E-3 Visa Clinical Research Director Jobs
Clinical Research Director roles in the U.S. require a bachelor's degree in a life sciences or related field, and most positions at sponsor-active CROs, pharma companies, and academic medical centers qualify as E-3 specialty occupations. Australian nationals can secure E-3 visa sponsorship without entering a lottery, making this one of the most direct paths to leading U.S. clinical trials.
Find E-3 Visa Clinical Research Director JobsOverview
Showing 5 of 743+ Clinical Research Director jobs
See all 743+ Clinical Research Director Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Clinical Research Director roles.
Get Access To All JobsAs a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.
Job Location (Full Address):
275 Hutchison Rd, Rochester, New York, United States of America, 14627
Opening:
Worker Subtype:
Regular
Time Type:
Full time
Scheduled Weekly Hours:
40
Department:
400295 Cancer Center Admin M&D
Work Shift:
UR - Day (United States of America)
Range:
UR URG 114
Compensation Range:
$86,900.00 - $130,300.00
The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.
Responsibilities:
The Executive Director, Clinical Research Operations (ED) serves as a key enterprise leader responsible for the strategic direction, operational execution, and continuous advancement of clinical research across Wilmot Cancer Institute’s Clinical Research Enterprise. In collaboration with the Associate Director for Clinical Research, Associate Director for Administration, and the Clinical Trials Office (CTO) Medical Director, the incumbent will ensure the development of WCI’s clinical research infrastructure is consistent with expectations of NCI-designated Cancer Centers as outlined in the Cancer Center Support Grant (CCSG) guidelines.
Reporting to senior executive leadership, the ED ensures the delivery of a high-performing, standardized, and patient-centered clinical trials infrastructure that enables equitable access to innovative therapies across all sites of care. This leader is accountable for optimizing trial activation, enrollment, execution, and closeout while maintaining the highest standards of quality, regulatory compliance, and patient safety. The ED partners closely with physician leaders, principal investigators, sponsors, and administrative stakeholders to expand research capabilities, accelerate accrual, and enhance the overall patient and provider experience.
ESSENTIAL FUNCTIONS
Enterprise Strategy & Operational Leadership
- Define and execute a comprehensive, systemwide strategy for clinical trial operations that aligns with Wilmot’s strategic priorities and NCI designation requirements.
- As the primary operational leader, lead the design, standardization, and scaling of workflows, infrastructure, and technologies to support efficient and high-quality trial delivery.
- Drive integration of clinical research into care delivery models to ensure trials are accessible, scalable, and embedded across all regions.
- Establish governance structures, performance dashboards, and reporting mechanisms to ensure transparency, accountability, and continuous improvement.
- Represent clinical trial operations in executive forums and contribute to enterprise-wide strategic planning initiatives.
- Translate scientific and programmatic priorities set by the cancer center director and associate director for clinical research into actionable operational strategies.
- Anticipate and respond to shifts in the clinical trials landscape (e.g. NCTN, NCORP, ETCTN, industry-sponsored, IIT) to keep the portfolio competitive and diversified.
Stakeholder Engagement & Collaboration
- Build and sustain strong partnerships with disease program leadership, principal investigators, clinical and operational leaders, foundation leadership, and industry sponsors.
- Serve as a key liaison between research, clinical operations, finance, and administrative functions to ensure alignment and shared accountability.
- Strengthen external relationships with sponsors and partners to enhance study opportunities, improve activation timelines, and expand the research portfolio.
- Partner closely with the associate director for clinical research on scientific prioritization, protocol portfolio balance, and trial accrual strategy.
- Collaborate with the associate director for administration on applicable budget alignment, space planning, and institutional resource allocation.
Clinical Research Execution & Quality Oversight
- Establish and enforce systemwide standards for study start-up, conduct, monitoring, and closeout, ensuring compliance with all regulatory and accreditation requirements with FDA, ICH-GCP, NCI. OHRP, and institutional regulatory office.
- Oversee the development and implementation of standard operating procedures (SOPs), quality assurance programs, and audit readiness processes.
- Ensure consistent delivery of safe, ethical, and high-quality research, with a strong focus on patient experience and outcomes.
- Identify operational bottlenecks and implement scalable solutions to improve trial activation speed, enrollment, and data integrity.
- Serve as a liaison between the CTO and supporting institutional entities, including IRB, PRMC, Pharmacy, Tissue bank, Pathology, Radiology, and DSMC.
- Oversee clinical trial agreement negotiation, budget development, and coverage analysis in coordination with Sponsored Programs and Administration.
- Maintain oversight of clinical research information systems (CTMS, OnCore, EDC platforms etc. to ensure accurate, real-time portfolio tracking.
People & Talent Leadership
- Provide executive oversight of clinical research personnel across the system, including workforce planning, recruitment, retention, and succession planning.
