OPT Study Start Up Jobs
Study Start Up roles in clinical research coordinate the activation of new study sites, and they're a strong fit for F-1 OPT students with backgrounds in life sciences, public health, or healthcare administration. Most positions qualify as STEM OPT extensions, giving you up to three years of authorized work.
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Study Start-Up Associate II
Be Part of One Team, One Purpose.
At Emmes Group, we’re shaping the future of clinical research—where human intelligence meets cutting-edge technology to drive meaningful advancements in healthcare. With over 47 years of scientific excellence, we’ve led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience.
Through our two business units—Emmes, a full-service CRO, and Veridix AI, our technology, data, and analytical solutions —we are modernizing clinical trials and accelerating the development of life-changing therapies.
We believe that every clinical breakthrough starts with people—people who are passionate, purpose-driven, and ready to make an impact. At Emmes Group, we bring People, Science, and Technology together to collaborate with our customers and deliver global health impact. Our culture is built on integrity, collaboration, and innovation, ensuring that every challenge is met with perseverance and accountability.
As part of Emmes' centralized Site and Patient Access group, the Study Startup Associate II provides administrative support to other team members on preparation of regulatory submission packages on international clinical trials. Gets involved in creation, filing, and updating of trackers and templates and assists in expedited startups and coordinates with other study team members on project specific communication. Liaise with cross functional teams as required.
Responsibilities:
- Creates MS project files to establish study start up timelines and processes for each country.
- Works with team members on preparation of regulatory submission packages.
- Tracks and follow up on missing documents.
- Prepares and submits applications to Regulatory Authorities, Central and Local IEC/IRB and other country specific application such as for Data Protection, Import License etc. as required.
- Helps prepare and coordinate activities related to ongoing submissions, amendments, and regular safety reporting and notification to IEC and regulatory authorities as required.
- Tracks the regulatory documents and assist in regulatory coordination, as instructed by other team members.
- Assists in review of the regulatory documents for completeness.
- Assists with translations coordination, e.g., for contracts across EU etc.
- Assists Senior Study Startup Associate and Study Startup Leads in coordinating with the sponsor to secure authorization of regulatory documents.
- Maintains up to date and accurate tracking on the status for each site in study trackers.
- Coordinates with study team members to collect and track essential documents for site activation.
- Interacts with other team members of Study Startup function on project specific status, communication, and deliverables.
- Works to the study timelines, documents/escalates study challenges, and communicates updates to the Lead as required.
- Maintains quality and regulatory compliance among investigational sites during Site Startup Provides updates to Lead/Manager on a regular basis and communicates any out of scope activities.
- Performs other duties as assigned.
- Complies with all policies and standards.
Qualifications
- Bachelor's Degree Healthcare related field Required or
- Master's Degree Healthcare related field Preferred
- 1-3 years working within pharma and/or CRO, preferably 1-2 years of experience in working on study start up activities. Equivalent combination of education, training and experience Required
- Knowledge of clinical research process related to study startup and medical terminology High
- Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members High
- Excellent organizational and interpersonal skills High
- Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities High
- Ability to manage multiple competing priorities within various clinical trials High
- Ability to work independently, prioritize and work with a matrix team environment is essential High
- Working knowledge of MS Project, Word and Excel is required High
If you’re looking for a career where your work advances global health and where scientific excellence meets real-world impact, join us and be part of something bigger. One Team, One Purpose.
CONNECT WITH US!
Find us on LinkedIn:/the-emmes-group/
Overview:
Study Start-Up Associate II
Be Part of One Team, One Purpose.
At Emmes Group, we’re shaping the future of clinical research—where human intelligence meets cutting-edge technology to drive meaningful advancements in healthcare. With over 47 years of scientific excellence, we’ve led groundbreaking research in cell and gene therapy, vaccines, infectious diseases, ophthalmology, rare diseases, and neuroscience.
Through our two business units—Emmes, a full-service CRO, and Veridix AI, our technology, data, and analytical solutions —we are modernizing clinical trials and accelerating the development of life-changing therapies.
We believe that every clinical breakthrough starts with people—people who are passionate, purpose-driven, and ready to make an impact. At Emmes Group, we bring People, Science, and Technology together to collaborate with our customers and deliver global health impact. Our culture is built on integrity, collaboration, and innovation, ensuring that every challenge is met with perseverance and accountability.
As part of Emmes' centralized Site and Patient Access group, the Study Startup Associate II provides administrative support to other team members on preparation of regulatory submission packages on international clinical trials. Gets involved in creation, filing, and updating of trackers and templates and assists in expedited startups and coordinates with other study team members on project specific communication. Liaise with cross functional teams as required.
Responsibilities:
- Creates MS project files to establish study start up timelines and processes for each country.
- Works with team members on preparation of regulatory submission packages.
- Tracks and follow up on missing documents.
- Prepares and submits applications to Regulatory Authorities, Central and Local IEC/IRB and other country specific application such as for Data Protection, Import License etc. as required.
- Helps prepare and coordinate activities related to ongoing submissions, amendments, and regular safety reporting and notification to IEC and regulatory authorities as required.
