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Oracle · 6 hours ago

Lead Clinical Research Associate

United States

Full-time

Remote

Senior Level, Lead/Staff

$71K/yr - $141K/yr

3+ years exp

Oracle is a world 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 managing study sites globally.

Data GovernanceData ManagementEnterprise SoftwareInformation TechnologySaaSSoftware

No H1B

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

Clinical research expertiseRegulatory complianceSite managementFinancial managementTechnical proficiencyCommunication skillsAttention to detailOrganizational skillsProblem-solving skillsTeamwork

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