.
Document your trial coordination experience in detail
USCIS scrutinizes clinical operations roles during adjudication. Offer letters and support letters should specify protocol management, IRB submissions, site monitoring, and data integrity responsibilities, not just a generic job title, to clearly establish specialty occupation eligibility.
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Get Access To All JobsFrequently Asked Questions
Does a Clinical Operations Coordinator role qualify as a specialty occupation for H-1B purposes?
Yes, in most cases, provided the employer requires a bachelor's degree or higher in a specific field such as clinical research, life sciences, nursing, or public health. USCIS looks at whether the degree requirement is a genuine industry standard for the role. Coordinators at academic medical centers and established CROs tend to have stronger petitions because their job descriptions are more clearly degree-dependent and well-documented in industry hiring norms.
What visa types are most commonly used to sponsor Clinical Operations Coordinators?
H-1B is the most common pathway, covering coordinators employed by private biopharma companies, CROs, and hospitals. Australian citizens can use the E-3 visa, which has no lottery and significantly shorter wait times. TN visas are available to Canadian and Mexican nationals if the role maps to an eligible TN occupation category. Cap-exempt employers, including many academic medical centers, can file H-1B petitions year-round outside the annual lottery.
How competitive is H-1B sponsorship for this role, and what affects approval odds?
Approval rates for clinical operations roles are generally solid when the specialty occupation case is well-documented. The main risk is an RFE arguing the position doesn't require a specific degree. Coordinators with clearly specialized responsibilities, such as IRB management, protocol deviation tracking, or IND submissions, have stronger cases than those in generalist administrative support roles. Petitions filed by large employers with established immigration counsel tend to have fewer issues.
Do I need a specific degree, or will any bachelor's degree qualify?
A degree directly related to clinical research, biology, public health, nursing, or a related life science is strongly preferred. USCIS may challenge a petition if your degree is in an unrelated field, such as business or communications, even if you have years of relevant experience. If your degree doesn't match, some employers will use the three-for-one experience substitution rule, where three years of qualifying work experience replaces one year of college education.
Where can I find Clinical Operations Coordinator jobs that offer visa sponsorship?
Migrate Mate is built specifically for international job seekers and filters roles by sponsorship availability, so you're not wasting time on postings that won't support your visa. Many clinical ops roles with sponsorship are at CROs, biopharma companies, and academic hospital systems. Browsing by employer type on Migrate Mate can help you identify organizations with active immigration programs before you apply.
What is the prevailing wage requirement for sponsored Clinical Operations Coordinator jobs?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.
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