STEM OPT Clinical Research Jobs
Clinical Research roles in biostatistics, pharmacovigilance, data management, and regulatory affairs qualify for STEM OPT because they map to STEM CIP codes in biological sciences, computer science, and statistics. Your employer must be enrolled in E-Verify, and your 24-month extension gives you three full years of post-graduation authorization to build a research career in the U.S.
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Get Access To All JobsPURPOSE AND SCOPE:
Works under the supervision of the Principal Investigator (PI), Director and other site personnel as applicable. Conceptually applies the research protocol to the clinical setting to allow accurate and timely completion of all duties. Maintains appropriate documentation associated with the assigned clinical study. Ensures studies are conducted according to established company policies and procedures as well as all applicable State and Federal regulations, specifically Good Clinical Practice (GCP), ICH, and FDA guidelines.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Develops in-depth understanding of each study protocol to ensure all aspects of the protocol are adhered to in accordance with FDA, GCP, and ICH Guidelines.
- Under the supervision of the Principal Investigator (PI) and appropriate management prepares and submits regulatory documents in an accurate and timely manner.
- In collaboration with the PI, incorporates clinical judgment and knowledge of protocol to identify potential study participants according to inclusion and exclusion criteria.
- Obtains informed consent according to GCP.
- Schedules subject visits.
- Prepares labs/tests per protocol.
- Responsible for study drug storage and drug accountability according to the parameters of the study protocol and sponsor requirements.
- Administers the investigational product according to the parameters of the study protocol and under the direction of the physician. LVNs/LPNs may administer medications under their state licensure and under the order of the PI. Non-LVNs may administer oral and subcutaneous drugs with appropriate training and under the license of the PI.
- Monitors and evaluates patients’ condition with regard to the investigational product.
- Consults with PI regarding the appropriate administration of investigational product.
- Conducts routine assessments to evaluate the subject’s response to investigational product, and communicates observations to the PI, sponsor and IRB as appropriate.
- Educates the subject about the applicable study particulars.
- Informs/updates the subject about pertinent study details as needed.
- Documents subject information as it pertains to the clinical study according to the principals of ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate).
- Meets with the study monitor to review, verify and correct all data entered onto the case report form and to ensure appropriate maintenance of study records.
- Reviews all lab/tests with the physician in a timely manner.
- Reports subject’s progress, complaints and issues to PI, study sponsor, or IRB as needed in a timely manner.
- Conducts ongoing assessments of the overall study execution within the facility/practice, communicating concerns to the Director, PI, study sponsor or IRB as needed.
- Notifies appropriate management and external parties of serious adverse events according to protocol.
- Collects pre-study essential documents as needed according to GCP and files appropriately in the study record.
- Maintains the study file record according to GCP.
- Maintains subject participant records according to GCP.
- Provides a list of all study participants to facility/practice management to avoid improper billing of lab tests or services covered under the research budget.
- Ensures appropriate storage, access, and maintenance of records pertaining to investigational product.
- Documents investigational product received, dispensed, and returned to study sponsor according to GCP.
- Completes the clinical trials management system and electronic/paper case report forms in an accurate and timely manner.
- Attends Investigator Meetings as necessary.
- Other duties as assigned.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
- The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Day to day work includes desk and personal computer work and interaction with patients, facility staff and physicians.
- The work environment is characteristic of a health care facility with air temperature control and moderate noise levels. May be exposed to infectious and contagious diseases/materials.
- The position requires 10 – 15% travel between assigned facilities and various locations within the community. Travel to regional, Business Unit and Corporate meetings may be required.
SUPERVISION:
- None
Education:
- Bachelor’s Degree or an equivalent combination of education and experience
- Graduate of a technical program in healthcare (e.g. LVN/LPN, Medical Assistant or Dialysis Technician) AA in Life Sciences or other health related field. Advanced Degree preferred.
EXPERIENCE AND REQUIRED SKILLS:
- 2 to 5 years’ healthcare experience with Dialysis experience preferred.
- Research experience preferred.
- Willing to pursue CCRC or SoCRA certification when eligible.
