Oracle · 8 hours ago
Lead Clinical Research Associate
United States
Full-time
Remote
Senior Level, Lead/Staff
$71K/yr - $141K/yr
3+ years expOracle is a global leader in cloud solutions, and they are seeking a Senior Lead Clinical Research Associate to drive success as part of their Non-interventional Study team. The role involves overseeing clinical research activities, ensuring regulatory compliance, and mentoring a team of Clinical Research Associates.
Data GovernanceData ManagementEnterprise SoftwareInformation TechnologySaaSSoftware
Responsibilities
Drive study start-up: Develop feasibility questionnaires, identify and assess potential study sites, and ensure proper site selection in close collaboration with Project Managers and Sponsors
Oversee contracts and budgets: Review and track site contracts and budgets for study specifications, working closely with CRA and contracting teams, and involve contract specialists for legal matters
Ensure regulatory compliance: Coordinate with regulatory teams and CRAs to ensure all ethical committee (EC) requirements are met and support the preparation and submission of essential site documents
Lead study site management: Supervise site activation and ongoing management, including monitoring activities from feasibility to close-out, in line with GCP, SOPs, study protocols, and plans
Train and coordinate CRAs: Oversee, mentor, and train a cross-country team of Clinical Research Associates, develop project-specific training materials, and ensure delivery of high-quality site management
Monitor progress and quality: Create and maintain study trackers, monitor CRA activities and site deliverables, identify and escalate critical issues, and review/approve monitoring reports
Foster team collaboration: Act as the key point of contact between the study team, Sponsor, study sites, and CRAs, supporting strong working relationships and continuous process improvement
Travel for site initiations, closures or quality visits: Be available to travel to clinical sites to train and monitor site activities as needed. While there is no guaranteed travel, flexibility is required
Qualification
Required
Bachelor's degree in Life Sciences, Medical Science, Pharmacy, Public Health, or equivalent, with a minimum of three years' hands-on clinical research experience
At least 3 years of experience as a CRA, including site initiation, Trial Master File (TMF) management, and site monitoring for both clinical and non-interventional studies
Outstanding spoken and written proficiency in English (C1 level minimum). Additional languages are considered a strong asset
Comfort with MS Office, EDC, CTMS experience and willingness to learn and handle various technical systems and tools
Exceptional organizational and problem-solving skills, strong cross-cultural teamwork, initiative in process optimization, and the ability to manage competing priorities in a fast-paced environment
Experience reviewing site contracts, budget and invoices
Ability to work independently with careful, precise, and thorough execution of complex tasks
Benefits
Medical, dental, and vision insurance, including expert medical opinion
Short term disability and long term disability
Life insurance and AD&D
Supplemental life insurance (Employee/Spouse/Child)
Health care and dependent care Flexible Spending Accounts
Pre-tax commuter and parking benefits
401(k) Savings and Investment Plan with company match
Paid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) position. Accrued Vacation is provided to all other employees eligible for vacation benefits. For employees working at least 35 hours per week, the vacation accrual rate is 13 days annually for the first three years of employment and 18 days annually for subsequent years of employment. Vacation accrual is prorated for employees working between 20 and 34 hours per week. Employees working fewer than 20 hours per week are not eligible for vacation.
11 paid holidays
Paid sick leave: 72 hours of paid sick leave upon date of hire. Refreshes each calendar year. Unused balance will carry over each year up to a maximum cap of 112 hours.
Paid parental leave
Adoption assistance
Employee Stock Purchase Plan
Financial planning and group legal
Voluntary benefits including auto, homeowner and pet insurance
Company
Oracle
Oracle is an integrated cloud application and platform services that sells a range of enterprise information technology solutions.
10001+ employees
H1B Sponsorship
Oracle has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1271)
2024 (846)
2023 (995)
2022 (1192)
2021 (985)
2020 (755)
Funding
Current Stage
Public CompanyTotal Funding
$25.75BKey Investors
Sequoia Capital
2025-09-24Post Ipo Debt· $18B
2025-02-03Post Ipo Debt· $7.75B
1986-03-12IPO
Leadership Team
Esteban Rubens
Healthcare Field CTO
G
Gerard Warrens
Field CTO, Business Strategy and Transformative Technologies
Recent News
2026-01-17
2026-01-16
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