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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Get Access To All JobsINTRODUCTION
Study Start-Up Associate II US Remote
Emmes Group: Building a better future for us all.
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.
We believe the work we do will have a direct impact on patients’ lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We’re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!
PRIMARY PURPOSE
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.
QUALIFICATIONS
- Bachelor degree Life Sciences, Health Sciences, Nursing, or a related field required.
- Master's Degree MS, MPH, PharmD (Preferred)
- 1 to 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.
- Knowledge of clinical research process related to study startup and medical terminology.
- Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members.
- Excellent organizational and interpersonal skills.
- Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
- Ability to manage multiple competing priorities within various clinical trials.
- Ability to work independently, prioritize and work with a matrix team environment is essential.
- Working knowledge of MS Project, Word and Excel is required.
WHY WORK AT EMMES?
At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:
- Flexible Approved Time Off
- Tuition Reimbursement
- 401k Retirement Plan
- Work From Home Anywhere in the US
- Maternal/Paternal Leave
- Casual Dress Code & Work Environment
CONNECT WITH US!
Follow us on Twitter - @EmmesCRO
Find us on LinkedIn - Emmes
The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.
LI-Remote
INTRODUCTION
Study Start-Up Associate II US Remote
Emmes Group: Building a better future for us all.
Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.
We believe the work we do will have a direct impact on patients’ lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We’re looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us!
PRIMARY PURPOSE
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.
QUALIFICATIONS
- Bachelor degree Life Sciences, Health Sciences, Nursing, or a related field required.
- Master's Degree MS, MPH, PharmD (Preferred)
- 1 to 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.
- Knowledge of clinical research process related to study startup and medical terminology.
- Strong written and verbal communication skills to express complex ideas to study personnel, internal and sponsor team members.
- Excellent organizational and interpersonal skills.
- Positive attitude and ability to interact with all levels of staff to coordinate and execute study activities.
- Ability to manage multiple competing priorities within various clinical trials.
- Ability to work independently, prioritize and work with a matrix team environment is essential.
- Working knowledge of MS Project, Word and Excel is required.
WHY WORK AT EMMES?
At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:
- Flexible Approved Time Off
- Tuition Reimbursement
- 401k Retirement Plan
- Work From Home Anywhere in the US
- Maternal/Paternal Leave
- Casual Dress Code & Work Environment
CONNECT WITH US!
Follow us on Twitter - @EmmesCRO
Find us on LinkedIn - Emmes
The Emmes Company, LLC is an equal opportunity employer and does not discriminate in its selection and employment practices. All qualified applicants will receive consideration for employment without regard to disability or protected veteran status.
LI-Remote
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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.