Trial Master File Jobs in USA with Visa Sponsorship
Trial Master File specialists manage the regulatory document backbone of clinical trials, making them a consistent hire at pharmaceutical companies, CROs, and biotech firms that routinely sponsor H-1B visa and TN visas. A degree in life sciences, health informatics, or a related field typically satisfies specialty occupation requirements for this role.
Find Trial Master File JobsOverview
Showing 5 of 16+ Trial Master File jobs
See all Trial Master File Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Trial Master File roles.
Get Access To All JobsMake banking a Fifth Third better®
We connect great people to great opportunities. Are you ready to take the next step? Discover a career in banking at Fifth Third Bank.
GENERAL FUNCTION:
Works with Default & Collections Management to organize the delivery of files for various individual loan audit requests.
Responsible and accountable for risk by openly exchanging ideas and opinions, elevating concerns, and personally following policies and procedures as defined. Accountable for always doing the right thing for customers and colleagues, and ensures that actions and behaviors drive a positive customer experience. While operating within the Bank’s risk appetite, achieves results by consistently identifying, assessing, managing, monitoring, and reporting risks of all types.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Attend audit meetings and execute on document requests from staff and LOB owners.
- Work from checklists to prepare files for audit or quality review.
- Make copies, ensure required documents are included, etc.
- Responsible for preparation, quality check and delivery of regulatory file submissions in accordance with agency requirements and company standards.
- Organize and maintain file components associated with a regulatory audit. This may include, but not exclusive to, setting up file templates, scanning, printing and indexing.
- Responsible for all aspects of the file submission process and/or submission of file components for internal review and signoff, and for submission to regulatory authorities. This includes all operational tasks including formatting, editing, reviewing, publishing and archiving (paper and electronic) as applicable.
- Ensure and confirm that all documentation and records are available for review and are in order. This may include but is not limited to the foreclosure and bankruptcy process.
- Communicate effectively with clients via phone, email and client websites to ensure all information needed is received to expedite the audit process.
- Random spot checks of files pulled for audit for accuracy.
- Create inventory list of items delivered to audit requestor; track delivery and receipt.
- Organize delivery of requested docs, files, etc. to Audit or Quality Teams.
- Perform random monthly checks of files for accuracy and content of prepared file.
- Report results of audits, troubled files, etc.
- Identify gaps of audit process to prepare for next audit.
- Enter and retrieve data from Central File Room and foreclosure tracking systems as needed.
- Create and maintain tracking spreadsheets, certification tracking and exception tracking.
- Pull and certify files for review according to pertinent investor requirements.
- Retrieve notes from system notes to augment file documentation as requested.
- Prepare original document for delivery to the collections area so foreclosure proceedings can begin.
- Prepared documents and files for image processing when necessary.
- Assist in cataloging documentation for imaging.
- Operate various office and imaging machines.
- Perform general housekeeping in the department and in file room.
- Meet and maintain production standards for File room activities.
- Perform all work in accordance with established safety procedures.
- Perform any other duties as assigned.
SUPERVISOR RESPONSIBILITIES:
None.
MINIMUM KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:
- High school diploma or equivalent. (Some college preferred).
- Strong organization skills and attention to detail with the ability to prioritize.
- Prior PC experience to include moderate to advanced Excel, Word and Access.
- Ability to work under moderate supervision; self-motivated.
- 1-2 year relevant experience; familiarity with mortgage servicing documents.
- Must be able to work efficiently in DokTrak, Ace, Mortgage Serv, UniFi, and Nautilus.
- Good verbal and written communication, spelling, grammar and typing skills.
- A general expertise of all documents that would be requested by internal and external agencies for compliance reviews.
Audit File Preparation Specialist
At Fifth Third, we understand the importance of recognizing our employees for the role they play in improving the lives of our customers, communities and each other. Our Total Rewards include comprehensive benefits and differentiated compensation offerings to give each employee the opportunity to be their best every day.
The base salary for this position is reflective of the range of salary levels for all roles within this pay grade across the U.S. Individual salaries within this range will vary based on factors such as role, relevant skillset, relevant experience, education and geographic location.
Our extensive benefits programs are designed to support the individual needs of our employees and their families, encompassing physical, financial, emotional and social well-being. You can learn more about those programs on our 53.com Careers page at: https://www.53.com/content/fifth-third/en/careers/benefits.html or by consulting with your talent acquisition partner.
LOCATION
Cincinnati, Ohio 45227
Attention search firms and staffing agencies: do not submit unsolicited resumes for this posting. Fifth Third does not accept resumes from any agency that does not have an active agreement with Fifth Third. Any unsolicited resumes – no matter how they are submitted – will be considered the property of Fifth Third and Fifth Third will not be responsible for any associated fee.
