H-1B Visa Clinical Data Specialist Jobs
Clinical Data Specialist roles qualify as H-1B visa specialty occupations under the life sciences and health informatics categories, typically requiring a bachelor's degree in biostatistics, health information management, or a related field. Sponsors file your LCA with DOL before submitting Form I-129 to USCIS, making employer selection critical.
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Get Access To All JobsCurrent Employees:
If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position, please review this tip sheet.
The Department of Surgery is currently seeking a temporary Clinical Research Data Specialist to work part time hours in Miami.
CORE JOB SUMMARY
The Clinical Research Data Specialist assists in creating, updating, and maintaining research charts and case report forms, including regulatory related issues, in accordance with department standard operating procedures, under the supervision of the Principal Investigator (PI) and supervisor. The Clinical Research Data Specialist is responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, adherence to SOPs, and all applicable regulations and guidelines.
CORE JOB FUNCTIONS
- Extracts clinical data and research data from electronic medical records and other sources and enters this data in the clinical paper-based or electronic data capture system for each assigned study.
- Manages a workload of studies commensurate to level of experience.
- Answers data clarifications (i.e., data queries) for each study.
- Schedules and meets with study monitors and assures patient cases are ready for each monitor visit and items are addressed after each monitoring visit.
- Develops source data worksheets specific to each assigned study.
- Assures clinical issues from monitoring reports are addressed and closed out before the next monitoring visit.
- Assures all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines.
- Maintains logs (i.e., TAS submissions, Velos etc.) in a timely manner according to department SOPs.
- Participates in site initiation visits (SIV), monitoring visits and participates in site disease group (SDG) team and PI oversight meetings as required.
- Assists multidisciplinary team in research activities.
- Maintains study binders and filings according to protocol requirements and department policy.
- Adheres to all UM and department policies and procedures.
- Compiles patient data for Investigator review to determine patient eligibility for protocol enrollment.
- Maintains screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol specific logs.
- Ensures work environment is organized and functions efficiently. Participates in a collaborative, empowered work environment as demonstrated through teamwork. Demonstrates a level of professional practice that supports the delivery of appropriate care and positive working relationships throughout the medical center.
- Adheres to University and unit-level policies and procedures and safeguards University assets.
This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.
CORE QUALIFICATIONS
- High School Diploma or equivalent/relevant experience, certification or license.
- No previous experience required.
- Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.
- Teamwork: Ability to work collaboratively with others and contribute to a team environment.
- Technical Proficiency: Skilled in using office software, technology, and relevant computer applications.
- Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders.
The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.
UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.
The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.
Job Status: Part time
Employee Type: Temporary
Current Employees:
If you are a current Staff, Faculty or Temporary employee at the University of Miami, please click here to log in to Workday to use the internal application process. To learn how to apply for a faculty or staff position, please review this tip sheet.
The Department of Surgery is currently seeking a temporary Clinical Research Data Specialist to work part time hours in Miami.
CORE JOB SUMMARY
The Clinical Research Data Specialist assists in creating, updating, and maintaining research charts and case report forms, including regulatory related issues, in accordance with department standard operating procedures, under the supervision of the Principal Investigator (PI) and supervisor. The Clinical Research Data Specialist is responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, adherence to SOPs, and all applicable regulations and guidelines.
CORE JOB FUNCTIONS
- Extracts clinical data and research data from electronic medical records and other sources and enters this data in the clinical paper-based or electronic data capture system for each assigned study.
- Manages a workload of studies commensurate to level of experience.
- Answers data clarifications (i.e., data queries) for each study.
- Schedules and meets with study monitors and assures patient cases are ready for each monitor visit and items are addressed after each monitoring visit.
- Develops source data worksheets specific to each assigned study.
- Assures clinical issues from monitoring reports are addressed and closed out before the next monitoring visit.
- Assures all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines.
- Maintains logs (i.e., TAS submissions, Velos etc.) in a timely manner according to department SOPs.
- Participates in site initiation visits (SIV), monitoring visits and participates in site disease group (SDG) team and PI oversight meetings as required.
- Assists multidisciplinary team in research activities.
- Maintains study binders and filings according to protocol requirements and department policy.
- Adheres to all UM and department policies and procedures.
- Compiles patient data for Investigator review to determine patient eligibility for protocol enrollment.
- Maintains screening, enrollment, adverse event, deviation, tumor measurement, concomitant medication, delegation and other sponsor and/or protocol specific logs.
- Ensures work environment is organized and functions efficiently. Participates in a collaborative, empowered work environment as demonstrated through teamwork. Demonstrates a level of professional practice that supports the delivery of appropriate care and positive working relationships throughout the medical center.
