BridgeBio is hiring a
Sr. Clinical Research Associate, Remote - United States

Summary

The job is for a Clinical Research Associate at QED Therapeutics, an affiliate of BridgeBio Pharma. The role involves supporting clinical studies, collaborating with the Clinical Operations team, and participating in the development and management of standardized clinical oversight/tracking tools.

Requirements

• Bachelor’s degree or equivalent training and experience (i.e., RN/PA, BSN degree)
• Minimum 4-6 years of clinical study experience
• Experience supporting global studies in a fast-paced environment
• Success in working with CROs and vendors
• Excellent communication skills and ability to achieve milestones in a team environment
• Ability to communicate and collaborate respectfully in a remote environment

Responsibilities

• Support all aspects of clinical studies from initiation, planning, execution, maintenance, and close-out
• Take a leadership role in the assigned site and study or vendor management activities
• Provide oversight of contract vendors and Clinical Research Organization activities
• Proactively identify issues for escalation, participate in problem-solving and implementation of risk mitigation
• Coordinate and maintain relevant tracking systems for subject screening, enrollment, study visits, data entry, query resolution, and related metrics
• Perform co-monitoring visits with CRO, as needed, to provide oversight during site qualification, site initiation, routine monitoring, and close-out visits
• Participate in the development, review, and implementation of departmental SOPs and processes
• Participate in the development of study-related clinical documents, including informed consent forms, site training materials, CRFs, clinical monitoring plans, and source document templates
• Assist in the preparation of study protocols, IBs, and regulatory submissions

Preferred Qualifications

Knowledge of clinical trial documentation and regulatory requirements related to trial master files is preferred

Benefits

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
• A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
• An unyielding commitment to always putting patients first. Learn more about how we do this here
• A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
• A place where you own the vision – both for your program and your own career path
• A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
• Access to learning and development resources to help you get in the best professional shape of your life
• Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
• Flexible PTO
• Rapid career advancement for strong performers
• Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time
• Partnerships with leading institutions
• Commitment to Diversity, Equity & Inclusion