Fifth Third Bank, National Association is proud to have an engaged and inclusive culture and to promote and ensure equal employment opportunity in all employment decisions regardless of race, color, gender, national origin, religion, age, disability, sexual orientation, gender identity, military status, veteran status or any other legally protected status.
Make banking a Fifth Third better®
We connect great people to great opportunities. Are you ready to take the next step? Discover a career in banking at Fifth Third Bank.
GENERAL FUNCTION:
Works with Default & Collections Management to organize the delivery of files for various individual loan audit requests.
Responsible and accountable for risk by openly exchanging ideas and opinions, elevating concerns, and personally following policies and procedures as defined. Accountable for always doing the right thing for customers and colleagues, and ensures that actions and behaviors drive a positive customer experience. While operating within the Bank’s risk appetite, achieves results by consistently identifying, assessing, managing, monitoring, and reporting risks of all types.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Attend audit meetings and execute on document requests from staff and LOB owners.
- Work from checklists to prepare files for audit or quality review.
- Make copies, ensure required documents are included, etc.
- Responsible for preparation, quality check and delivery of regulatory file submissions in accordance with agency requirements and company standards.
- Organize and maintain file components associated with a regulatory audit. This may include, but not exclusive to, setting up file templates, scanning, printing and indexing.
- Responsible for all aspects of the file submission process and/or submission of file components for internal review and signoff, and for submission to regulatory authorities. This includes all operational tasks including formatting, editing, reviewing, publishing and archiving (paper and electronic) as applicable.
- Ensure and confirm that all documentation and records are available for review and are in order. This may include but is not limited to the foreclosure and bankruptcy process.
- Communicate effectively with clients via phone, email and client websites to ensure all information needed is received to expedite the audit process.
- Random spot checks of files pulled for audit for accuracy.
- Create inventory list of items delivered to audit requestor; track delivery and receipt.
- Organize delivery of requested docs, files, etc. to Audit or Quality Teams.
- Perform random monthly checks of files for accuracy and content of prepared file.
- Report results of audits, troubled files, etc.
- Identify gaps of audit process to prepare for next audit.
- Enter and retrieve data from Central File Room and foreclosure tracking systems as needed.
- Create and maintain tracking spreadsheets, certification tracking and exception tracking.
- Pull and certify files for review according to pertinent investor requirements.
- Retrieve notes from system notes to augment file documentation as requested.
- Prepare original document for delivery to the collections area so foreclosure proceedings can begin.
- Prepared documents and files for image processing when necessary.
- Assist in cataloging documentation for imaging.
- Operate various office and imaging machines.
- Perform general housekeeping in the department and in file room.
- Meet and maintain production standards for File room activities.
- Perform all work in accordance with established safety procedures.
- Perform any other duties as assigned.
SUPERVISOR RESPONSIBILITIES:
None.
MINIMUM KNOWLEDGE, SKILLS AND ABILITIES REQUIRED:
- High school diploma or equivalent. (Some college preferred).
- Strong organization skills and attention to detail with the ability to prioritize.
- Prior PC experience to include moderate to advanced Excel, Word and Access.
- Ability to work under moderate supervision; self-motivated.
- 1-2 year relevant experience; familiarity with mortgage servicing documents.
- Must be able to work efficiently in DokTrak, Ace, Mortgage Serv, UniFi, and Nautilus.
- Good verbal and written communication, spelling, grammar and typing skills.
- A general expertise of all documents that would be requested by internal and external agencies for compliance reviews.
Audit File Preparation Specialist
At Fifth Third, we understand the importance of recognizing our employees for the role they play in improving the lives of our customers, communities and each other. Our Total Rewards include comprehensive benefits and differentiated compensation offerings to give each employee the opportunity to be their best every day.
The base salary for this position is reflective of the range of salary levels for all roles within this pay grade across the U.S. Individual salaries within this range will vary based on factors such as role, relevant skillset, relevant experience, education and geographic location.
Our extensive benefits programs are designed to support the individual needs of our employees and their families, encompassing physical, financial, emotional and social well-being. You can learn more about those programs on our 53.com Careers page at: https://www.53.com/content/fifth-third/en/careers/benefits.html or by consulting with your talent acquisition partner.
LOCATION
Cincinnati, Ohio 45227
Attention search firms and staffing agencies: do not submit unsolicited resumes for this posting. Fifth Third does not accept resumes from any agency that does not have an active agreement with Fifth Third. Any unsolicited resumes – no matter how they are submitted – will be considered the property of Fifth Third and Fifth Third will not be responsible for any associated fee.