- Adheres to University and unit-level policies and procedures and safeguards University assets.
This list of duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary.
CORE QUALIFICATIONS
- High School Diploma or equivalent/relevant experience, certification or license.
- No previous experience required.
- Learning Agility: Ability to learn new procedures, technologies, and protocols, and adapt to changing priorities and work demands.
- Teamwork: Ability to work collaboratively with others and contribute to a team environment.
- Technical Proficiency: Skilled in using office software, technology, and relevant computer applications.
- Communication: Strong and clear written and verbal communication skills for interacting with colleagues and stakeholders.
The University of Miami offers competitive salaries and a comprehensive benefits package including medical, dental, tuition remission and more.
UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean. Our physicians represent more than 100 specialties and sub-specialties, and have more than one million patient encounters each year. Our tradition of excellence has earned worldwide recognition for outstanding teaching, research and patient care. We're the challenge you've been looking for.
The University of Miami is an Equal Opportunity Employer. Applicants and employees are protected from discrimination based on certain categories protected by Federal law.
Job Status: Part time
Employee Type: Temporary
See all H-1B Visa Clinical Data Specialist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Clinical Data Specialist Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Clinical Data Specialist
Verify your degree supports specialty occupation
Your degree field must directly relate to clinical data management, not just data science broadly. A biostatistics, health informatics, or clinical research degree strengthens the specialty occupation argument. A general IT degree may trigger an RFE requiring additional documentation.
Check LCA filings for your exact SOC code
Clinical Data Specialists file under SOC 15-2041 or 29-2099 depending on employer classification. Use the OFLC Wage Search to confirm which code your target employers have used and whether their filed wages align with Level I through IV prevailing rates.
Target CROs and pharma with 21 CFR Part 11 roles
Contract research organizations and pharmaceutical companies with FDA-regulated data systems have genuine business necessity for credentialed clinical data staff. That business necessity record strengthens the specialty occupation justification in your I-129 petition.
Search verified H-1B sponsors on Migrate Mate
Filter by Clinical Data Specialist roles to find employers with documented H-1B filing history in clinical data functions. Migrate Mate surfaces DOL Labor Condition Application data so you're targeting companies that have actually sponsored this role, not just ones open to it.
Negotiate LCA wage level before accepting an offer
USCIS scrutinizes whether your offered salary matches your experience level on the LCA. If an employer files at Level I wages for a role requiring three-plus years of EDC platform experience, expect an RFE. Confirm the wage level classification during offer negotiations, not after.
Register before the April H-1B lottery deadline
USCIS opens H-1B cap registration each March for roughly two weeks. Your employer must register you before that window closes. If your OPT end date falls before October 1, ask HR whether premium processing is available to reduce the gap in work authorization.
H-1B Visa Clinical Data Specialist: Frequently Asked Questions
Does a Clinical Data Specialist 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 biostatistics, health informatics, clinical research, or life sciences. Roles that accept any bachelor's degree regardless of field are harder to qualify. USCIS evaluates the job duties, not just the title, so employers need to document why the specific degree field is required.
Which employers regularly sponsor H-1B visas for Clinical Data Specialists?
Pharmaceutical companies, contract research organizations, academic medical centers, and health technology firms are the most consistent sponsors for this role. You can identify employers with verified filing history by searching on Migrate Mate, which shows DOL Labor Condition Application data by occupation so you're not guessing at sponsorship willingness.
Can I transfer my H-1B to a new clinical data employer without waiting for a new cap slot?
Yes. H-1B portability under AC21 allows you to transfer to a new employer as soon as the new employer files an I-129 transfer petition, as long as your original petition was approvable and your current status is valid. You don't re-enter the lottery. Work authorization at the new employer typically begins on the filing receipt date, not the approval date.
How does prevailing wage apply to Clinical Data Specialist H-1B petitions?
Your employer must pay you at least the prevailing wage for your SOC code, experience level, and work location, as certified through the LCA submitted to DOL before your I-129 petition. Clinical data roles classified under health informatics SOC codes can carry higher prevailing wages than general data entry codes. Use the OFLC Wage Search to verify the applicable wage levels for your target location.
What happens to my H-1B status if my clinical data project ends or my contract is cut short?
You have a 60-day grace period after your last day of employment to find a new sponsor, change status, or prepare to depart. If a new employer files an H-1B transfer petition within those 60 days, you can remain in the U.S. while USCIS adjudicates. Gaps longer than 60 days without an active petition put your status at risk, so starting your job search early is essential.