OPT Clinical Trial Manager Jobs
Clinical Trial Manager jobs are a strong fit for F-1 OPT students with degrees in life sciences, public health, or a related field. Most roles qualify as STEM OPT extensions, giving you up to three years of work authorization while you build sponsor relationships with contract research organizations and pharmaceutical companies.
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Get Access To All JobsINTRODUCTION
The Clinical Trial & Data Management Research Associate role in Emergency Medicine (EM) will be an integral member of the research team. This position will provide support for Emergency Medicine working alongside the ICTS team performing activities which are vitally important to grow and foster innovation through research support endeavors. This position will apply clinical skills to administer, deliver, and evaluate research protocols.
ROLE AND RESPONSIBILITIES
Research/Clinical Activities, Subject Recruitment and Enrollment
- Screen participant for study eligibility.
- Educate participant on scope of study, potential risks and benefits, possible alternatives, and study requirements for participant.
- Communicate with principal investigator and verify participant eligibility.
- Administer study treatments and identify adverse reactions.
- Recruit, enroll and obtain informed consent for clinical research activities. Oversee the recruitment of participants and scheduling of trial-related procedures.
- Prepare study recruitment materials. Develop complex study recruitment materials.
Protocol Development/Management and Study Responsibilities
- Collaborate with Principal Investigator and the study team in the development, execution, administration and maintenance of protocols and clinical studies and provide input into descriptions of complex research procedures.
- Assess participants for problems related to protocol. Oversee CRF development, database development and maintenance.
- Review query reports. Resolve all monitoring visit issues.
- Perform and monitor randomizations.
- Develop complex study materials used in conduction of study.
- Communicate with local health care practitioners, agencies, and sponsors as needed.
Data Collection and Monitoring
- Participate in the design, development, and testing of clinical research trial data systems.
- Maintain communication between health care clinical information systems and research data systems.
- Collect and validate data. Make recommendations for query resolution.
- Assist with identification of data problems and implement change as needed.
Regulatory Guidelines and Documents
- Manage and organize regulatory documentation.
- Prepare and submit regulatory documents.
- Assist sponsor with on-site audits of research and clinical data.
- Monitor and maintain compliance of regulatory guidelines and documents.
- Prepare and present Institutional Review Boards or other submissions and required regulatory documents.
- Carry out corrective action plan for reportable events.
Financial Responsibility
- Assist in the development and administer study budgets.
- Participate in preparation of grant applications for extramural funding.
- Oversee internal pilot funding program application process.
- Assist with tracking and reconciling grant budget free balances and identify opportunities to ensure that grant funding is being used as intended and awarded.
BASIC QUALIFICATIONS
Education Requirements:
A Bachelor’s degree in a Health Science field or an equivalent combination of education and research experience.
Experience Requirements:
- A minimum of one year experience designing, developing, and implementing recruitment program materials.
- Working knowledge of Good Clinical Practice (GCP) in research.
- Excellent written and verbal communication skills.
- Ability to work nights and weekends.
- Must be proficient in computer software applications (MS Word, Excel, PowerPoint, and Outlook).
PREFERRED QUALIFICATIONS
- Experience with REDCap, Epic and ACCESS.
- Previous experience in data collection and entry.
- Experience in processing research regulatory documents and ethics preparation.
- Excellent time management skills and ability to perform detail oriented work.
- 1-3 years of clinical research experience.
- Experience developing and working with research budgets/billing.
- A current, valid Registered Nurse license or Respiratory Therapist license.
- Database management experience including entering, tracking and maintaining data and troubleshooting.
APPLICATION PROCESS
In order to be considered, applications must upload a resume. Job openings are posted for a minimum of 7 calendar days. This job may be removed from posting and filled any time after the minimum posting period has ended. For questions or additional information, please contact Katie McVay at katie-mcvay@uiowa.edu. Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification. Up to 5 professional references will be requested at a later step in the recruitment process.