- Foster a culture of accountability, collaboration, and continuous learning among research staff and leadership.
- Develop and implement comprehensive onboarding, training, and professional development programs to ensure staff are highly skilled and compliant with evolving regulations.
- Coach and mentor leaders to build a strong, sustainable pipeline of talent.
- Establish career ladders, competency frameworks and professional development pathways to strengthen workforce capability and retention.
Financial Stewardship & Growth
- Oversee the financial performance of clinical trial operations, including budgeting, forecasting, and resource allocation and report financial performance and portfolio growth metrics to cancer center leadership and relevant oversight committees.
- Identify opportunities to improve operational efficiency, optimize cost structures, and enhance revenue generation through research activities.
- Collaborate with finance and business development teams to evaluate and launch new programs, services, and partnerships that support research growth.
- Monitor per-patient trial costs and negotiate sponsor budgets to ensure financial sustainability of trial conduct.
Performance Improvement, Analytics & Innovation
- Define key performance indicators (KPIs) and leverage data analytics to monitor performance, identify trends, and inform decision-making.
- Lead systemwide quality and performance improvement initiatives aimed at increasing trial access, enrollment, and operational efficiency.
- Champion innovation in clinical trial delivery, including decentralized trials, digital tools, and novel care models.
- Ensure alignment of trial portfolios with patient population needs, organizational capabilities, and strategic priorities.
- Benchmarks performance against peer NCI-designated cancer centers and national best practices.
Clinical Research Care Coordination & Access
- Promote a coordinated, patient-centered approach to clinical research across all sites, ensuring seamless integration with clinical care pathways.
- Align trial availability with disease prevalence, community needs, and site capabilities to improve equitable access to research in collaboration with marketing/communication to raise awareness of trial availability among patients, providers, and the community.
- Partners with clinical and administrative leaders to remove barriers to participation and enhance patient engagement in trials.
MINIMUM EDUCATION & EXPERIENCE
- Master's degree and 5 years of relevant experience (or Ph D) required
- Or equivalent combination of education and experience
- 2 years in a managerial capacity required
KNOWLEDGE, SKILLS AND ABILITIES (preferred)
- 10+ years of clinical trial experience with 5+ years of managerial level with significant experience in an academic medical center or NCI-designated cancer center setting.
- Evidence of progressive leadership experience
- Knowledge and/or experience with NCI CCSG expectations
- Direct experience with clinical trial management systems such as OnCore, Velos, Clinical Conductor, etc.
- Previous experience coordinating and managing oncology clinical research programs
- Extensive knowledge in clinical research operations and associated regulations governing clinical research
- Strong interpersonal and relationship-building skills to engage physicians, scientists, administrators, and external sponsors
- Strong financial acumen, including budget development, forecasting, and cost/revenue management
- Exceptional strategic thinking and ability to translate institutional priorities into operational execution
- Strong communication skills (verbal and written)
- Ability to provide leadership and promote collaboration
- Possess exceptional time management skills
- Excellent interpersonal skills
The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University’s Mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.
As a community, the University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive.
Job Location (Full Address):
275 Hutchison Rd, Rochester, New York, United States of America, 14627
Opening:
Worker Subtype:
Regular
Time Type:
Full time
Scheduled Weekly Hours:
40
Department:
400295 Cancer Center Admin M&D
Work Shift:
UR - Day (United States of America)
Range:
UR URG 114
Compensation Range:
$86,900.00 - $130,300.00
The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.
Responsibilities:
The Executive Director, Clinical Research Operations (ED) serves as a key enterprise leader responsible for the strategic direction, operational execution, and continuous advancement of clinical research across Wilmot Cancer Institute’s Clinical Research Enterprise. In collaboration with the Associate Director for Clinical Research, Associate Director for Administration, and the Clinical Trials Office (CTO) Medical Director, the incumbent will ensure the development of WCI’s clinical research infrastructure is consistent with expectations of NCI-designated Cancer Centers as outlined in the Cancer Center Support Grant (CCSG) guidelines.
Reporting to senior executive leadership, the ED ensures the delivery of a high-performing, standardized, and patient-centered clinical trials infrastructure that enables equitable access to innovative therapies across all sites of care. This leader is accountable for optimizing trial activation, enrollment, execution, and closeout while maintaining the highest standards of quality, regulatory compliance, and patient safety. The ED partners closely with physician leaders, principal investigators, sponsors, and administrative stakeholders to expand research capabilities, accelerate accrual, and enhance the overall patient and provider experience.
ESSENTIAL FUNCTIONS
Enterprise Strategy & Operational Leadership
- Define and execute a comprehensive, systemwide strategy for clinical trial operations that aligns with Wilmot’s strategic priorities and NCI designation requirements.
