H-1B Visa Clinical Trial Associate Jobs
Clinical Trial Associate roles sit squarely within H-1B specialty occupation territory, requiring a bachelor's degree in life sciences, pharmacy, or a related field. Sponsors file a Labor Condition Application with DOL before petitioning USCIS, and CROs, pharma companies, and academic medical centers are among the most active H-1B filers in this space.
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Why Sarepta? Why Now?
The promise of genetic medicine has arrived, and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle, central nervous system, and cardiac diseases. In 2023, we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
We’re looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta, we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work, and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:
- Physical and Emotional Wellness
- Financial Wellness
- Support for Caregivers
For a full list of our comprehensive benefits, see our website: https://www.sarepta.com/join-us
The Importance of the Role
The Clinical Trial Associate II, Clinical Operations is a developing professional who supports in the planning, execution, and management of clinical trials.
The Opportunity to Make a Difference
- Coordinates and tracks the distribution and subsequent retrieval of clinical documents, including but not limited to protocols, protocol amendments, IBs, ICF’s, monitoring visits reports, etc.
- Supports maintenance of inspection-ready Trial Master File (TMF) according to ICH-GCP and company SOPs
- Performs quality checks on the study TMF with oversight of study Clinical Operations Lead
- Assists in the preparation of study related documents, i.e., ICF, clinical trial tools and templates, etc.
- Coordinates and tracks clinical trial equipment and supplies
- May coordinate and track shipments of drug supply
- Reviews and tracks vendor invoices against contracts with oversight of study Clinical Operations Lead
- May support and participate in departmental/cross-functional process improvement initiatives
- Coordinates and tracks administrative aspects of contract execution and Purchase Order (PO) generation
- Supports the trial team to produce and distribute study newsletters
- Supports collection and updating of clinical trial insurance
- Assists with various supportive trial activities, i.e., meeting management including agenda distribution and minute taking, internal database maintenance, study team contact list, etc.
- May serve as point of contact for low complexity vendors with oversight of study Clinical Operations Lead
- May support additional ad-hoc activities as agreed with the study Clinical Operations Lead
More about You
- Bachelor’s degree in life sciences or healthcare related field
- 3+ years’ experience in a clinical research related position
- Strong computer skills including knowledge of Excel, Word, PowerPoint, and Outlook
- Solid understanding of the responsibilities and needs of other functions in a clinical trial
- Proven ability to work independently and effectively handle multiple priorities in a fast-paced environment
- Ability to maintain confidentiality of proprietary information expected
- A team player that takes initiative is a must
- Excellent interpersonal skills, strong organizational skills, and effective communication across all levels within an organization
- Proficient written and verbal communication skills
- Position may require some travel
What Now?
We’re always looking for solution-oriented, critical thinkers.
So, if you’re comfortable with ambiguity and candor, relish challenging yourself, and place kindness and integrity at the forefront of how you approach your peers and work, then we encourage you to apply.
LOCATION
This position is hybrid, you will be expected to work on site at one of Sarepta’s facilities in the United States and/or attend Company-sponsored in-person events from time to time.
COMPENSATION
- Salary Range: $86,400 - $108,000 per year
Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.
Candidates must be authorized to work in the U.S.
Sarepta Therapeutics offers a competitive compensation and benefit package.
Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.
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Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Clinical Trial Associate
Verify your degree aligns with the role
USCIS requires your degree field to directly relate to the Clinical Trial Associate position. A biology, pharmaceutical sciences, or nursing degree strengthens your petition. A general business degree paired with no clinical coursework can trigger an RFE.
Target CROs and sponsor-ready pharma employers
Contract research organizations and mid-to-large pharma companies file H-1Bs for CTA roles far more consistently than hospitals or small biotech startups. Search Migrate Mate to filter employers by verified H-1B LCA filing history for this specific occupation.
Check prevailing wage tiers before negotiating offers
Use the OFLC Wage Search to look up Level I through Level IV prevailing wages for your metro area before accepting an offer. Your employer's LCA must certify a wage at or above the applicable level, so knowing the tiers protects you from underpaid petitions.
Get your GCP and IATA certifications documented early
Good Clinical Practice certification and, if your role involves investigational product shipping, IATA dangerous goods training are standard CTA credentials. Having current certificates from an accredited provider on hand speeds up employer petition preparation and strengthens the specialty occupation argument.
Confirm E-Verify enrollment if you're on OPT
If you're transitioning from F-1 OPT to H-1B sponsorship and your role qualifies for STEM OPT, your employer must be E-Verify enrolled. Confirm enrollment status before accepting an offer, since unenrolled employers can't extend your work authorization during the cap-gap period.
Negotiate a premium processing clause into your offer
Standard H-1B adjudication can run several months. Ask your employer to include premium processing in the offer letter before you sign. USCIS processes premium petitions within 15 business days, which matters if your OPT or current status has a hard expiration date.
Clinical Trial Associate jobs are hiring across the US. Find yours.
Find Clinical Trial Associate JobsClinical Trial Associate H-1B Visa: Frequently Asked Questions
Does a Clinical Trial Associate role qualify as an H-1B specialty occupation?
Yes. CTA positions require at minimum a bachelor's degree in life sciences, pharmacy, nursing, or a directly related field, which satisfies USCIS's specialty occupation definition. Employers document this through the job description and LCA. Roles at CROs that require regulatory knowledge, protocol management, and GCP compliance consistently meet the standard, though USCIS may issue an RFE if the degree-to-role connection isn't clearly articulated.
Which types of employers sponsor H-1B visas for Clinical Trial Associate jobs?
Contract research organizations are the largest sponsoring category for CTA roles, followed by mid-to-large pharmaceutical and biotechnology companies and academic medical centers with active clinical research programs. Smaller biotech startups and independent site management organizations sponsor less frequently because of the administrative overhead involved. You can browse verified H-1B-sponsoring employers for this role on Migrate Mate, which filters listings by DOL Labor Condition Application filing history.
Can I change employers mid-H-1B if I get a better CTA offer?
Yes. H-1B portability under AC21 lets you start working for a new employer once they file a non-frivolous H-1B transfer petition on your behalf, as long as your current H-1B has been approved for at least 180 days. You don't have to wait for the transfer to be approved before switching. Your new employer still needs to file a fresh LCA with DOL and submit the I-129 to USCIS before your start date.
How does the H-1B cap and lottery affect Clinical Trial Associate applicants?
Most CTA roles at CROs, pharma companies, and private biotech are subject to the annual H-1B cap of 65,000 regular slots plus 20,000 master's cap exemptions. USCIS runs the lottery in March each year for October 1 start dates. Academic medical centers and nonprofit research institutions may be cap-exempt, meaning they can file year-round without waiting for the lottery. Confirm cap-exempt status with any employer before assuming a guaranteed filing window.
What documentation should I prepare before a CTA employer starts the H-1B petition?
You'll need certified academic transcripts, your diploma, a credential evaluation if your degree is from outside the U.S., current GCP certification, and any other role-relevant certifications such as IATA or therapeutic area training. Your employer's attorney will also need your passport, I-94, and any prior immigration approvals. Having these organized before the LCA filing begins can shorten the overall petition timeline by several weeks.
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