H-1B Visa Study Start Up Jobs
Study Start Up roles sit at the intersection of clinical research coordination and regulatory compliance, two areas where H-1B visa specialty occupation requirements are consistently met. Employers in this space regularly file LCAs and sponsor H-1B transfers, making it a viable target for skilled professionals seeking long-term U.S. work authorization.
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Responsible for managing the startup activities of clinical trials. Collaborates with internal and external stakeholders with responsibility for protocol activation in alignment with departmental and D-HH goals. Serves as the primary responsible party and point of contact during clinical research trial feasibility, planning, and implementation stages up until the point of site activation.
Responsibilities
- Organizes and manages implementation of activities required for the study activation process, including, but not limited to feasibility, committee approvals, and regulatory information.
- Leads study site selection and start-up activities.
- Responsible for tracking progress of all studies in the department activation pipeline and meets with the research teams to review the studies’ progress and determine plan of action to ensure study startup is not delayed.
- Meets with Regulatory team to review progress of committee submissions.
- Coordinates and attends all Resource Meetings held with the Clinical Trials Office and study team members. Ensures follow-up action items are progressing in a timely manner.
- May assist with the determination of department personnel time for study budgets.
- Prepares or facilitates the creation of study patient calendars in the clinical trials management system.
- Works with ancillary departments (e.g. pathology, radiology, research laboratory, investigational pharmacy) to ensure all necessary evaluations, documentation, and processes are provided and/or completed to facilitate study activation.
- Tracks and manages the activation process and collaborates with stakeholders to assure timely resolution of problems and/or delays.
- Routinely reviews site metrics and evaluates current procedures for process improvement opportunities.
- Reports out departmental activation metrics as needed.
- Prepares and submits study documents to study sponsors and any applicable regulatory agencies or oversight committees, as necessary.
- May be assigned to data collection for patients in long-term follow-up.
- Performs other duties as required or assigned.
Qualifications
Bachelor’s degree with 5 years of clinical research experience, or the equivalent in education and experience, required.
- Excellent organizational, writing, and office software skills required.
- Excellent oral communication and interpersonal skills.
- Previous project related work involving complex scheduling and communications preferred.
- Maintains a working knowledge of relevant Federal Drug Administration (FDA) and International Conference on Harmonization (ICH) regulations and human subject’s protection requirements.
Required Licensure/Certifications
None
Remote: Hybrid Remote
Area of Interest: Professional/Management
Pay Range: $62,296.00/Yr. - $96,553.60/Yr. (Based on 40 hours per week, otherwise pro rata)
FTE/Hours per pay period: 1.00 - 1.00 - 40 hrs/week
Shift: Day
Job ID: 41736
Dartmouth Health offers a total compensation package that includes a comprehensive selection of benefits. Our Core Benefits include medical, dental, vision and life insurance, short and long term disability, paid time off, and retirement plans. Click here for information on these benefits and more: Benefits | DHMC and Clinics Careers
Dartmouth Health is an Equal Opportunity and Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy-related conditions), sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, veteran or military status, or any other status protected by applicable federal, state, or local law.
Dartmouth Health provides reasonable accommodations to qualified individuals with disabilities and to applicants and employees with sincerely held religious beliefs in accordance with applicable law. Applicants who require an accommodation during the application or interview process may contact talentacquisition@hitchcock.org for assistance.
Overview
Responsible for managing the startup activities of clinical trials. Collaborates with internal and external stakeholders with responsibility for protocol activation in alignment with departmental and D-HH goals. Serves as the primary responsible party and point of contact during clinical research trial feasibility, planning, and implementation stages up until the point of site activation.
Responsibilities
- Organizes and manages implementation of activities required for the study activation process, including, but not limited to feasibility, committee approvals, and regulatory information.
- Leads study site selection and start-up activities.
- Responsible for tracking progress of all studies in the department activation pipeline and meets with the research teams to review the studies’ progress and determine plan of action to ensure study startup is not delayed.
- Meets with Regulatory team to review progress of committee submissions.
- Coordinates and attends all Resource Meetings held with the Clinical Trials Office and study team members. Ensures follow-up action items are progressing in a timely manner.
- May assist with the determination of department personnel time for study budgets.
- Prepares or facilitates the creation of study patient calendars in the clinical trials management system.
- Works with ancillary departments (e.g. pathology, radiology, research laboratory, investigational pharmacy) to ensure all necessary evaluations, documentation, and processes are provided and/or completed to facilitate study activation.
- Tracks and manages the activation process and collaborates with stakeholders to assure timely resolution of problems and/or delays.
- Routinely reviews site metrics and evaluates current procedures for process improvement opportunities.
- Reports out departmental activation metrics as needed.
- Prepares and submits study documents to study sponsors and any applicable regulatory agencies or oversight committees, as necessary.
- May be assigned to data collection for patients in long-term follow-up.