- As the primary operational leader, lead the design, standardization, and scaling of workflows, infrastructure, and technologies to support efficient and high-quality trial delivery.
- Drive integration of clinical research into care delivery models to ensure trials are accessible, scalable, and embedded across all regions.
- Establish governance structures, performance dashboards, and reporting mechanisms to ensure transparency, accountability, and continuous improvement.
- Represent clinical trial operations in executive forums and contribute to enterprise-wide strategic planning initiatives.
- Translate scientific and programmatic priorities set by the cancer center director and associate director for clinical research into actionable operational strategies.
- Anticipate and respond to shifts in the clinical trials landscape (e.g. NCTN, NCORP, ETCTN, industry-sponsored, IIT) to keep the portfolio competitive and diversified.
Stakeholder Engagement & Collaboration
- Build and sustain strong partnerships with disease program leadership, principal investigators, clinical and operational leaders, foundation leadership, and industry sponsors.
- Serve as a key liaison between research, clinical operations, finance, and administrative functions to ensure alignment and shared accountability.
- Strengthen external relationships with sponsors and partners to enhance study opportunities, improve activation timelines, and expand the research portfolio.
- Partner closely with the associate director for clinical research on scientific prioritization, protocol portfolio balance, and trial accrual strategy.
- Collaborate with the associate director for administration on applicable budget alignment, space planning, and institutional resource allocation.
Clinical Research Execution & Quality Oversight
- Establish and enforce systemwide standards for study start-up, conduct, monitoring, and closeout, ensuring compliance with all regulatory and accreditation requirements with FDA, ICH-GCP, NCI. OHRP, and institutional regulatory office.
- Oversee the development and implementation of standard operating procedures (SOPs), quality assurance programs, and audit readiness processes.
- Ensure consistent delivery of safe, ethical, and high-quality research, with a strong focus on patient experience and outcomes.
- Identify operational bottlenecks and implement scalable solutions to improve trial activation speed, enrollment, and data integrity.
- Serve as a liaison between the CTO and supporting institutional entities, including IRB, PRMC, Pharmacy, Tissue bank, Pathology, Radiology, and DSMC.
- Oversee clinical trial agreement negotiation, budget development, and coverage analysis in coordination with Sponsored Programs and Administration.
- Maintain oversight of clinical research information systems (CTMS, OnCore, EDC platforms etc. to ensure accurate, real-time portfolio tracking.
People & Talent Leadership
- Provide executive oversight of clinical research personnel across the system, including workforce planning, recruitment, retention, and succession planning.
- Foster a culture of accountability, collaboration, and continuous learning among research staff and leadership.
- Develop and implement comprehensive onboarding, training, and professional development programs to ensure staff are highly skilled and compliant with evolving regulations.
- Coach and mentor leaders to build a strong, sustainable pipeline of talent.
- Establish career ladders, competency frameworks and professional development pathways to strengthen workforce capability and retention.
Financial Stewardship & Growth
- Oversee the financial performance of clinical trial operations, including budgeting, forecasting, and resource allocation and report financial performance and portfolio growth metrics to cancer center leadership and relevant oversight committees.
- Identify opportunities to improve operational efficiency, optimize cost structures, and enhance revenue generation through research activities.
- Collaborate with finance and business development teams to evaluate and launch new programs, services, and partnerships that support research growth.
- Monitor per-patient trial costs and negotiate sponsor budgets to ensure financial sustainability of trial conduct.
Performance Improvement, Analytics & Innovation
- Define key performance indicators (KPIs) and leverage data analytics to monitor performance, identify trends, and inform decision-making.
- Lead systemwide quality and performance improvement initiatives aimed at increasing trial access, enrollment, and operational efficiency.
- Champion innovation in clinical trial delivery, including decentralized trials, digital tools, and novel care models.
- Ensure alignment of trial portfolios with patient population needs, organizational capabilities, and strategic priorities.
- Benchmarks performance against peer NCI-designated cancer centers and national best practices.
Clinical Research Care Coordination & Access
- Promote a coordinated, patient-centered approach to clinical research across all sites, ensuring seamless integration with clinical care pathways.
- Align trial availability with disease prevalence, community needs, and site capabilities to improve equitable access to research in collaboration with marketing/communication to raise awareness of trial availability among patients, providers, and the community.
- Partners with clinical and administrative leaders to remove barriers to participation and enhance patient engagement in trials.
MINIMUM EDUCATION & EXPERIENCE
- Master's degree and 5 years of relevant experience (or Ph D) required
- Or equivalent combination of education and experience
- 2 years in a managerial capacity required
KNOWLEDGE, SKILLS AND ABILITIES (preferred)
- 10+ years of clinical trial experience with 5+ years of managerial level with significant experience in an academic medical center or NCI-designated cancer center setting.