Fifth Third Bank, National Association is proud to have an engaged and inclusive culture and to promote and ensure equal employment opportunity in all employment decisions regardless of race, color, gender, national origin, religion, age, disability, sexual orientation, gender identity, military status, veteran status or any other legally protected status.
See all Trial Master File Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Trial Master File roles.
Get Access To All JobsTips for Finding Trial Master File Jobs
Target CROs and pharma companies first
Contract research organizations like ICON, Parexel, and Syneos Health, along with major pharmaceutical companies, sponsor TMF roles regularly. These employers have established immigration infrastructure and sponsor H-1B and TN workers far more consistently than smaller biotech startups.
Highlight your DIA Reference Model knowledge
Familiarity with the DIA TMF Reference Model signals immediate productivity to hiring managers. Employers sponsoring visas want reduced onboarding time, and demonstrating hands-on experience with TMF structure standards makes you a lower-risk hire worth sponsoring.
Certify your eTMF platform experience
Proficiency in electronic TMF systems such as Veeva Vault or Documentum is increasingly expected. Listing specific platforms on your resume and quantifying inspection-readiness outcomes you achieved strengthens your specialty occupation case and improves your sponsorship prospects significantly.
Understand the specialty occupation argument
USCIS requires that your role normally requires a bachelor's degree in a specific field. For TMF specialists, framing your position around regulatory affairs, clinical data management, or health informatics rather than general administration strengthens the H-1B specialty occupation determination considerably.
Canadians and Mexicans should explore TN status
TN visa classification under USMCA covers scientific technicians and certain clinical roles. If your background is in life sciences or health records management, TN status offers a faster, cap-exempt alternative to H-1B with no lottery risk and same-day border processing available.
Use Migrate Mate to filter sponsoring employers
Not every clinical operations job comes with sponsorship. Migrate Mate lists TMF roles specifically from employers with documented H-1B sponsorship history, letting you focus your applications on companies already set up to support your visa rather than discovering that late in the process.
Frequently Asked Questions
Do Trial Master File jobs qualify for H-1B sponsorship?
Yes, TMF specialist roles generally qualify as H-1B visa specialty occupations when they require a bachelor's degree in a specific field such as life sciences, health informatics, regulatory affairs, or clinical research. The critical factor is how the employer defines the position. Roles framed around regulatory compliance and clinical documentation management are stronger candidates than those described as general administrative work. Your employer's HR and legal team will determine the exact specialty occupation argument filed with USCIS.
What degree do I need for visa sponsorship in a TMF role?
Most employers require a bachelor's degree in life sciences, health information management, clinical research, pharmacy, or a closely related field. Degrees in biology, biochemistry, or public health are commonly accepted. A general business or administrative degree is less likely to satisfy USCIS specialty occupation requirements for this role, so degree-field alignment matters. Some employers also accept equivalent combinations of education and direct TMF or regulatory experience when the degree field isn't a perfect match.
Is the TN visa an option for TMF specialists from Canada or Mexico?
It can be, depending on how the role is classified. TN visa categories covering scientific technicians, pharmacists, or clinical laboratory technologists may apply if your educational background and job duties align. TN status has no lottery, no cap, and can be processed at the border for Canadians. However, TN classification is occupation-specific and must fit a defined USMCA category, so confirming the match with your employer's immigration counsel before applying is important.
Which types of employers are most likely to sponsor TMF roles?
Large contract research organizations, global pharmaceutical companies, and mid-size biotechs with active clinical pipelines sponsor TMF positions most consistently. These employers have experienced immigration teams and established processes for H-1B filing. Smaller startups in early-stage development sometimes sponsor but may lack the legal infrastructure for a smooth process. Browse Migrate Mate to find TMF roles specifically from employers with a track record of visa sponsorship.
How does the H-1B lottery affect my chances of getting sponsored for a TMF job?
The regular H-1B cap has a selection rate that has ranged from roughly 25% to 50% in recent years, meaning sponsorship isn't guaranteed even if an employer is willing to file. TMF roles at cap-exempt employers, such as nonprofit research institutions or university-affiliated hospitals, bypass the lottery entirely. If you're already in the U.S. on OPT or another H-1B, a change of employer doesn't require a new lottery selection, which makes your candidacy more straightforward for sponsoring companies.
What is the prevailing wage requirement for sponsored Trial Master File jobs?
U.S. employers sponsoring a visa must pay at least the prevailing wage, which is what workers in the same role, area, and experience level typically earn. The Department of Labor sets this rate to make sure companies aren't hiring foreign workers simply because they'd accept lower pay than a U.S. worker. It varies by job title, location, and experience. You can look up current prevailing wage rates for any occupation and location using the OFLC Wage Search page.