Business Analyst

Role Overview

The Business Analyst at Biofusion will support various clinical operations projects, ensuring smooth workflow and adherence to timelines. The position requires coordinating closely with clinical teams and external vendors to help advance clinical trials effectively.

Key Responsibilities

• Assist in devising and implementing operational strategies to facilitate clinical projects.
• Track project schedules, milestones, and deliverables to ensure timely completion.
• Collaborate and maintain communication with external vendors and internal teams.
• Lead and oversee clinical research projects, including developing study protocols and managing budgets.
• Supervise compliance with ethical regulations throughout studies.
• Mentor junior personnel and research staff to foster team development.
• Coordinate daily clinical trial operations and support patient recruitment and retention strategies.
• Maintain accurate study documentation and facilitate communication across project teams.
• Manage clinical trial data processes ensuring accuracy, integrity, and adherence to regulatory standards.
• Prepare and present data reports for stakeholders, collaborating with cross-functional teams.
• Ensure regulatory compliance including Good Clinical Practice (GCP) and FDA regulations.
• Manage relationships with investigators and site personnel, monitoring all aspects from trial initiation through completion.

Candidate Requirements

• Bachelor's degree in Health Sciences, Life Sciences, Nursing, Computer Science or related fields is generally required; advanced degrees (Master's or PhD) are preferred for senior roles.
• Relevant experience ranging from 1 to 5+ years in clinical operations, research management, data management, or clinical trial coordination depending on seniority.
• Strong organizational skills, with a proven ability to manage multiple tasks and projects simultaneously.
• Excellent communication and interpersonal skills essential for effective collaboration and stakeholder management.
• Ability to work both independently and as part of a multidisciplinary team.
• Knowledge and experience with clinical trial processes, regulatory standards including GCP, FDA regulations, data management software, and statistical analysis tools are highly desirable.
• Leadership qualities with demonstrated problem-solving abilities for senior roles.

Additional Information

Applicants may hold roles such as Clinical Operations Specialist, Clinical Research Manager, Clinical Trial Coordinator, Clinical Data Manager, or Clinical Research Associate depending on qualifications and experience. These positions encompass a range of responsibilities from operational support to research leadership and data oversight.

No salary or stipend details have been disclosed. The position is full-time and requires presence on-site at the San Diego, CA location.