- Tracks the regulatory documents and assist in regulatory coordination, as instructed by other team members.
- Assists in review of the regulatory documents for completeness.
- Assists with translations coordination, e.g., for contracts across EU etc.
- Assists Senior Study Startup Associate and Study Startup Leads in coordinating with the sponsor to secure authorization of regulatory documents.
- Maintains up to date and accurate tracking on the status for each site in study trackers.
- Coordinates with study team members to collect and track essential documents for site activation.
- Interacts with other team members of Study Startup function on project specific status, communication, and deliverables.
- Works to the study timelines, documents/escalates study challenges, and communicates updates to the Lead as required.
- Maintains quality and regulatory compliance among investigational sites during Site Startup Provides updates to Lead/Manager on a regular basis and communicates any out of scope activities.
- Performs other duties as assigned.
- Complies with all policies and standards.
Qualifications
- Bachelor's Degree Healthcare related field Required or
- Master's Degree Healthcare related field Preferred
- 1-3 years working within pharma and/or CRO, preferably 1-2 years of experience in working on study start up activities. Equivalent combination of education, training and experience Required
- Knowledge of clinical research process related to study startup and medical terminology High
- Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members High
- Excellent organizational and interpersonal skills High
- Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities High
- Ability to manage multiple competing priorities within various clinical trials High
- Ability to work independently, prioritize and work with a matrix team environment is essential High
- Working knowledge of MS Project, Word and Excel is required High
If you’re looking for a career where your work advances global health and where scientific excellence meets real-world impact, join us and be part of something bigger. One Team, One Purpose.
CONNECT WITH US!
Find us on LinkedIn:/the-emmes-group/
See all OPT Study Start Up Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new OPT Study Start Up Jobs.
Get Access To All JobsTips for Finding OPT Sponsorship in Study Start Up
Confirm your degree aligns with the role
Study Start Up is a specialty occupation requiring a relevant degree. Clinical research, public health, nursing, or life sciences backgrounds align well. Verify your field maps directly to the job to support your OPT authorization and any future H-1B visa petition.
Target STEM OPT-eligible positions first
Many Study Start Up roles fall under CIP codes in biological sciences or health services administration, qualifying for 24-month STEM OPT extensions. Confirm the employer is E-Verify enrolled before accepting an offer, as that's required for STEM extension eligibility.
Prioritize contract research organizations and large sponsors
CROs like ICON, PPD, and Medpace, along with large pharmaceutical sponsors, have established immigration infrastructure. They're more experienced with OPT authorization, STEM extensions, and H-1B sponsorship, reducing the risk of authorization gaps during your employment.
Start your job search early relative to your OPT start date
Study Start Up hiring often involves background checks, training periods, and credentialing that extend onboarding timelines. Starting your search three to four months before your OPT begins gives you enough runway to clear these steps before your authorization window opens.
Ask directly about STEM extension and H-1B sponsorship history
During interviews, ask whether the company has sponsored STEM OPT extensions and H-1B visas for clinical research roles before. Employers with that track record have the legal processes in place, which significantly reduces risk for your long-term status.
Document your role's connection to your degree field
Keep a clear record of how your Study Start Up responsibilities tie to your degree. USCIS may request this during STEM extension or H-1B adjudication. Specific project descriptions and supervisor letters linking your work to your academic training are valuable evidence.
Study Start Up OPT: Frequently Asked Questions
Can I work in a Study Start Up role on F-1 OPT?
Yes. Study Start Up positions qualify as OPT-eligible employment as long as the role is directly related to your field of study. Degrees in clinical research, life sciences, public health, or healthcare administration typically support authorization. Your job offer and responsibilities should clearly connect to your degree to remain compliant with USCIS requirements.
Do Study Start Up jobs qualify for the STEM OPT extension?
Many do. If your degree falls under an eligible STEM CIP code, such as biological sciences or health services administration, and your employer is enrolled in E-Verify, you can apply for a 24-month STEM OPT extension. This gives you up to three years of total work authorization, making it easier to transition to H-1B sponsorship later.
Where can I find Study Start Up jobs that are open to OPT students?
Migrate Mate is the recommended platform for F-1 OPT students searching for Study Start Up roles. It filters jobs by sponsorship and OPT compatibility, so you can focus on employers who actively hire international students rather than spending time on applications at companies that don't.
What happens to my OPT status if my Study Start Up contract ends early?
You enter a 60-day grace period when your employment ends. During that window, you can find a new qualifying job, apply for a STEM extension if eligible, or change your immigration status. You cannot work during the grace period. Staying in close contact with your DSO throughout a job transition helps you avoid accidental status violations.
Will Study Start Up employers sponsor me for an H-1B after OPT?
Sponsorship varies by employer. Contract research organizations and large pharmaceutical companies are more likely to have existing H-1B processes for clinical research roles than smaller sponsors or academic sites. During interviews, ask specifically whether they have sponsored clinical operations or Study Start Up staff for H-1B visas before, and whether they work with an immigration attorney.