OPT Clinical Research Manager Jobs
Clinical Research Manager jobs on OPT require employers who understand FDA-regulated trial environments and are willing to sponsor work authorization. Most roles fall under STEM OPT, giving you up to 36 months of work authorization, and demand a background in life sciences, public health, or a related clinical field.
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Get Access To All JobsINTRODUCTION
Stanford University is seeking a Clinical Research Manager to provide leadership and oversight of one large or multiple small clinical research projects. Supervise multiple clinical research staff. Manage clinical research operations, including quality management, personnel management, regulatory compliance, and fiscal oversight.
DUTIES INCLUDE:
- Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials. Monitor staffing levels and identify adequate coverage for trial workload across teams of study coordinators.
- Supervise the implementation of and adherence to study protocols. Educate research staff on established policies, processes, and procedures.
- Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Develop consent forms for approval by Human Subjects Panel.
- Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug applications to the FDA as required.
- Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to requests and questions.
- Provide leadership and expertise in identifying and completing research grants. Oversee financial resources, as needed, create internal and external budgets for research protocols, assure financial accountability, and serve as primary liaison between sponsor, department accounting, and Research Management Group.
- Lead or chair committees or task forces to address and resolve significant issues.
- Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences.
- Analyze trends in recruitment and assure there is a limited number of competing trials. Make recommendations for a variety of options within a trial; track physician compliance.
-
Assist with analysis of data and preparation of manuscripts and scientific presentations.
-
Other duties may also be assigned.
DESIRED QUALIFICATIONS:
- Direct intervention and/or testing experience with children and families with autism and other neurodevelopmental disorders.
- Proficiency in developing and utilizing databases within RedCap.
- Proficiency in use of electronic medical record systems.
- Experience collaborating in multidisciplinary, patient-centered clinical care, research, and community-based team settings.
- Training in administration and scoring of developmental, cognitive, and autism diagnostic measures.
- Experience in large-scale event planning and management of professional training program logistics, including financial tracking and on-site execution, within academic and healthcare settings.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree in related field and five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master's degree preferred.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Excellent interpersonal skills.
- Proficiency in Microsoft Office and database applications.
- Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
- Knowledge of medical terminology.
- Demonstrated managerial experience.
CERTIFICATIONS & LICENSES:
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
Physical Requirements:
- Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
- Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
-
Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.
-
Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.
WORKING CONDITIONS:
- Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.
- May require extended or unusual work hours based on research requirements and business needs.
COMPENSATION
- The expected pay range for this position is $124,521 – $153,615 per annum.
Stanford University provides pay ranges representing its good faith estimate of the salary the university reasonably expects to pay for a position upon hire. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location, and external market pay for comparable jobs.
At Stanford University, base pay represents only one aspect of the comprehensive rewards package.
The Cardinal at Work website provides detailed information on Stanford’s extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.
- Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.
INTRODUCTION
Stanford University is seeking a Clinical Research Manager to provide leadership and oversight of one large or multiple small clinical research projects. Supervise multiple clinical research staff. Manage clinical research operations, including quality management, personnel management, regulatory compliance, and fiscal oversight.
DUTIES INCLUDE:
- Hire, orient, train, and conduct performance reviews for staff handling research administration activities associated with the conducting of clinical trials. Monitor staffing levels and identify adequate coverage for trial workload across teams of study coordinators.
- Supervise the implementation of and adherence to study protocols. Educate research staff on established policies, processes, and procedures.
- Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials. Develop consent forms for approval by Human Subjects Panel.
- Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies. Complete annual reports to Institutional Review Board, CSTA, FDA and other regulatory agencies. Submit Investigational New Drug applications to the FDA as required.
- Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, and respond to requests and questions.
- Provide leadership and expertise in identifying and completing research grants. Oversee financial resources, as needed, create internal and external budgets for research protocols, assure financial accountability, and serve as primary liaison between sponsor, department accounting, and Research Management Group.
- Lead or chair committees or task forces to address and resolve significant issues.
- Engage in high-level outreach and networking opportunities, representing the research program to a variety of internal and external audiences.
- Analyze trends in recruitment and assure there is a limited number of competing trials. Make recommendations for a variety of options within a trial; track physician compliance.
-
Assist with analysis of data and preparation of manuscripts and scientific presentations.
-
Other duties may also be assigned.
DESIRED QUALIFICATIONS:
- Direct intervention and/or testing experience with children and families with autism and other neurodevelopmental disorders.
- Proficiency in developing and utilizing databases within RedCap.
- Proficiency in use of electronic medical record systems.
- Experience collaborating in multidisciplinary, patient-centered clinical care, research, and community-based team settings.
- Training in administration and scoring of developmental, cognitive, and autism diagnostic measures.
- Experience in large-scale event planning and management of professional training program logistics, including financial tracking and on-site execution, within academic and healthcare settings.
EDUCATION & EXPERIENCE (REQUIRED):
Bachelor's degree in related field and five years of experience in clinical research, or an equivalent combination of education and relevant experience. Master's degree preferred.
KNOWLEDGE, SKILLS AND ABILITIES (REQUIRED):
- Excellent interpersonal skills.
- Proficiency in Microsoft Office and database applications.
- Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices.
