Clinical Development Specialist Jobs in USA with Visa Sponsorship
Clinical Development Specialists manage clinical trial operations for pharmaceutical, biotech, and medical device companies, roles that routinely qualify for H-1B visa and O-1 visa sponsorship. Most positions require a life sciences degree, and many employers are experienced sponsors. For detailed occupation requirements, see the O*NET profile.
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INTRODUCTION
A Clinical Development Specialist will work with Quest Medical and Laboratory Directors and their staff, Clinical Development management and staff, external scientific and clinical administrative staff and external vendors to support S & I clinical development research efforts. The Clinical Development Specialist is responsible for oversight of all operational aspects of clinical studies including; clinical study initiation activities, site selection and training efforts, study documentation, study site monitoring, query resolution, data monitoring and data flow, flow of specimens between sites, study site payment activities, study close down. This person will report to Clinical Development Management.
This professional can work in a remote capacity and must be located in the US.
Quest Diagnostics honors our service members and encourages veterans to apply.
ROLE AND RESPONSIBILITIES
- Develop study initiation and management plans with Clinical Development Management and Principal Investigators (both internal and external).
- Assist with assessing site/investigator interest and feasibility, site selection, initiation/training, provisioning of study materials to study sites, site monitoring and resolution of study-related problems.
- Track study progress, adherence to protocol, data submission, deviations and discrepancies.
- Communicate with sites on a regular basis, send updates on current status of study enrollment and follow study-related queries until resolved.
- Work with Biorepository staff to ensure efficient and accurate study sample management and relay information on sample transfer to/from analysis lab personnel.
- Provide sample handling expertise and guidance during project design and operation.
- Build, populate and maintain study document folders.
- Proactively look for and communicate potential program risks to Clinical Development Management/PI and provide possible mitigation strategies.
- Work with data management to design Case Report Forms (CRFs) and resolve data discrepancies.
- Work as a research services manager for select sites and external vendors. Monitors routing and status of contracts and agreements.
- Assist in subject recruitment and conduct informed consenting as needed.
- Collaborate and coordinate activities with other Coordinators to ensure continuity of study management.
- Collaborate effectively with all internal and external Clinical Development partners and customers.
- Coordinate payments to study sites and vendors and subject reimbursements.
- Perform remote or on-site monitoring visits.
- Assist with and oversee efforts provided by third party vendors such as CROs.
- Co-manage a study status database with other Coordinators.
- Assess resource demands and report needs to Clinical Development Management to assure timely achievement of program deliverables.
- Coordinate deidentification of Quest samples and transportation to external collaborators.
- Perform other duties as assigned.
BASIC QUALIFICATIONS
Bachelor’s Degree preferably in health, life sciences with three or more years experience working in the capacity of a clinical research study coordinator or a minimum of five years of clinical research experience or five years’ experience in a similar capacity.
Working knowledge of Good Clinical Practices (GCP’s) and International Conference on Harmonization (ICH) guidelines and/or Clinical Laboratory Improvement Amendments (CLIA). Have or complete current CITI training for Human Subjects Research.
PREFERRED QUALIFICATIONS
- Demonstrate effective written and verbal communication skills.
- Ability to set priorities and address high priority tasks as appropriate.
- Demonstrate strong problem-solving skills, adapt current job skills and learn novel approaches to solve problems.
- Able to drive innovation by embracing diversity and change.
- Possess outstanding organizational skills and the ability to work on multiple projects at one time.
- Proficient in the use of Microsoft Office.
- Possess a fundamental knowledge of clinical and scientific research.
Travel: Up to 20%
Equal Opportunity Employer: Race/Color/Sex/Sexual Orientation/Gender Identity/Religion/National Origin/Disability/Vets or any other legally protected status.
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Get Access To All JobsTips for Finding Visa Sponsorship as a Clinical Development Specialist
Target biotech and pharma employers directly
Large pharmaceutical companies and contract research organizations file H-1B petitions regularly. Filtering for employers with a documented sponsorship history significantly improves your odds of landing an interview that leads to a visa offer.
Confirm your degree field aligns with the role
H-1B specialty occupation requires a degree in a directly related field. A background in nursing, biology, pharmacy, or clinical research is typically accepted. A general business degree alone may not satisfy USCIS requirements for this role.
Highlight clinical trial experience in your application
Employers sponsoring visas for this role want candidates who can justify the investment. Specific experience with Phase II or Phase III trials, protocol development, or GCP compliance strengthens both your application and the specialty occupation petition.
Ask about sponsorship before the final interview round
Many clinical development teams are open to sponsoring but haven't formalized a policy. Raising the question early, framed around your timeline and authorization status, helps both sides avoid late-stage surprises during the offer process.
Consider CRO roles as a pathway in
Contract research organizations hire Clinical Development Specialists at high volume and frequently sponsor H-1B visas. Joining a CRO builds trial experience fast and positions you well for direct pharma or biotech roles that sponsor at the senior level.
Document any regulatory or IND submission experience
Experience with IND applications, FDA correspondence, or clinical study reports signals senior-level value. Employers are more likely to invest in sponsorship for candidates whose specialized knowledge would be difficult to replace with a locally authorized hire.
Frequently Asked Questions
Do Clinical Development Specialist roles typically qualify for H-1B sponsorship?
Yes. Clinical Development Specialist positions generally meet the H-1B visa specialty occupation standard because they normally require at least a bachelor's degree in a specific field such as biology, pharmacy, nursing, or clinical research. USCIS has consistently recognized clinical research roles as qualifying, particularly when the job description ties specific duties to specialized academic training.
What degree do I need for a Clinical Development Specialist visa petition?
Most H-1B petitions for this role are supported by degrees in life sciences, nursing, pharmacy, biomedical sciences, or clinical research. A general science degree may work if your coursework aligns with the specific role requirements. A business or unrelated degree alone is unlikely to satisfy the specialty occupation requirement without significant supplemental qualifications.
Are there visa options besides the H-1B for this role?
Yes. If you have an extensive publication record, clinical trial leadership, or significant industry recognition, the O-1A visa for extraordinary ability is worth exploring. Australians may qualify for the E-3 visa, which follows a similar specialty occupation standard as the H-1B but has a separate annual allocation and no lottery.
How competitive is the H-1B lottery for clinical development roles?
The H-1B lottery applies to all cap-subject petitions regardless of job title. However, clinical development positions at hospitals, nonprofit research institutions, or universities may qualify for the cap exemption, bypassing the lottery entirely. It's worth verifying an employer's cap-exempt status before the registration window opens each March.
Where can I find Clinical Development Specialist jobs that offer visa sponsorship?
Migrate Mate is built specifically for international job seekers and filters for employers willing to sponsor. Browsing Clinical Development Specialist listings on Migrate Mate lets you focus on roles where sponsorship is part of the hiring process rather than an afterthought, which saves significant time during your job search.
What is the prevailing wage requirement for sponsored Clinical Development Specialist 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.