As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas. With over 19,000 staff conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.
Are you passionate about advancing clinical research and making a real impact on healthcare Do you thrive in dynamic environments and enjoy working with cutting-edge research teams If so, we have an exciting opportunity for you!
At Fortrea, we are dedicated to improving patient outcomes through innovative clinical trials and research. We are currently seeking a talented and experienced Senior Clinical Research Associate (SCRA) to join our team and help drive our mission forward.
What You'll Do
Site Monitoring & Management: Oversee all aspects of study site monitoring, including routine visits and closeouts, study file maintenance, and initiation visits. Collaborate with vendors and manage site activities according to project plans.
Patient Safety & Data Integrity: Ensure patient protection through adherence to informed consent procedures and protocol requirements. Verify data integrity by reviewing source documents and CRFs, and monitor for missing or implausible data.
Efficiency & Compliance: Perform monitoring tasks efficiently, manage travel expenses wisely, and ensure audit readiness. Prepare accurate and timely trip reports.
Leadership & Coordination: Manage small projects, serve as lead monitor for protocols, assist in establishing monitoring plans, and review trip reports. Participate in developing protocols, CRFs, and clinical trial reports.
Communication & Collaboration: Organize and present at Investigator Meetings, interact with internal teams to evaluate needs and timelines, and act as a contact for trial supplies and vendors.
Regulatory & Administrative Tasks: Handle registry management, feasibility work, QC visits, investigator recruitment, EC submissions, regulatory notifications, and study budget negotiations. Track and follow up on SAE reporting.
What We're Looking For
Experience: Minimum of 4 years in clinical monitoring, with advanced skills in site monitoring, site management, and registry administration. Strong understanding of SAE reporting.
Skills: Excellent planning, organization, and problem-solving abilities. Advanced computer skills and proficiency in a range of software packages. Strong verbal and written communication skills. Ability to train and supervise junior staff and resolve project-related issues.
Education: University or college degree, or certification in a related allied health profession (e.g., nursing licensure). Thorough knowledge of regulatory requirements and the drug development process. Fluent in local office language and English.
Why Fortrea
Innovative Projects: Work on groundbreaking clinical research that is shaping the future of healthcare.
Professional Growth: Opportunities for continuous learning and career advancement.
Supportive Environment: Collaborate with a team of dedicated and passionate professionals.
Competitive Compensation: Attractive salary and benefits package, including health insurance, retirement plans, and more.
Ready to Make a Difference
Join us in our mission to improve patient lives through innovative clinical research. Apply today and be part of a team that's making a real impact!
Fortrea is actively seeking motivated problem-solvers and creative thinkers who share our passion for overcoming barriers in clinical trials. Our unwavering commitment is to revolutionize the development process, ensuring the swift delivery of life-changing ideas and therapies to patients in need. Join our exceptional team and embrace a collaborative workspace where personal growth is nurtured, enabling you to make a meaningful global impact. For more information about Fortrea, visit www.fortrea.com.
Fortrea is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, Fortrea strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic. We encourage all to apply.
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