- Knowledge of medical terminology.
- Demonstrated managerial experience.
CERTIFICATIONS & LICENSES:
Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred.
Physical Requirements:
- Frequently stand, walk, twist, bend, stoop, squat and use fine light/fine grasping.
- Occasionally sit, reach above shoulders, perform desk based computer tasks, use a telephone and write by hand, lift, carry, push, and pull objects that weigh up to 40 pounds.
-
Rarely kneel, crawl, climb ladders, grasp forcefully, sort and file paperwork or parts, rarely lift, carry, push, and pull objects that weigh 40 pounds or more.
-
Consistent with its obligations under the law, the University will provide reasonable accommodation to any employee with a disability who requires accommodation to perform the essential functions of his or her job.
WORKING CONDITIONS:
- Position may at times require the employee to work with or be in areas where hazardous materials and/or exposure to chemicals, blood, body fluid or tissues and risk of exposure to contagious diseases and infections.
- May require extended or unusual work hours based on research requirements and business needs.
COMPENSATION
- The expected pay range for this position is $124,521 – $153,615 per annum.
Stanford University provides pay ranges representing its good faith estimate of the salary the university reasonably expects to pay for a position upon hire. The pay offered to a selected candidate will be determined based on factors such as (but not limited to) the scope and responsibilities of the position, the qualifications of the selected candidate, departmental budget availability, internal equity, geographic location, and external market pay for comparable jobs.
At Stanford University, base pay represents only one aspect of the comprehensive rewards package.
The Cardinal at Work website provides detailed information on Stanford’s extensive range of benefits and rewards offered to employees. Specifics about the rewards package for this position may be discussed during the hiring process.
- Stanford is an equal employment opportunity and affirmative action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law.
See all 160+ OPT Clinical Research Manager Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new OPT Clinical Research Manager Jobs.
Get Access To All JobsTips for Finding OPT Sponsorship as a Clinical Research Manager
Target STEM-designated programs
A STEM OPT extension gives you 36 months of total work authorization instead of 12. Clinical Research Manager roles typically qualify when your degree is in biology, public health, or a related life sciences field. Confirm your CIP code with your DSO early.
Focus on large CROs and pharma companies
Contract research organizations like large pharma sponsors run structured hiring programs and are familiar with OPT paperwork. Smaller startups may not have sponsored international hires before, making the process slower and less predictable for time-sensitive OPT situations.
Highlight ICH GCP and regulatory experience upfront
Clinical Research Managers with documented ICH GCP certification and FDA or IRB regulatory experience are harder to replace locally. Framing your specialization around compliance knowledge makes sponsorship feel like a straightforward business decision rather than an immigration favor.
Apply before your OPT end date, not after
H-1B visa cap-subject petitions must be filed for October 1 starts. If your OPT expires mid-year, time your job search to allow for petition prep. Beginning your search at least six months before expiration gives employers enough runway to act.
Address the E-Verify requirement in your application
OPT employers must be enrolled in E-Verify. Before investing time in an application, confirm the employer participates. Most large healthcare and pharma companies already do, but smaller sites and academic medical centers sometimes do not.
Quantify your trial management outcomes
Employers weighing OPT sponsorship costs want clear evidence of value. Quantify your impact by citing enrollment rates you improved, protocol deviations you reduced, or sites you managed simultaneously. Concrete metrics lower perceived sponsorship risk considerably.
Clinical Research Manager OPT: Frequently Asked Questions
Do Clinical Research Manager jobs typically qualify for STEM OPT extension?
Most Clinical Research Manager roles qualify for the 24-month STEM OPT extension when your degree is in a STEM-designated field such as biology, biochemistry, public health, or biomedical sciences. The extension is tied to your degree's CIP code, not the job title itself, so confirm eligibility with your DSO before assuming you qualify.
How do I find Clinical Research Manager jobs that are open to OPT candidates?
Migrate Mate is the most direct way to find Clinical Research Manager roles where employers are open to OPT work authorization. Standard job boards don't filter by sponsorship willingness, which means you can spend weeks applying to roles that won't move forward once your visa status comes up. Searching on Migrate Mate removes that friction.
Can I work as a Clinical Research Manager at an academic medical center on OPT?
Yes, academic medical centers can hire OPT students, but you must confirm they are enrolled in E-Verify before accepting an offer. Academic institutions sometimes have slower HR processes around international hiring, so ask your potential employer directly and early. Some cap-exempt institutions can also sponsor H-1B visas outside the annual lottery.
What happens to my OPT status if my clinical research contract ends between trials?
OPT allows up to 90 days of unemployment in total, and for STEM OPT holders, that drops to 150 days across the full extension period. If your contract-based role ends between studies, that gap counts against your unemployment limit. Having a transition timeline from your employer documented in writing protects you if USCIS ever reviews your authorization period.
Is a Clinical Research Manager role considered a specialty occupation for H-1B purposes?
Clinical Research Manager positions generally qualify as specialty occupations for H-1B because they require at minimum a bachelor's degree in a specific scientific or clinical field. However, approval depends on how the employer writes the job description. Roles that mention a broad range of acceptable degrees or do not require a degree in a specific discipline can face USCIS scrutiny during adjudication.