H-1B Visa Clinical Research Manager Jobs
Clinical Research Manager roles qualify as H-1B visa specialty occupations under the life sciences SOC codes, requiring at least a bachelor's degree in a directly related field. Large pharma, CROs, and academic medical centers are consistent H-1B sponsors. The 85,000-slot annual cap and lottery mean timing your job search matters.
Find H-1B Visa Clinical Research Manager JobsOverview
Showing 5 of 2,489+ Clinical Research Manager jobs
See all 2,489+ Clinical Research Manager Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Clinical Research Manager roles.
Get Access To All JobsINTRODUCTION
The Emmanuel Mignot Lab at Stanford University is seeking a Clinical Research Coordinator 2 to conduct clinical research and work independently on progressively more complex projects/assignments. Independently manage significant and key aspects of a large study or all aspects of one or more small research studies.
DESIRED QUALIFICATIONS:
- 3+ years of experience working in Sleep Medicine clinical trials.
- Experience with clinical trial study start-up and close-out activities.
- Previous experience serving as a study lead for a clinical trial that underwent an FDA audit.
- Direct participation and experience supporting an FDA audit.
- Strong knowledge and experience maintaining Investigator Site Files (ISF) and ensuring proper documentation and organization.
- Strong understanding of clinical trial documentation, regulatory requirements, and study compliance.
- Knowledge of sleep medicine disorders.
- Experience participating in FDA audits.
- Experience training and supervising a group of at least four Clinical Research Assistants (CRCAs).
- Experience participating in study start-up and closeout activities.
- Experience recruiting and retaining complex patient populations in clinical trials.
- Experience using Electronic Data Capture (EDC) systems and vendor portals.
- Experience performing ECGs.
Physical Requirements:
- Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
- Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
- Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.
WORKING CONDITIONS:
- Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.
- May require extended or unusual work hours based on research requirements and business needs.
Core Duties:
- Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
- Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data.
- Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes.
- Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work.
- Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions and respond to requests and questions.
- Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries.
- Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices.
- Develop study budget with staff and principal investigator, identifying standard of care versus study procedures. Track patient and study specific milestones, and invoice sponsors according to study contract.
- Ensure regulatory compliance. Regularly inspect study documents to ensure ongoing regulatory compliance. Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed.
Minimum Education and Experience
Bachelor’s degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.
Knowledge, Skills and Abilities:
- Strong interpersonal skills.
- Proficiency in Microsoft Office and database applications.
- Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
- Knowledge of medical terminology.
Certificates and Licenses Required
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
INTRODUCTION
The Emmanuel Mignot Lab at Stanford University is seeking a Clinical Research Coordinator 2 to conduct clinical research and work independently on progressively more complex projects/assignments. Independently manage significant and key aspects of a large study or all aspects of one or more small research studies.
DESIRED QUALIFICATIONS:
- 3+ years of experience working in Sleep Medicine clinical trials.
- Experience with clinical trial study start-up and close-out activities.
- Previous experience serving as a study lead for a clinical trial that underwent an FDA audit.
- Direct participation and experience supporting an FDA audit.
- Strong knowledge and experience maintaining Investigator Site Files (ISF) and ensuring proper documentation and organization.
- Strong understanding of clinical trial documentation, regulatory requirements, and study compliance.
- Knowledge of sleep medicine disorders.
- Experience participating in FDA audits.
- Experience training and supervising a group of at least four Clinical Research Assistants (CRCAs).
- Experience participating in study start-up and closeout activities.
- Experience recruiting and retaining complex patient populations in clinical trials.
- Experience using Electronic Data Capture (EDC) systems and vendor portals.
- Experience performing ECGs.
Physical Requirements:
- Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
- Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
- Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.
WORKING CONDITIONS:
- Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.
- May require extended or unusual work hours based on research requirements and business needs.
Core Duties:
- Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials.
- Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data.
- Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes.
- Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work.
- Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions and respond to requests and questions.
- Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries.
- Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices.
