Lead CRA- International Observational Studies

Oracle•United States,

1d•$74,100 - $148,300

About The Position

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!

Requirements

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).
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 team work, 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.

Nice To Haves

Additional languages are considered a strong asset.

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.