E-3 Visa Clinical Data Specialist Jobs
Clinical Data Specialist roles in the U.S. qualify for E-3 visa sponsorship when the position requires a bachelor's degree in a relevant field such as life sciences, statistics, or health informatics. The E-3 runs in two-year increments with no lottery and no cap, making it a practical path for Australian professionals with clinical trial or regulatory data experience.
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Get Access To All JobsAs a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.
Job Location (Full Address):
601 Elmwood Ave, Rochester, New York, United States of America, 14642
Opening:
Worker Subtype:
Regular
Time Type:
Full time
Scheduled Weekly Hours:
40
Department:
400089 Dev & Behav Pediatrics
Work Shift:
UR - Day (United States of America)
Range:
UR URG 107
Compensation Range:
$47,972.00 - $67,161.00
The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.
Responsibilities:
Assumes responsibility for the data management of clinical research protocols. Coordinates with the investigational faculty, clinical trial office staff, and sponsor-designated contacts to resolve data inquiries as needed. Formulates and organizes data entry plans to manage assigned caseloads. Responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, adherence to Standard Operating Procedures (SOPs), and all applicable regulations and guidelines to ensure timely, accurate and compliant data reporting.
ESSENTIAL FUNCTIONS
- Assists in conducting quality checks for data accuracy with data source records as assigned. Reviews medical records for prospective clinical trial patients in conjunction with study eligibility parameters to assist with enrollment.
- Partners with the primary point of contact to provide data status reports and ensure protocol data objectives are scheduled appropriately. Manages a workload of studies commensurate to level of experience. Answers data clarifications for each study. Schedules and meets with study monitors and ensures 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. Ensures clinical issues from monitoring reports are addressed and closed out before the next monitoring visit. Ensures all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines. Prepares data status update reports to be presented routinely at PI Oversight meetings. Extracts and prepares drug safety profile information for annual reports. Prepares relevant information for DSMC reports as required and requested. Observes for deviations and acts to minimize them. Reports deviations when they occur, addressing adverse events with supervision.
- Maintains study binders and filings according to protocol requirements and department policy. Prepares source documentation logs for review by trial investigators by extracting this information from available source documents. Updates data and safety related information in OnCore and collaborates with the trial investigators for review and submission to the applicable sponsor(s) and regulatory authorities. Maintains screening, enrollment, and other sponsor and/or protocol specific logs.
- Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines. Adheres to all UR, Wilmot, and department policies and procedures.
- Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies. Maintains CITI and Conflict of Interest (COI) certification and renewal as required. Gains knowledge in medical research terminology. Continues to gain proficiency in UR-specific research software needed to manage clinical research protocols. Participates in protocol-related training as required.
Other duties as assigned.
MINIMUM EDUCATION & EXPERIENCE
Bachelor's degree and 1 year of relevant experience required
Or equivalent combination of education and experience
KNOWLEDGE, SKILLS AND ABILITIES
- Skill in completing assignments accurately and with attention to detail required
- Ability to understand and follow standard research protocols and procedures required
- Ability to process and handle confidential information with discretion required
- Commitment to the University’s core values required
- Ability to work independently and/or in a collaborative environment required
- Understands and follows data integrity standards and processes as outlined in the Code of Federal Regulations (CFR), Good Clinical Practices (GCP) and Good Documentation Practices (GDP) required
- Strong interpersonal, communication, and organizational skills required
- Highly collaborative, works well in teams required
- Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet required
The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University’s Mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.
As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.
Job Location (Full Address):
601 Elmwood Ave, Rochester, New York, United States of America, 14642
Opening:
Worker Subtype:
Regular
Time Type:
Full time
Scheduled Weekly Hours:
40
Department:
400089 Dev & Behav Pediatrics
Work Shift:
UR - Day (United States of America)
Range:
UR URG 107
Compensation Range:
$47,972.00 - $67,161.00
The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.
Responsibilities:
Assumes responsibility for the data management of clinical research protocols. Coordinates with the investigational faculty, clinical trial office staff, and sponsor-designated contacts to resolve data inquiries as needed. Formulates and organizes data entry plans to manage assigned caseloads. Responsible for the compilation, registration and submission of data, monitoring compliance with the protocol, adherence to Standard Operating Procedures (SOPs), and all applicable regulations and guidelines to ensure timely, accurate and compliant data reporting.
ESSENTIAL FUNCTIONS
- Assists in conducting quality checks for data accuracy with data source records as assigned. Reviews medical records for prospective clinical trial patients in conjunction with study eligibility parameters to assist with enrollment.
- Partners with the primary point of contact to provide data status reports and ensure protocol data objectives are scheduled appropriately. Manages a workload of studies commensurate to level of experience. Answers data clarifications for each study. Schedules and meets with study monitors and ensures 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. Ensures clinical issues from monitoring reports are addressed and closed out before the next monitoring visit. Ensures all study requirements are documented and meet both internal and external regulations in accordance with protocol guidelines. Prepares data status update reports to be presented routinely at PI Oversight meetings. Extracts and prepares drug safety profile information for annual reports. Prepares relevant information for DSMC reports as required and requested. Observes for deviations and acts to minimize them. Reports deviations when they occur, addressing adverse events with supervision.
