Quality Assurance Engineer

Job Overview

Biofusion is seeking a Quality Assurance Engineer dedicated to supporting clinical operations across multiple projects. The role involves developing operational strategies, monitoring project timelines and deliverables, and coordinating with external vendors to ensure smooth execution of clinical trials.

Key Responsibilities

• Provide support to clinical operations teams during various projects.
• Develop and implement strategies to improve operational effectiveness.
• Track project milestones to ensure on-time delivery of objectives.
• Collaborate effectively with external vendors and partners.
• Lead and manage clinical research initiatives, including study protocol creation and budget development.
• Ensure compliance with ethical standards throughout clinical studies.
• Mentor junior colleagues and research staff to foster growth and development.
• Coordinate daily clinical trial activities, including patient recruitment, retention, and documentation management.
• Oversee data management processes to guarantee data accuracy and integrity.
• Facilitate communication between multiple teams involved in clinical research.
• Manage clinical studies from initiation through completion, ensuring regulatory compliance and coordination with investigators and site personnel.

Qualifications

• Bachelor's degree in Health Sciences, Life Sciences, Nursing, Computer Science, or a related discipline required for various roles within the team.
• Master's or PhD degrees preferred for senior positions such as Clinical Research Manager, Clinical Data Manager, or Senior Clinical Research roles.
• Experience ranging from 1 to over 5 years in clinical operations, research management, data management, or clinical trial coordination required depending on the role.
• Comprehensive knowledge of clinical trial processes including GCP, FDA regulations, regulatory submissions, and ethical guidelines.
• Strong organizational, multitasking, interpersonal, and leadership abilities.
• Proficiency with statistical software and clinical data management tools beneficial for data-focused roles.

Additional Details

This position is full-time and requires onsite presence in Orlando, Florida. Candidates must be able to work independently as well as collaboratively in team environments. Excellent communication and problem-solving skills are essential to succeed. Familiarity with clinical trial regulations, regulatory standards, and data integrity principles is highly valued.