OPT Clinical Development Specialist Jobs
Clinical Development Specialist jobs are a strong fit for F-1 OPT students with degrees in life sciences, clinical research, or public health. Most roles qualify as STEM OPT-eligible, giving you up to 36 months of work authorization. Employers in pharma, biotech, and CROs regularly sponsor H-1B visas for this role.
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Get Access To All JobsINTRODUCTION
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.
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.
See all 84+ OPT Clinical Development Specialist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new OPT Clinical Development Specialist Jobs.
Get Access To All JobsTips for Finding OPT Sponsorship as a Clinical Development Specialist
Target CROs and mid-size biotech companies
Contract research organizations and mid-size biotech firms hire Clinical Development Specialists at high volume and have established visa sponsorship pipelines. They process more H-1B petitions annually than most hospitals or academic medical centers and are more accustomed to sponsoring early-career candidates.
Confirm your degree qualifies for STEM OPT extension
Degrees in biology, biochemistry, public health, or clinical research typically qualify for the 24-month STEM OPT extension. Verify your program CIP code with your DSO before accepting a role, since the extension depends on your degree field, not the job title itself.
Frame your clinical research training as a direct match
Employers worry OPT timelines create hiring risk. Address this upfront by emphasizing that your degree directly matches the role, your STEM extension gives up to 36 months total, and the H-1B cap-subject deadline aligns with your authorization window.
Prioritize employers with active IND or NDA submissions
Companies with active Investigational New Drug or New Drug Application submissions have immediate, ongoing need for clinical development staff. These employers are far more likely to sponsor visas because losing a specialist mid-study creates costly regulatory delays they cannot afford.
Get your e-Verify enrollment confirmed before your start date
STEM OPT extension requires your employer to be enrolled in E-Verify. Confirm enrollment during the offer negotiation stage, not after signing. If the employer is not yet enrolled, they can register, but the process takes time and must be completed before your extension is approved.
Use your clinical internships and practicum as negotiating leverage
Any GCP-certified training, IRB experience, or clinical trial coordination from your program demonstrates immediate productivity. Hiring managers sponsoring OPT students need to justify the investment. Concrete study experience reduces perceived risk and strengthens the case for sponsorship.
Clinical Development Specialist OPT: Frequently Asked Questions
Do Clinical Development Specialist roles qualify for the STEM OPT extension?
Most do, but eligibility depends on your degree, not the job title. Degrees in biology, biochemistry, biomedical sciences, public health, or clinical research typically carry STEM-designated CIP codes that qualify. Your DSO confirms eligibility based on your program's CIP code. The job itself must also be directly related to your degree field, which is straightforward for clinical development roles when your background is in life sciences.
How much time do I actually have to work as a Clinical Development Specialist on OPT?
You get 12 months of standard OPT work authorization, plus a 24-month STEM extension if your degree qualifies, for up to 36 months total. That window covers roughly three H-1B lottery cycles, which meaningfully improves your odds of selection before your OPT expires. Filing for the STEM extension early, at least 90 days before your standard OPT expires, protects your work authorization during USCIS processing.
Which types of employers are most likely to sponsor H-1B visas for Clinical Development Specialists?
Contract research organizations, pharmaceutical companies, and biotech firms with active clinical programs sponsor H-1B petitions for this role at the highest rates. Large pharma companies like those running Phase II or III trials have dedicated immigration teams and predictable sponsorship pipelines. You can browse Clinical Development Specialist roles from verified sponsoring employers on Migrate Mate, where listings are filtered specifically for OPT and visa-sponsored positions.
Can I work as a Clinical Development Specialist at a hospital or academic medical center on OPT?
Yes, but verify two things before accepting an offer. First, confirm the employer is enrolled in E-Verify, which is required for STEM OPT. Some smaller hospitals and academic departments are not enrolled and may be unwilling to register. Second, academic medical centers often use contract or grant-funded positions, which can complicate H-1B sponsorship if the funding cycle does not align with visa timelines.
Does a Clinical Development Specialist role qualify as a specialty occupation for H-1B purposes?
Generally yes. The role typically requires at minimum a bachelor's degree in a specific life science or clinical research field, which satisfies the USCIS specialty occupation standard. The key is that the job description must state a degree requirement in a specific field, not just any bachelor's degree. If a posting says a degree in any health-related field is acceptable, that broader language can weaken a specialty occupation argument during adjudication.