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. Conducting operations in more than 90 countries, Fortrea is transforming drug and device development for partners and patients across the globe.

Our Functional Service Provider (FSP) Team is currently seeking a remote based Senior Clinical Study Assistant to support one of our top sponsors.

This individual will independently perform tasks related to planning, and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan. This will include providing day-to- day clinical activities including regulatory inspection readiness, collaborating with Clin Ops/Study Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities. Will perform departmental tasks as needed. 

This is a full-time, remote based position, open to anyone in the United States.

Responsibilities

• Review and/or approval of study documentation, including essential document packets, study plans, informed consent forms, etc. 
• Supporting/oversight of risk-based monitoring. 
• Attendance of key team meetings as required; may make presentations (e.g., data, etc.). 
• Supporting regulatory inspection readiness (e.g., preparation of materials and/or participation during regulatory inspections.) 
• Support clinical trial systems (e.g., CTMS/TMF/COMPASS associated activities for selected studies 
• Supporting vendor contract administration as required. 
• Support with vendor management.
• Support study close-out activities, e.g., financial reconciliation. 
• Supporting additional ad-hoc activities as needed, as agreed with Manager(s). 
• Provide support for departmental tasks, including but not limited to: 
• Maintaining knowledge of systems and processes. 
• Attending internal and external training as needed and maintaining up-to-date training record. 

Qualifications

• Bachelor’s degree or equivalent international degree required. 
• 4 + years’ experience in pharmaceutical industry and/or clinical research organization (FSP program).
• Experience in Phase 2 and 3 studies and global/international studies.
• Experience working across multiple therapeutic areas (including oncology) is advantageous. 
• Experience managing a high number of sites (250-400).
• Experience with ICF review, escalation and tracking.
• Monitoring review experience.
• Writing meeting minutes.
• Managing study team lists, budget coordination, and inspection readiness.
• Experience with storyboard, SOP list updates, FAQ management and communication tracking with CROs and sites.
• Experience with assisting with vendor management.
• Proficiency with Veeva Vault.
• Feasibility and site selection experience (a plus).
• Experience with reviewing reports, study plans, and communication plans.
• Skills 
• Knowledge in global/regional regulatory and compliance requirements for clinical research. 
• Demonstrated excellence in task management and cross-functional collaboration. 
• Excellent communication skills. 
• Excellent teamwork, organizational, detail-oriented, interpersonal, and problem-solving skills. 
• Fluent business English (oral and written). 

Compensation and Benefits

Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including but not limited to:

• Medical, Dental, Vision, Life, STD/LTD (multiple insurance carriers)
• 401(K)
• Paid time off – unlimited flex package  
• Employee recognition awards

Target Pay Range: $60,000 to $75,000

**Position fully remote**

#LI - Remote

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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