Clinical Operations Coordinator Jobs for OPT Students
Clinical Operations Coordinator roles are common OPT employers across hospitals, CROs, and biotech firms. Most positions fall under SOC code 11-9111, supporting OPT STEM extension eligibility for relevant degrees. Your 12-month OPT window starts at employment authorization, so applying early and targeting sponsors actively filing I-129s is essential.
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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 biotech firms first
Contract research organizations like ICON, Syneos, and Medpace sponsor OPT students regularly and hire Clinical Operations Coordinators in volume. Their structured HR processes make visa paperwork more familiar than at smaller clinical sites.
Align your degree to the role clearly
Clinical Operations Coordinator roles typically qualify under public health, biomedical science, or health administration degrees. Make sure your resume explicitly connects your academic background to clinical trial management or healthcare operations to support your OPT authorization.
Raise OPT early, not at the offer stage
Mention your OPT status and timeline during the second interview, not after receiving an offer. Hiring managers in clinical settings can flag concerns early, and addressing your authorization proactively shows preparation rather than creating a last-minute obstacle.
Emphasize regulatory knowledge in your application
Familiarity with ICH-GCP guidelines, IRB submissions, or FDA regulations differentiates OPT candidates from domestic applicants. Employers know clinical compliance expertise takes time to develop, so demonstrating it signals you'll contribute from day one.
Track your OPT end date against hiring timelines
Clinical operations hiring cycles often run eight to twelve weeks. If your OPT expires within six months, prioritize employers actively filing H-1B petitions and apply early enough to leave time for cap-subject lottery registration before your status lapses.
Use your STEM extension if your degree qualifies
Degrees in biological sciences, public health, or health informatics often qualify for a 24-month STEM OPT extension. That extension gives employers a longer runway before H-1B sponsorship is required, which meaningfully improves your chances of securing full sponsorship.
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Get Access To All JobsFrequently Asked Questions
Do Clinical Operations Coordinator jobs commonly sponsor OPT students?
Yes, particularly at contract research organizations, academic medical centers, and mid-size biotech firms. These employers hire Clinical Operations Coordinators in enough volume that their HR and legal teams are already familiar with OPT and H-1B filings. Roles tied to active clinical trials often move quickly, so having your OPT documentation ready before you apply helps. You can browse sponsoring employers on Migrate Mate.
Does a Clinical Operations Coordinator role qualify for STEM OPT extension?
It depends on your degree, not the job title. If your degree is in a STEM-designated field such as biological sciences, public health, health informatics, or biomedical engineering, you can apply for a 24-month STEM OPT extension regardless of your job title. The role itself must still be directly related to your field of study and meet the formal training plan requirements your DSO will need to document.
What visa does an employer typically sponsor after OPT for this role?
The H-1B is the most common path. Clinical Operations Coordinator positions generally qualify as specialty occupations requiring a bachelor's degree in a specific field, which meets the H-1B standard. Some employers at academic medical centers also explore J-1 or TN sponsorship depending on the candidate's nationality. Cap-subject H-1B petitions must be filed in April for an October 1 start, so timing your OPT expiration against that window matters.
Can I work as a Clinical Operations Coordinator on a 60-day grace period?
No. The 60-day grace period after OPT expires is not work-authorized. You cannot begin or continue employment during that window. If your OPT ends between jobs, your new employer's H-1B or other petition would need to cover the gap, or you would need to bridge through cap-exempt employment if eligible. Do not accept a start date that falls outside your authorized period.
What should I include on my resume to stand out for OPT-sponsored Clinical Operations Coordinator roles?
Lead with clinical trial coordination experience, even from internships or research assistant roles. Specific mentions of protocol deviations, site monitoring visits, CTMS platforms, or IRB correspondence show practical fluency. If you have GCP certification, list it prominently. Employers sponsoring OPT expect candidates who can reduce onboarding time, so concrete technical competencies matter more than generalist clinical descriptions.
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