Clinical Research Associate Palo Alto, California, United States

About the position QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly Achondroplasia. The Clinical Research Associate collaborates within the Clinical Operations team to support the timely conduct of clinical studies according to protocols, Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), and all applicable regulations governing the conduct of clinical trials. Responsibilities include performing study activities, communications with clinical site staff and clinical vendors, tracking study samples, supporting the filing and monitoring of the Trial Master File (TMF), and participating in the training and oversight of clinical vendor and study site staff personnel.

Responsibilities

• Work closely with the Associate Director, Clinical Operations to support all aspects of clinical studies from initiation, planning, execution, maintenance, and close-out.
• Take a leadership role in the assigned site and study management activities, including ICFs, regulatory submissions, site activations, monitoring reports, and study plans.
• Act as a bridge between QED and the Investigators/study sites and contribute to building solid sponsor-site relationships.
• Provide oversight of contract vendors and Clinical Research Organization activities to ensure all are conducted according to study plans, timelines, budgets, relevant SOPs, and compliance with GCPs, FDA regulation, and ICH/GCP guidelines.
• Track laboratory samples and clinical supplies as needed.
• 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.
• Participate in the development of study-related clinical documents, including informed consent forms, site training materials, CRFs, clinical monitoring plans, source document templates, and data audit worksheets.
• Assist in the preparation of study protocols.
• Conduct quality reviews of the TMF and take a leadership approach in the filing, tracking, and maintenance of the TMF.
• Support the organization in maintaining a work environment focused on quality, fostering learning, respect, open communication, collaboration, integration, and teamwork.
• Additional operations activities may be assigned as appropriate.
• Travel as required to carry out responsibilities (up to 10%).

Requirements

• BSc in natural or health sciences (biology, pharmacology, pharmaceutical sciences, or equivalent) or relevant industry experience in lieu.
• Minimum 4-6 years of experience within clinical operations, study coordinator, or similar field; Citi training preferred.
• Knowledge of clinical trial documentation and regulatory requirements related to TMFs is preferred.
• Ability to communicate and collaborate respectfully in a remote environment.
• Effective communication, interpersonal skills, and true team player.
• Decision-making abilities, but knows when to ask for advice.
• Structured and organized with strong attention to detail and excellent organizational skills.
• Proactively identifies problems and generates possible solutions to present to a team.
• Eager to learn and balance multiple tasks simultaneously.
• Excellent verbal and written communication skills.
• Success in working with CROs and vendors.
• Ability to achieve milestones in a team environment.
• Proficient in M.S. Office Suite (Excel, Word, PowerPoint, Outlook).

Benefits

• Patient Days, where we hear directly from individuals living with the conditions we are seeking to impact.
• 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.
• A de-centralized model that enables our program teams to focus on advancing science and helping patients.
• A place where you own the vision - both for your program and your own career path.
• A collaborative, fast-paced, data-driven environment.
• Access to learning and development resources.
• 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.

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