Clinical Research Associate

About QED Therapeutics & BridgeBio Pharma

QED Therapeutics, an affiliate of BridgeBio Pharma, focuses on developing targeted treatments for FGFR-driven skeletal dysplasias, particularly Achondroplasia. Achondroplasia is the most common form of genetically-driven short stature, which causes potentially debilitating medical complications. With our experimental therapeutic candidate, infigratinib, we seek to provide an option to children living with Achondroplasia and their families.

Our business is inspired by our values:

• PUT PATIENTS FIRST
• LET SCIENCE SPEAK
• EVERY MINUTE COUNTS
• THINK INDEPENDENTLY
• BE RADICALLY TRANSPARENT

FGFR=fibroblast growth factor receptor.

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs.

Our focus on scientific excellence and rapid execution aims to translate today's discoveries into tomorrow's medicines. We have U.S. offices in San Francisco, Palo Alto, Raleigh, and with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zug, Switzerland, and are expanding across Europe.

To learn more about our story and company culture, visit us at https://www.qedtx.com/ | https://bridgebio.com
Who You Are

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. Responsible for performing study activities, including but not limited to communications with clinical site staff and clinical vendors, tracking of study samples, supporting the filing and monitoring of the Trial Master File (TMF), creation and maintenance of study documents and tools, and review monitoring trip reports. In addition, participate in the training and oversight of clinical vendor and study site staff personnel and development of standardized clinical oversight/tracking tools. The individual in this role will not monitor study data at the clinical sites.
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%)

No matter your role at BridgeBio, successful team members are:

• Patient Champions, who put patients first and uphold strict ethical standards
• Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
• Truth Seekers, who are detailed, rational, and humble problem solvers
• Individuals Who Inspire Excellence in themselves and those around them
• High-quality executors, who execute against goals and milestones with quality, precision, and speed

Education, Experience & Skills 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)

What We Offer

• 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

At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.

Salary

$115,000-$145,000 USD