Lead CRA- International Observational Studies

Job Description

With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to join us!

As a global leader we're looking for a Senior Lead Clinical Research Associate (CRA) to drive success as part of our Non-interventional Study team.

Join Oracle as a Lead CRA and make a real impact by guiding teams, ensuring top-quality clinical research, and driving groundbreaking projects on a global scale!

What you will do

As a Senior Lead Clinical Research Associate at Oracle, you will:

• 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.

Required Experience

• 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.

Responsibilities

What you will do

As a Senior Lead Clinical Research Associate at Oracle, you will:

• 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.

Qualifications

Disclaimer:

Certain U.S. based or U.S. customer or client-facing roles may be required to comply with applicable requirements, such as immunization/occupational health mandates, and/or drug testing requirements.

Range and benefit information provided in this posting are specific to the stated locations only

US: Hiring Range in USD from: $74,100 to $148,300 per annum. May be eligible for bonus and equity.

Oracle 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 business. Candidates are typically placed into the range based on the preceding factors as well as internal peer equity.

Oracle US offers a comprehensive benefits package which includes the following:

1. Medical, dental, and vision insurance, including expert medical opinion
2. Short term disability and long term disability
3. Life insurance and AD&D
4. Supplemental life insurance (Employee/Spouse/Child)
5. Health care and dependent care Flexible Spending Accounts
6. Pre-tax commuter and parking benefits
7. 401(k) Savings and Investment Plan with company match
8. 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.
9. 11 paid holidays
10. 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.
11. Paid parental leave
12. Adoption assistance
13. Employee Stock Purchase Plan
14. Financial planning and group legal
15. Voluntary benefits including auto, homeowner and pet insurance

The role will generally accept applications for at least three calendar days from the posting date or as long as the job remains posted. Career Level - IC3