- Current appropriate state licensure if applicable.
- Proficient with PCs and Microsoft Office applications.
- Good communication and organizational skills.
- Ability to work independently.
Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws.
EOE, disability/veterans
PURPOSE AND SCOPE:
Works under the supervision of the Principal Investigator (PI), Director and other site personnel as applicable. Conceptually applies the research protocol to the clinical setting to allow accurate and timely completion of all duties. Maintains appropriate documentation associated with the assigned clinical study. Ensures studies are conducted according to established company policies and procedures as well as all applicable State and Federal regulations, specifically Good Clinical Practice (GCP), ICH, and FDA guidelines.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
- Develops in-depth understanding of each study protocol to ensure all aspects of the protocol are adhered to in accordance with FDA, GCP, and ICH Guidelines.
- Under the supervision of the Principal Investigator (PI) and appropriate management prepares and submits regulatory documents in an accurate and timely manner.
- In collaboration with the PI, incorporates clinical judgment and knowledge of protocol to identify potential study participants according to inclusion and exclusion criteria.
- Obtains informed consent according to GCP.
- Schedules subject visits.
- Prepares labs/tests per protocol.
- Responsible for study drug storage and drug accountability according to the parameters of the study protocol and sponsor requirements.
- Administers the investigational product according to the parameters of the study protocol and under the direction of the physician. LVNs/LPNs may administer medications under their state licensure and under the order of the PI. Non-LVNs may administer oral and subcutaneous drugs with appropriate training and under the license of the PI.
- Monitors and evaluates patients’ condition with regard to the investigational product.
- Consults with PI regarding the appropriate administration of investigational product.
- Conducts routine assessments to evaluate the subject’s response to investigational product, and communicates observations to the PI, sponsor and IRB as appropriate.
- Educates the subject about the applicable study particulars.
- Informs/updates the subject about pertinent study details as needed.
- Documents subject information as it pertains to the clinical study according to the principals of ALCOA (Attributable, Legible, Contemporaneous, Original, Accurate).
- Meets with the study monitor to review, verify and correct all data entered onto the case report form and to ensure appropriate maintenance of study records.
- Reviews all lab/tests with the physician in a timely manner.
- Reports subject’s progress, complaints and issues to PI, study sponsor, or IRB as needed in a timely manner.
- Conducts ongoing assessments of the overall study execution within the facility/practice, communicating concerns to the Director, PI, study sponsor or IRB as needed.
- Notifies appropriate management and external parties of serious adverse events according to protocol.
- Collects pre-study essential documents as needed according to GCP and files appropriately in the study record.
- Maintains the study file record according to GCP.
- Maintains subject participant records according to GCP.
- Provides a list of all study participants to facility/practice management to avoid improper billing of lab tests or services covered under the research budget.
- Ensures appropriate storage, access, and maintenance of records pertaining to investigational product.
- Documents investigational product received, dispensed, and returned to study sponsor according to GCP.
- Completes the clinical trials management system and electronic/paper case report forms in an accurate and timely manner.
- Attends Investigator Meetings as necessary.
- Other duties as assigned.
PHYSICAL DEMANDS AND WORKING CONDITIONS:
- The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
- Day to day work includes desk and personal computer work and interaction with patients, facility staff and physicians.
- The work environment is characteristic of a health care facility with air temperature control and moderate noise levels. May be exposed to infectious and contagious diseases/materials.
- The position requires 10 – 15% travel between assigned facilities and various locations within the community. Travel to regional, Business Unit and Corporate meetings may be required.
SUPERVISION:
- None
Education:
- Bachelor’s Degree or an equivalent combination of education and experience
- Graduate of a technical program in healthcare (e.g. LVN/LPN, Medical Assistant or Dialysis Technician) AA in Life Sciences or other health related field. Advanced Degree preferred.
EXPERIENCE AND REQUIRED SKILLS:
- 2 to 5 years’ healthcare experience with Dialysis experience preferred.
- Research experience preferred.
- Willing to pursue CCRC or SoCRA certification when eligible.
- Current appropriate state licensure if applicable.
- Proficient with PCs and Microsoft Office applications.