- Develop study budget with staff and principal investigator, identifying standard of care versus study procedures. Track patient and study specific milestones, and invoice sponsors according to study contract.
- Ensure regulatory compliance. Regularly inspect study documents to ensure ongoing regulatory compliance. Work with principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed.
Minimum Education and Experience
Bachelor’s degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.
Knowledge, Skills and Abilities:
- Strong interpersonal skills.
- Proficiency in Microsoft Office and database applications.
- Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
- Knowledge of medical terminology.
Certificates and Licenses Required
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
See all 2,489+ H-1B Visa Clinical Research Manager Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Clinical Research Manager Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Clinical Research Manager
Verify your degree field matches
H-1B approval for Clinical Research Manager roles hinges on a direct connection between your degree field and the job duties. A degree in public health, biology, or clinical science typically qualifies; a business degree alone often doesn't without documented exceptions.
Target employers with CRO infrastructure
Contract research organizations and academic medical centers file H-1B petitions year-round, not just during cap season. Filtering your search to these employer types through Migrate Mate surfaces sponsors with verified DOL Labor Condition Application filing history for this occupation.
Confirm LCA wage level before accepting offers
Your employer must certify a prevailing wage through an LCA before filing your H-1B. Check the OFLC Wage Search for the wage level tied to Clinical Research Manager roles in your specific metro area so you can spot underpaying offers before they become a filing problem.
Align your offer letter to specialty occupation standards
USCIS scrutinizes Clinical Research Manager petitions for specialty occupation evidence. Ask your employer to document the degree requirement explicitly in the job description and offer letter, not just in the I-129, to reduce RFE risk from the outset.
Use O*NET to build your RFE response kit
If USCIS questions whether your role qualifies as a specialty occupation, O*NET's classification for Medical and Health Services Managers provides DOL-recognized evidence that the position typically requires a bachelor's degree or higher in a specific field.
File during cap season with premium processing
H-1B petitions for cap-subject Clinical Research Manager roles must be registered in March. If your start date is time-sensitive due to OPT expiration or a project milestone, request premium processing so USCIS adjudicates within 15 business days of receipt.
H-1B Visa Clinical Research Manager: Frequently Asked Questions
Does a Clinical Research Manager role qualify as an H-1B specialty occupation?
Yes, provided the position requires at least a bachelor's degree in a directly related field such as clinical science, public health, nursing, or biology. USCIS evaluates each petition individually, so the offer letter and job description must explicitly state the degree requirement. Roles where any bachelor's degree is accepted regardless of field are more likely to receive an RFE.
Which types of employers sponsor H-1B visas for Clinical Research Manager positions?
Pharmaceutical companies, contract research organizations, academic medical centers, and large hospital systems are the most consistent H-1B sponsors for this role. Many have dedicated immigration teams and file petitions annually. You can filter for employers with verified H-1B filing history for life sciences roles on Migrate Mate, which sources data directly from DOL Labor Condition Application records.
How does the H-1B lottery affect my timeline as a Clinical Research Manager candidate?
Cap-subject H-1B petitions are entered into a lottery each March, with a selection rate that has historically been below 30% in recent years. If selected, your employment can start no earlier than October 1. Candidates on OPT or cap-gap should confirm their authorization end date before accepting an offer, since a lottery miss could interrupt employment.
Can I switch employers after my H-1B is approved in a Clinical Research Manager role?
Yes. Under AC21 portability, you can change employers without re-entering the lottery if your I-140 has been approved and your new role is in the same or similar occupational classification. Your new employer must file an H-1B transfer petition, and you can begin working once USCIS receives it, not just after approval. The role must still qualify as a specialty occupation.
What documents should I gather before applying to H-1B-sponsored Clinical Research Manager jobs?
Assemble your academic transcripts, degree certificates, and any credential evaluations if your degree is from outside the U.S. You'll also need a detailed CV documenting clinical research responsibilities, since USCIS may require evidence that prior experience aligns with the specialty occupation definition. If your title is listed in O*NET under Medical and Health Services Managers, that classification supports your petition.