- Maintains study binders and filings according to protocol requirements and department policy. Prepares source documentation logs for review by trial investigators by extracting this information from available source documents. Updates data and safety related information in OnCore and collaborates with the trial investigators for review and submission to the applicable sponsor(s) and regulatory authorities. Maintains screening, enrollment, and other sponsor and/or protocol specific logs.
- Keeps current with all federal, state, sponsor, and institutional policies and laws, standard operating procedures, and guidelines. Adheres to all UR, Wilmot, and department policies and procedures.
- Maintains requisite skills and mandatory training in safety, equality, responsible conduct of research, continuing education, and research competencies. Maintains CITI and Conflict of Interest (COI) certification and renewal as required. Gains knowledge in medical research terminology. Continues to gain proficiency in UR-specific research software needed to manage clinical research protocols. Participates in protocol-related training as required.
Other duties as assigned.
MINIMUM EDUCATION & EXPERIENCE
Bachelor's degree and 1 year of relevant experience required
Or equivalent combination of education and experience
KNOWLEDGE, SKILLS AND ABILITIES
- Skill in completing assignments accurately and with attention to detail required
- Ability to understand and follow standard research protocols and procedures required
- Ability to process and handle confidential information with discretion required
- Commitment to the University’s core values required
- Ability to work independently and/or in a collaborative environment required
- Understands and follows data integrity standards and processes as outlined in the Code of Federal Regulations (CFR), Good Clinical Practices (GCP) and Good Documentation Practices (GDP) required
- Strong interpersonal, communication, and organizational skills required
- Highly collaborative, works well in teams required
- Proficient in MS Office (e.g. Word, Excel, and PowerPoint), email, internet required
The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University’s Mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.
See all E-3 Visa Clinical Data Specialist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new E-3 Visa Clinical Data Specialist Jobs.
Get Access To All JobsTips for Finding E-3 Visa Sponsorship as a Clinical Data Specialist
Translate your AHPRA credentials for U.S. employers
Clinical data roles often require demonstrated familiarity with FDA Part 11 and ICH E6 standards. Frame your Australian regulatory experience explicitly against these U.S. benchmarks in your resume so hiring managers can assess specialty occupation fit without guesswork.
Target sponsors with active IND or NDA pipelines
Pharma and CRO employers running active Investigational New Drug or New Drug Application submissions consistently need clinical data specialists and have established E-3 visa sponsorship workflows. Focus your search on companies in Phase II or Phase III trial stages.
Confirm your role meets specialty occupation requirements
The E-3 requires a theoretical and practical application of highly specialized knowledge. For clinical data roles, your offer letter should specify that a degree in life sciences, biostatistics, or health informatics is required, not merely preferred, to satisfy DOL's specialty occupation standard.
Request the LCA before your start date is set
Your employer must file a Labor Condition Application with DOL and receive certification before you can attend your consulate appointment. Build at least two to three weeks of LCA processing time into your negotiated start date so the timeline doesn't create a gap.
Use Migrate Mate's E-3 filing service to handle your LCA and visa paperwork
Once you have a job offer, Migrate Mate's E-3 filing service manages the LCA submission, DS-160 preparation, and consulate documentation so you're not coordinating between your employer's HR team and U.S. consular requirements independently.
Prepare your clinical systems experience for the consular interview
Officers verify that your qualifications match the offered role. Bring documentation of your experience with clinical data management systems such as Medidata Rave, Oracle Clinical, or Veeva Vault alongside your degree transcript to support your specialty occupation claim at the interview.
E-3 Visa Clinical Data Specialist: Frequently Asked Questions
How do I find Clinical Data Specialist jobs with E-3 visa sponsorship?
Migrate Mate is the most direct way to search for Clinical Data Specialist roles where employers are already open to E-3 sponsorship. Standard job boards surface roles without filtering for visa willingness, which wastes time. Migrate Mate focuses specifically on E-3-eligible positions for Australian professionals, so you're reaching employers who understand the process.
How much does it cost to get an E-3 visa?
Migrate Mate's E-3 filing service covers the entire process for $499, including the Labor Condition Application, visa document preparation, and consulate appointment guidance. Traditional immigration lawyers charge $2,000–$5,000+ for the same work. The E-3 has less paperwork than most work visas, so paying thousands for legal help is usually unnecessary.
Does a Clinical Data Specialist role qualify as a specialty occupation for the E-3?
Yes, provided the position requires at minimum a bachelor's degree in a specific field such as life sciences, biostatistics, clinical research, or health informatics. The role must involve applying specialized theoretical knowledge, not just data entry. If the job description says a degree is preferred rather than required, work with your employer to strengthen the language before the LCA is filed with DOL.
How does the E-3 compare to the H-1B for Clinical Data Specialist positions?
The E-3 has no annual lottery and no numerical cap, so you can apply at any time of year and receive a decision within weeks rather than waiting for a once-a-year selection event. H-1B visa registration is capped at 85,000 per fiscal year with a randomized lottery, meaning qualified applicants are routinely excluded. For Australian nationals, the E-3 is a substantially more reliable path to a U.S. clinical data role.
Can I switch employers while on an E-3 as a Clinical Data Specialist?
Yes, but each new employer must file a fresh LCA with DOL and you'll need a new E-3 visa stamp if yours was issued for your previous employer. You can begin work with the new employer once the LCA is certified and your new visa is issued at a consulate. There's no portability provision for the E-3 equivalent to H-1B's AC21 rule, so plan the transition timeline carefully.