Sr. CSA

$60,000 - $75,000/Yr

Fortrea Inc. - Durham, NC

Part-time,Full-time - Mid Level

Remote - Durham, NC

5,001-10,000 employees

Professional, Scientific, and Technical Services

About the position

Fortrea is seeking a Senior Clinical Study Assistant to support clinical studies for pharmaceutical, biotechnology, and medical device customers. This remote position involves independently performing tasks related to the planning and execution of clinical studies, ensuring regulatory compliance, and collaborating with various stakeholders to facilitate clinical activities.

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.

Requirements

• 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.

Nice-to-haves

• 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).

Benefits

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