Lead CRA- International Observational Studies
Behavioral Health Market Context
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Benefits
US: Hiring Range in USD from: $70,600 to $141,200 per annumMay be eligible for bonus and equityOracle maintains broad salary ranges for its roles in order to account for variations in knowledge, skills, experience, market conditions and locations, as well as reflect Oracle's differing products, industries and lines of businessOracle US offers a comprehensive benefits package which includes the following:Medical, dental, and vision insurance, including expert medical opinionShort term disability and long term disabilityLife insurance and AD&DSupplemental life insurance (Employee/Spouse/Child)Health care and dependent care Flexible Spending AccountsPre-tax commuter and parking benefits401(k) Savings and Investment Plan with company matchPaid time off: Flexible Vacation is provided to all eligible employees assigned to a salaried (non-overtime eligible) positionAccrued Vacation is provided to all other employees eligible for vacation benefitsFor 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 employmentVacation accrual is prorated for employees working between 20 and 34 hours per weekEmployees working fewer than 20 hours per week are not eligible for vacation11 paid holidaysPaid sick leave: 72 hours of paid sick leave upon date of hireRefreshes each calendar yearUnused balance will carry over each year up to a maximum cap of 112 hoursPaid parental leaveAdoption assistanceEmployee Stock Purchase PlanFinancial planning and group legalVoluntary benefits including auto, homeowner and pet insuranceThat’s why we’re committed to growing a workforce that promotes opportunities for all with competitive benefits that support our people with flexible medical, life insurance, and retirement options23 more items(s)
Qualifications
- •Education : Bachelor’s degree in Life Sciences, Medical Science, Pharmacy, Public Health, or equivalent, with a minimum of three years’ hands-on clinical research experience
- •Clinical research expertise : 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
- •Communication skills : Outstanding spoken and written proficiency in English (C1 level minimum)
- •Additional languages are considered a strong asset
- •Technical proficiency : Comfort with MS Office, EDC, CTMS experience and willingness to learn and handle various technical systems and tools
- •Personal qualities : Exceptional organizational and problem-solving skills, strong cross-cultural team work, initiative in process optimization, and the ability to manage competing priorities in a fast-paced environment
- •Financial management: Experience reviewing site contracts, budget and invoices
- •Attention to detail : Ability to work independently with careful, precise, and thorough execution of complex tasks
- •Certain US customer or client-facing roles may be required to comply with applicable requirements, such as immunization and occupational health mandates
- •6 more items(s)
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
- •Conduct Feasibility Assessments: Organize, identify and manage the feasibility process with CRA's
- •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
- •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
- •Conduct Feasibility Assessments: Organize, identify and manage the feasibility process with CRA's
- •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
- •17 more items(s)
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