- Evidence of progressive leadership experience
- Knowledge and/or experience with NCI CCSG expectations
- Direct experience with clinical trial management systems such as OnCore, Velos, Clinical Conductor, etc.
- Previous experience coordinating and managing oncology clinical research programs
- Extensive knowledge in clinical research operations and associated regulations governing clinical research
- Strong interpersonal and relationship-building skills to engage physicians, scientists, administrators, and external sponsors
- Strong financial acumen, including budget development, forecasting, and cost/revenue management
- Exceptional strategic thinking and ability to translate institutional priorities into operational execution
- Strong communication skills (verbal and written)
- Ability to provide leadership and promote collaboration
- Possess exceptional time management skills
- Excellent interpersonal skills
The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University’s Mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.
See all 743+ E-3 Visa Clinical Research Director Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new E-3 Visa Clinical Research Director Jobs.
Get Access To All JobsTips for Finding E-3 Visa Sponsorship in Clinical Research Director
Align your credentials to FDA-regulated trial standards
U.S. employers hiring Clinical Research Directors expect familiarity with FDA 21 CFR Part 312 and ICH E6 GCP. Before applying, reframe your Australian TGA experience in terms of FDA equivalency so hiring managers and DOL reviewers see a direct specialty occupation fit.
Target CROs and pharma companies with LCA history
Contract research organizations and mid-to-large pharmaceutical companies file LCAs regularly and have established HR processes for E-3 visa sponsorship. Searching DOL's Foreign Labor Application Gateway disclosure data by job title filters these employers from those with no filing history.
Address E-3 sponsorship early in recruiter conversations
Many U.S. recruiters default to H-1B visa when they hear 'visa sponsorship.' Clarify upfront that you hold Australian citizenship and that E-3 requires only an LCA and consular appointment, with no lottery and no cap exposure, so the employer's cost and timeline are significantly lower.
Prepare a specialty occupation support letter with your offer
Consular officers assess whether a Clinical Research Director role genuinely requires a bachelor's degree or higher in a specific field. Ask your employer to draft a letter linking the job duties to your degree discipline before your DS-160 appointment, not after a 221(g) administrative processing delay.
Use Migrate Mate's E-3 filing service for your LCA and paperwork
The LCA must be DOL-certified before you can attend your consular interview. Use Migrate Mate's E-3 filing service to handle your LCA submission, prevailing wage compliance, and consulate preparation so nothing stalls your start date with your new employer.
Negotiate your E-3 renewal cycle into your employment contract
E-3 status is granted in two-year increments and requires a new LCA each renewal. Before you sign your offer, confirm the employer will sponsor renewals and that your role title and duties won't shift enough between cycles to trigger a new specialty occupation assessment at the consulate.
E-3 Visa Clinical Research Director: Frequently Asked Questions
How do I find Clinical Research Director jobs that offer E-3 visa sponsorship?
Migrate Mate is built specifically for Australian professionals searching for U.S. roles with E-3 sponsorship. You can filter by job title and industry to find Clinical Research Director positions at employers who already understand E-3 requirements. Because E-3 has no cap or lottery, any employer willing to file an LCA with the DOL can sponsor you, which broadens the field considerably compared to H-1B-only searches.
How much does it cost to get an E-3 visa?
Migrate Mate's E-3 filing service covers the entire process for $499, including the Labor Condition Application, visa document preparation, and consulate appointment guidance. Traditional immigration lawyers charge $2,000–$5,000+ for the same work. The E-3 has less paperwork than most work visas, so paying thousands for legal help is usually unnecessary.
Does a Clinical Research Director role qualify as a specialty occupation for E-3 purposes?
Yes, Clinical Research Director positions consistently meet the E-3 specialty occupation standard because they require a bachelor's degree or higher in life sciences, medicine, pharmacy, or a related discipline as a normal entry requirement. The role involves applying specialized knowledge across protocol design, regulatory submissions, and trial management, which satisfies the DOL's definition. Roles that blend clinical and general management functions may require a stronger degree-nexus justification letter from the employer.
How does the E-3 visa compare to the H-1B for Clinical Research Directors?
The E-3 is available only to Australian citizens, but it has two major structural advantages over the H-1B for this role: there is no annual cap and no lottery, so your start date depends on consulate scheduling rather than a random draw. H-1B registration opens once a year in March, and selection is not guaranteed. E-3 applications can be filed year-round and are processed at the consulate, typically within a few weeks of your interview.
What happens to my E-3 status if I change employers mid-trial or take a new role?
E-3 status is employer-specific, so a change in employer requires a new LCA filed by the incoming employer and a new consular stamp before you begin working for them. You cannot port E-3 status the way some other visa categories allow. If you're transitioning between CROs or moving from a sponsor company to an academic medical center, build in enough lead time for the new LCA to be DOL-certified, which the DOL targets within seven business days under standard processing.