Clinical Research Associate

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement…read on

In 2015, we pioneered a “Moneyball for biotech” approach, pooling projects and promising early-stage research from academia under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare diseases and develop life-changing medicines for patients with unmet needs as fast as humanly possible. 

Together we define white space, push boundaries and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma.

Affiliate Overview

QED Therapeutics, an affiliate within 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.

What You’ll Do

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%)

Where You’ll Work

• This a U.S-based remote role that will require quarterly, or as needed visits to our San Francisco, CA Office or Palo Alto, CA Office

Who You Are

• 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)

Rewarding Those Who Make the Mission Possible

We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. 

Financial Benefits:

• Market leading compensation 
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals

Health & Wellbeing:

• Comprehensive health care with 100% premiums covered - no cost to you and dependents
• Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions)
• Hybrid work model - employees have the autonomy in where and how they do their work 
• Unlimited flexible paid time off - take the time that you need
• Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents
• Flex spending accounts & company-provided group term life & disability 
• Subsidized lunch via Forkable on days worked from our office

Skill Development & Career Paths:

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility
• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, Spring Health & BetterUp Coaching
• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities