Lead CRA- International Observational Studies

Lead CRA
- International Observational Studies

United States

Trending
• Job Identification 340350
• Job Category Consulting
• Job Type Regular Employee
• Does this position require a security clearance? No
• Years 3 to 5+ years
• Additional Info Visa / work permit sponsorship is not available for this position
• Applicants are required to read, write, and speak the following languages English
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!

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 elevate 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 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,…