- Performs other duties as required or assigned.
Qualifications
Bachelor’s degree with 5 years of clinical research experience, or the equivalent in education and experience, required.
- Excellent organizational, writing, and office software skills required.
- Excellent oral communication and interpersonal skills.
- Previous project related work involving complex scheduling and communications preferred.
- Maintains a working knowledge of relevant Federal Drug Administration (FDA) and International Conference on Harmonization (ICH) regulations and human subject’s protection requirements.
Required Licensure/Certifications
None
Remote: Hybrid Remote
Area of Interest: Professional/Management
Pay Range: $62,296.00/Yr. - $96,553.60/Yr. (Based on 40 hours per week, otherwise pro rata)
FTE/Hours per pay period: 1.00 - 1.00 - 40 hrs/week
Shift: Day
Job ID: 41736
Dartmouth Health offers a total compensation package that includes a comprehensive selection of benefits. Our Core Benefits include medical, dental, vision and life insurance, short and long term disability, paid time off, and retirement plans. Click here for information on these benefits and more: Benefits | DHMC and Clinics Careers
Dartmouth Health is an Equal Opportunity and Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy-related conditions), sexual orientation, gender identity or expression, national origin, ancestry, age, disability, genetic information, marital status, veteran or military status, or any other status protected by applicable federal, state, or local law.
Dartmouth Health provides reasonable accommodations to qualified individuals with disabilities and to applicants and employees with sincerely held religious beliefs in accordance with applicable law. Applicants who require an accommodation during the application or interview process may contact talentacquisition@hitchcock.org for assistance.
See all H-1B Visa Study Start Up Jobs
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship in Study Start Up
Map your degree to SOC codes
Study Start Up work typically maps to Clinical Research Coordinator or Regulatory Affairs Specialist SOC codes. Pull the O*NET profile for each to confirm the listed degree requirements align with your credentials before targeting employers.
Prioritize employers with active LCA filings
Contract research organizations and academic medical centers file LCAs regularly for Study Start Up roles. Use the OFLC Wage Search to confirm an employer has filed in your target occupation and geography before applying.
Search verified H-1B sponsors on Migrate Mate
Migrate Mate filters Study Start Up jobs by employers with confirmed H-1B filing history, so you skip companies that won't sponsor. Narrow by location and role type to build a shortlist before outreach.
Get your credentials evaluated early
If your clinical research or life sciences degree is from outside the U.S., get a credential evaluation completed before interviews. Employers and USCIS both need to confirm your degree meets specialty occupation standards for this role.
Clarify LCA timing during the offer stage
Ask the hiring manager whether the employer files the LCA in-house or through outside counsel. In-house filers often move faster, which matters if you're on OPT cap-gap or need to hit the October 1 H-1B start date.
Understand the 60-day portability window
If you're transferring an existing H-1B to a new Study Start Up employer, your new employer can file a concurrent I-129 so you're authorized to start without waiting for approval. Confirm this option before giving notice at your current role.
H-1B Visa Study Start Up: Frequently Asked Questions
Does a Study Start Up role qualify as a specialty occupation for H-1B purposes?
Yes, in most cases. Study Start Up roles require applied knowledge of regulatory submissions, protocol feasibility, and site activation processes that typically demand a bachelor's degree or higher in clinical research, life sciences, or a related field. USCIS evaluates specialty occupation on a case-by-case basis, so your employer's petition needs to document that the specific position requires that degree-level expertise.
Which types of employers commonly sponsor H-1B visas for Study Start Up positions?
Contract research organizations, academic medical centers, hospital networks, and mid-size biotech companies are the most consistent H-1B sponsors for Study Start Up roles. Site management organizations that manage multi-site trials also file regularly. You can find employers with verified H-1B filing history for this role type on Migrate Mate, filtered by location and industry.
Can I transfer my H-1B to a new employer for a Study Start Up role mid-year?
Yes. H-1B portability under AC21 lets you start working for a new employer as soon as the transfer petition is filed with USCIS, without waiting for approval, as long as your current H-1B was approved and you've been in valid status. Your new employer files an I-129 with a certified LCA covering your Study Start Up title and work location.
What documentation strengthens an H-1B petition for a Study Start Up role?
The petition needs an LCA certified by DOL at the correct prevailing wage level, a detailed job description tying the role to specialty occupation criteria, and evidence that the position requires a specific degree field. Clinical research certifications, protocol experience letters from previous employers, and IRB or regulatory training records all help establish that the role isn't a generalist position.
How does the H-1B cap lottery affect Study Start Up job seekers?
Most Study Start Up roles at for-profit employers are subject to the annual H-1B cap, which means your petition enters the lottery held each spring for an October 1 start date. Roles at nonprofit research institutions or universities may qualify for cap-exempt status, letting employers file year-round. USCIS publishes cap-exempt employer categories, and confirming your target employer's status before accepting an offer saves significant planning effort.