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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Get Access To All JobsINTRODUCTION
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
ROLE AND RESPONSIBILITIES
- Responsible for the delivery of study start-up, initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, BeOne’s SOPs, and local regulations.
Essential Functions of the job:
- Familiar with ICH/GCP, relevant country regulations/guidelines, and SOPs
- Contribute to discussions during the feasibility state of site selection
- Site Start-Up
- Skilled in driving kick-off and completion of tasks from selection through activation, including providing timeline input for site activations
- Leverage and build upon existing site partnership data to execute start-up efficiently, reducing cycle times wherever possible
- ICF/Submissions
- Skilled in document management/negotiation and leveraging site relationships to achieve submission targets from start-up through close-out
- Skilled in document preparation and submission to central IRB to ensure timely reviews
- Ensure collection and review of essential documents
- Complete SSU data entry in CTMS
- Complete timely and quality eTMF filing
- Support in the development of local workflows to streamline output and deliverables
- Contribute to the ongoing improvement of SSU infrastructure in North America
- Perform additional tasks as assigned or required to achieve project, functional, departmental, or corporate goals
Supervisory Responsibilities:
- Not applicable
BASIC QUALIFICATIONS
- Bachelor’s degree or higher in a scientific or healthcare discipline preferred
- Minimum of 3 years of progressive experience in clinical research and clinical operations preferably within the biotech, pharmaceutical sector, CRO, or clinical site environment
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
COMPENSATION
- Salary Range: $83,800.00 - $113,800.00 annually
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer. BeOne 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.
INTRODUCTION
BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
ROLE AND RESPONSIBILITIES
- Responsible for the delivery of study start-up, initial and ongoing submissions within established timelines with high quality and in accordance with ICH/GCP, BeOne’s SOPs, and local regulations.
Essential Functions of the job:
- Familiar with ICH/GCP, relevant country regulations/guidelines, and SOPs
- Contribute to discussions during the feasibility state of site selection
- Site Start-Up
- Skilled in driving kick-off and completion of tasks from selection through activation, including providing timeline input for site activations
- Leverage and build upon existing site partnership data to execute start-up efficiently, reducing cycle times wherever possible
- ICF/Submissions
- Skilled in document management/negotiation and leveraging site relationships to achieve submission targets from start-up through close-out
- Skilled in document preparation and submission to central IRB to ensure timely reviews
- Ensure collection and review of essential documents
- Complete SSU data entry in CTMS
- Complete timely and quality eTMF filing
- Support in the development of local workflows to streamline output and deliverables
- Contribute to the ongoing improvement of SSU infrastructure in North America
- Perform additional tasks as assigned or required to achieve project, functional, departmental, or corporate goals
Supervisory Responsibilities:
- Not applicable
BASIC QUALIFICATIONS
- Bachelor’s degree or higher in a scientific or healthcare discipline preferred
- Minimum of 3 years of progressive experience in clinical research and clinical operations preferably within the biotech, pharmaceutical sector, CRO, or clinical site environment
Global Competencies
When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.
- Fosters Teamwork
- Provides and Solicits Honest and Actionable Feedback
- Self-Awareness
- Acts Inclusively
- Demonstrates Initiative
- Entrepreneurial Mindset
- Continuous Learning
- Embraces Change
- Results-Oriented
- Analytical Thinking/Data Analysis
- Financial Excellence
- Communicates with Clarity
COMPENSATION
- Salary Range: $83,800.00 - $113,800.00 annually
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
We are proud to be an equal opportunity employer. BeOne 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact accommodationsus@beonemed.com.
See all 31+ H-1B Visa Study Start Up Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Study Start Up Jobs.
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.