- Good communication and organizational skills.
- Ability to work independently.
Fresenius Medical Care maintains a drug-free workplace in accordance with applicable federal and state laws.
EOE, disability/veterans
See all 751+ STEM OPT Clinical Research Jobs
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Get Access To All JobsTips for Finding STEM OPT Authorization in Clinical Research
Verify your CIP code matches clinical research
Check your degree's Classification of Instructional Programs code against the DHS STEM Designated Degree Program List. Degrees in biological sciences, biostatistics, public health sciences, and computer science commonly support clinical research roles. Your DSO confirms the match before you apply.
Confirm E-Verify enrollment before accepting offers
Every employer hiring you on STEM OPT must be enrolled in E-Verify. Ask recruiters directly or search the E-Verify employer search tool during your job hunt, not after you receive an offer. Sites, CROs, and sponsors each count as separate employers and must enroll independently.
Target clinical research organizations and sponsors actively filing LCAs
Pharmaceutical companies, contract research organizations, and academic medical centers regularly file Labor Condition Applications for clinical roles. Use the OFLC Wage Search to identify which organizations have recent LCA activity for research coordinator, biostatistician, and regulatory affairs titles in your target location.
Use Migrate Mate to find employers already sponsoring STEM OPT roles
Filter your clinical research job search on Migrate Mate to surface employers with verified E-Verify enrollment and active LCA filing history. This removes the guesswork of cold-applying to organizations that have never sponsored international students in research roles.
Build your I-983 training plan around concrete research deliverables
USCIS requires your I-983 to describe how the job provides practical training in your STEM field. For clinical research, list specific competencies: protocol design, data integrity monitoring, adverse event reporting, or statistical analysis. Vague descriptions of 'general research duties' draw DSO scrutiny and delay approval.
Time your H-1B cap-gap transition around clinical trial cycles
If your employer files an H-1B visa petition before your OPT expires, cap-gap extends your authorization through September 30. Clinical trials often run on multi-year timelines, so coordinate your transition with your study team to avoid gaps during critical data collection or closeout phases.
Frequently Asked Questions
Which STEM degrees qualify for the OPT extension in clinical research roles?
Degrees on the DHS STEM Designated Degree Program List that commonly support clinical research positions include biological sciences, biostatistics, public health sciences, computer science, and health informatics. Your specific CIP code must appear on the list, and your DSO verifies the match before authorizing the extension. Check your transcript for the exact program name and confirm with your international student office.
Does every site or organization involved in my clinical trial need to be enrolled in E-Verify?
Your direct employer of record must be enrolled in E-Verify. If you are hired by a contract research organization and assigned to a sponsor site, it is the CRO's E-Verify enrollment that matters, not the sponsor's. If you move to a new employer, including a different CRO or a hospital system, that organization must independently be enrolled in E-Verify before your STEM OPT authorization applies to that position.
What should my I-983 training plan include for a clinical research role?
Your I-983 must connect your daily job duties to your STEM field of study. For clinical research, that means documenting specific skills like protocol adherence, adverse event coding, biostatistical analysis, regulatory submission preparation, or clinical data management. Generic language about supporting a research team is not sufficient. Your employer's supervisor signs the form and takes responsibility for the training relationship, so both parties should review it carefully before submission.
How does cap-gap protection work if my employer files an H-1B petition during my clinical research position?
If your employer files a timely H-1B cap-subject petition before your OPT EAD expires, cap-gap automatically extends your work authorization through September 30 of that year. If USCIS selects and approves your petition, your status changes to H-1B on October 1. During the cap-gap period you can continue working in your clinical research role without interruption. USCIS publishes cap-gap guidance that explains which receipt notices serve as proof of continued authorization.
Where can I find clinical research employers that sponsor STEM OPT students?
Migrate Mate filters clinical research jobs by employers with active E-Verify enrollment and LCA filing history, so you can identify organizations that have already hired international students in research roles. You can also cross-reference employer names against the OFLC Wage Search to see which companies have filed Labor Condition Applications for clinical coordinator, biostatistician, or regulatory affairs positions in your target city.