Senior Clinical Trial Associate – Sr. CTA

This is a fully remote position, open to applicants in United States.

📋 Description

• Provide support to Clinical Operations and project teams throughout all stages of clinical projects.

• Collaborate with Clinical teams, site personnel, and vendors both in the U.S. and globally to assist with project-specific tasks and overall management of clinical trials.

• Oversee and manage user access requests and deactivation for study systems.

• Organize materials for internal and external meetings.

• Distribute safety alerts and pertinent documents as necessary.

• Keep contact information for study teams and vendors up to date.

• Aid in the planning, organizing, and execution of study-specific meetings; prepare and circulate agendas, minutes, and updates.

• Review, format, and finalize study-related templates, plans, and manuals as needed.

• Assist in managing clinical trial insurance.

• Direct inquiries and requests from Clinical Research Organizations/study teams for resolution.

• Engage in clinical data review as required.

• Ensure comprehensive documentation for the Trial Master File and perform ongoing quality checks along with SOP/ICH-GCP compliance reviews.

• Manage the routing, tracking, and filing of Clinical documents.

• Assess site Clinical regulatory documentation for completeness and dates as necessary.

• Create and maintain study-related trackers and analyze or update tracker data.

• Support Study Team Leads and Operational Team Leads with additional assigned responsibilities.

⛳️ Requirements

• A Bachelor’s degree in a relevant field is strongly preferred, or a combination of education and applicable work experience may be taken into consideration.

• At least 2+ years of experience in the biotech/pharmaceutical industry or clinical trial management.

• Familiarity with the drug development process and knowledge of ICH-GCP is advantageous.

• Strong interpersonal, organizational, and planning abilities.

• Exceptional verbal and written communication skills.

• Self-motivated and proactive individual with the capacity to take charge of tasks and execute them effectively.

• Ability to recognize opportunities for increased efficiency across studies.

• Willingness to travel up to 35% of the time.

🏝️ Benefits

• Opportunity for annual bonuses.

• Comprehensive medical insurance.

• Dental insurance coverage.

• Vision insurance benefits.

• Life insurance options.

• Accidental death and dismemberment (AD&D) insurance.

• Short-term disability insurance.

• Long-term disability insurance.

• 401(k) plan with matching contributions.

• Stock options available.

• Flexible non-accrual paid time off.

• Parental leave benefits.