ADDITIONAL INFORMATION
- Classification Title: Clin Trials Rsrch Associate
- Appointment Type: Professional and Scientific
- Schedule: Full-time
- Work Modality Options: On Campus
COMPENSATION
- Pay Level: 4A
CONTACT INFORMATION
- Organization: Healthcare
- Contact Name: Katie McVay
- Contact Email: katie-mcvay@uiowa.edu
INTRODUCTION
The Clinical Trial & Data Management Research Associate role in Emergency Medicine (EM) will be an integral member of the research team. This position will provide support for Emergency Medicine working alongside the ICTS team performing activities which are vitally important to grow and foster innovation through research support endeavors. This position will apply clinical skills to administer, deliver, and evaluate research protocols.
ROLE AND RESPONSIBILITIES
Research/Clinical Activities, Subject Recruitment and Enrollment
- Screen participant for study eligibility.
- Educate participant on scope of study, potential risks and benefits, possible alternatives, and study requirements for participant.
- Communicate with principal investigator and verify participant eligibility.
- Administer study treatments and identify adverse reactions.
- Recruit, enroll and obtain informed consent for clinical research activities. Oversee the recruitment of participants and scheduling of trial-related procedures.
- Prepare study recruitment materials. Develop complex study recruitment materials.
Protocol Development/Management and Study Responsibilities
- Collaborate with Principal Investigator and the study team in the development, execution, administration and maintenance of protocols and clinical studies and provide input into descriptions of complex research procedures.
- Assess participants for problems related to protocol. Oversee CRF development, database development and maintenance.
- Review query reports. Resolve all monitoring visit issues.
- Perform and monitor randomizations.
- Develop complex study materials used in conduction of study.
- Communicate with local health care practitioners, agencies, and sponsors as needed.
Data Collection and Monitoring
- Participate in the design, development, and testing of clinical research trial data systems.
- Maintain communication between health care clinical information systems and research data systems.
- Collect and validate data. Make recommendations for query resolution.
- Assist with identification of data problems and implement change as needed.
Regulatory Guidelines and Documents
- Manage and organize regulatory documentation.
- Prepare and submit regulatory documents.
- Assist sponsor with on-site audits of research and clinical data.
- Monitor and maintain compliance of regulatory guidelines and documents.
- Prepare and present Institutional Review Boards or other submissions and required regulatory documents.
- Carry out corrective action plan for reportable events.
Financial Responsibility
- Assist in the development and administer study budgets.
- Participate in preparation of grant applications for extramural funding.
- Oversee internal pilot funding program application process.
- Assist with tracking and reconciling grant budget free balances and identify opportunities to ensure that grant funding is being used as intended and awarded.
BASIC QUALIFICATIONS
Education Requirements:
A Bachelor’s degree in a Health Science field or an equivalent combination of education and research experience.
Experience Requirements:
- A minimum of one year experience designing, developing, and implementing recruitment program materials.
- Working knowledge of Good Clinical Practice (GCP) in research.
- Excellent written and verbal communication skills.
- Ability to work nights and weekends.
- Must be proficient in computer software applications (MS Word, Excel, PowerPoint, and Outlook).
PREFERRED QUALIFICATIONS
- Experience with REDCap, Epic and ACCESS.
- Previous experience in data collection and entry.
- Experience in processing research regulatory documents and ethics preparation.
- Excellent time management skills and ability to perform detail oriented work.
- 1-3 years of clinical research experience.
- Experience developing and working with research budgets/billing.
- A current, valid Registered Nurse license or Respiratory Therapist license.
- Database management experience including entering, tracking and maintaining data and troubleshooting.
APPLICATION PROCESS
In order to be considered, applications must upload a resume. Job openings are posted for a minimum of 7 calendar days. This job may be removed from posting and filled any time after the minimum posting period has ended. For questions or additional information, please contact Katie McVay at katie-mcvay@uiowa.edu. Successful candidates will be required to self-disclose any conviction history and will be subject to a criminal background check and credential/education verification. Up to 5 professional references will be requested at a later step in the recruitment process.
