H-1B Visa Clinical Development Specialist Jobs
Clinical Development Specialist roles sit squarely within H-1B specialty occupation territory, requiring at minimum a bachelor's degree in a life sciences or clinical field. Pharmaceutical companies, CROs, and biotech firms regularly sponsor H-1B visas for this title, making it one of the more accessible paths for international professionals in clinical operations.
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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 H-1B Visa Sponsorship as a Clinical Development Specialist
Verify your degree aligns with SOC codes
USCIS evaluates specialty occupation based on whether your degree field directly relates to the role. Pull the O*NET profile for Clinical Development Specialists to confirm the listed education requirements match your credentials before applying.
Target CROs with active LCA filing histories
Contract Research Organizations file LCAs frequently for clinical roles across multiple sites. Use the OFLC Wage Search to identify CROs that have certified LCAs for Clinical Development Specialist positions, which signals active sponsorship infrastructure.
Use Migrate Mate to find verified sponsors
Filter Clinical Development Specialist openings by employers with H-1B filing history using Migrate Mate. This surfaces companies that have already navigated the sponsorship process for this specific role, not just employers open to it in theory.
Confirm employer size before salary negotiations
DOL prevailing wage levels for clinical development roles vary by geography and employer classification. Knowing whether your prospective employer qualifies as H-1B dependent affects how tightly the offered wage must align with the LCA-certified prevailing wage.
Request an LCA copy before your start date
Your employer must post the certified LCA at the worksite and provide you a copy. Confirm this happens at least ten business days before your employment begins, as USCIS can audit compliance and gaps can complicate future renewals.
Account for petition timing around protocol timelines
Clinical development roles often start mid-study cycle. If your offer letter ties your start date to a specific protocol phase, make sure your employer files the I-129 early enough to allow standard USCIS processing, which currently runs several months.
Clinical Development Specialist jobs are hiring across the US. Find yours.
Find Clinical Development Specialist JobsClinical Development Specialist H-1B Visa: Frequently Asked Questions
Does a Clinical Development Specialist role qualify as an H-1B specialty occupation?
Yes. Clinical Development Specialist positions typically require a bachelor's degree or higher in a life sciences field such as biology, pharmacology, nursing, or clinical research. USCIS classifies this as a specialty occupation when the employer's job requirements and the role's industry norms both require that specific degree. Roles requiring a generic degree in any field can face RFE scrutiny, so the job description wording matters significantly.
Which types of employers most commonly sponsor H-1B visas for this role?
Pharmaceutical manufacturers, biotechnology companies, Contract Research Organizations, and academic medical centers are the most consistent H-1B sponsors for Clinical Development Specialists. CROs in particular file high volumes of LCAs for this title across therapeutic areas. You can browse openings from verified sponsors on Migrate Mate, which filters listings by employers with documented H-1B filing history.
How does the prevailing wage requirement affect my offer negotiation?
Your employer must pay you at least the DOL prevailing wage for your job title, level, and work location, as certified in the LCA. If the offered salary falls below the wage level on the LCA, the petition is non-compliant. Use the OFLC Wage Search to look up wage levels for Clinical Development Specialist by geography before entering negotiations so you understand the floor your employer is legally committed to meeting.
Can I transfer my H-1B to a new clinical employer mid-study?
Yes. H-1B portability under AC21 allows you to start working for a new employer once the transfer petition is filed, without waiting for approval, as long as your current H-1B has been approved for at least 180 days. The new employer must file a new I-129 and LCA. Clinical development roles can involve multi-year studies, but the visa transfer itself is independent of where you are in a protocol cycle.
What documentation strengthens an H-1B petition for this role?
A detailed job description linking clinical development duties to your specific degree field, your academic transcripts, and any protocol or therapeutic area certifications are the core supporting documents. If your degree is from outside the U.S., a credential evaluation from a NACES-member evaluator is typically required. USCIS also looks favorably on evidence that the employer routinely hires degree holders in your exact field for this title.
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