ADDITIONAL INFORMATION
- Classification Title: Clin Trials Rsrch Associate
- Appointment Type: Professional and Scientific
- Schedule: Full-time
- Work Modality Options: On Campus
COMPENSATION
- Pay Level: 4A
CONTACT INFORMATION
- Organization: Healthcare
- Contact Name: Katie McVay
- Contact Email: katie-mcvay@uiowa.edu
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Get Access To All JobsTips for Finding OPT Sponsorship as a Clinical Trial Manager
Target CROs and pharmaceutical companies with established OPT pipelines
Contract research organizations like ICON, Syneos Health, and Parexel regularly hire international candidates. These employers already understand OPT timelines and reporting requirements, making them more likely to support your authorization without lengthy internal approvals.
Confirm your degree qualifies for STEM OPT extension
Clinical Trial Manager roles typically fall under CIP codes for biological sciences, public health, or biomedical engineering. Verify your specific degree program is on the STEM OPT designated list before accepting a role, since this determines your total work authorization window.
Address OPT timelines proactively in applications
Most clinical trial hiring cycles run 6 to 10 weeks. Apply early and mention your OPT end date in your initial outreach. Employers unfamiliar with STEM extension can plan ahead once they understand you have up to three years of continuous work authorization available.
Emphasize protocol and regulatory experience in your resume
Hiring managers for CTM roles screen heavily for ICH-GCP certification, protocol deviation management, and FDA or EMA regulatory familiarity. These credentials signal readiness for independent site management and make sponsorship conversations easier to initiate with risk-averse employers.
Negotiate sponsor commitment before your OPT expires
Start H-1B visa or O-1 visa sponsorship conversations at least 12 months before your OPT ends. Clinical trial employers who value continuity on long-running studies are often willing to sponsor rather than lose a manager mid-trial, especially after protocol training investment.
Leverage your university's DSO resources for employer education
Some hiring managers confuse OPT with CPT or assume sponsorship is required immediately. Your DSO can provide employer fact sheets explaining that OPT requires no petition or employer cost, removing a common objection before salary negotiations even begin.
Clinical Trial Manager OPT: Frequently Asked Questions
Do Clinical Trial Manager jobs qualify for the STEM OPT extension?
Most Clinical Trial Manager positions qualify for the 24-month STEM OPT extension if your degree is in a qualifying field such as biological sciences, public health, biomedical engineering, or a related discipline listed on the STEM OPT designated program list. You should confirm your specific CIP code with your DSO before accepting an offer, since the job title alone does not determine eligibility.
What should I know about the 90-day unemployment limit while job searching?
F-1 OPT students are limited to 90 cumulative days of unemployment during the standard OPT period. If you receive the STEM extension, you get an additional 60 days, for 150 days total across the full OPT period. Clinical trial hiring cycles can run 6 to 10 weeks, so apply as early as possible after graduation and track your unemployment days carefully to avoid status violations.
Can I work as a Clinical Trial Manager on a freelance or contract basis during OPT?
Yes, OPT permits self-employment and independent contracting, but the work must be directly related to your degree field and average at least 20 hours per week. If you take contract assignments through a CRO or staffing agency, ensure the arrangement is documented and that your role genuinely aligns with your degree program, as DSOs may review this during reporting.
Where can I find Clinical Trial Manager jobs that are open to OPT candidates?
Migrate Mate is built specifically for F-1 OPT and international students, so every listing on the platform is filterable by visa sponsorship and OPT-friendly status. Searching there saves time compared to manually screening generic job postings that rarely disclose work authorization requirements upfront.
What reporting requirements apply to OPT students working as Clinical Trial Managers?
You must report any change in employer, job title, work address, or employment status to your DSO within 10 days, and your DSO updates SEVIS accordingly. For STEM OPT extension holders, your employer must also submit a formal training plan using Form I-983 and conduct self-evaluations at the six-month and annual marks. Failing to report changes on time can jeopardize your status even if the underlying employment is valid.