Clinical Trial Associate

Navire Pharma, a subsidiary of BridgeBio Pharma, is a clinical-stage biopharmaceutical company focused on harnessing breakthrough discoveries in our understanding of SHP2 to address the large and growing unmet need in rare and difficult-to-treat cancers. Navire’s team of veteran biotechnology executives are partnering with leading cancer experts to advance effective therapies to patients as rapidly as possible.

BridgeBio finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late-stage development in multiple therapeutic areas, including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company’s focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have offices in San Francisco, Palo Alto, Boston, New York, and Raleigh with small satellites in other parts of the country.

To learn more, visit us at https://navirepharma.com / https://bridgebio.com

Who You Are:

As a Clinical Trial Associate (CTA), you will support the Clinical Operations team members with administrative and project support related to clinical studies. You must have a “can-do” attitude and be open to changes that may occur last minute. You will facilitate the creation of meeting agendas and minutes, track study activities and documents on multiple spreadsheets, assist with reviewing clinical data, and provide full support for the filing and monitoring of the Trial Master File (TMF). 

Responsibilities:

• Maintain study tracking information, including visit reports, patient enrollment, contact list, etc.
• Facilitate the creation of meeting agendas and take meeting minutes for clinical team meetings 
• Assist with the development of tracking tools and processes
• Support study goals by working closely with Clinical Research Associates and Clinical Trial Managers
• Lead document filing, tracking, and maintenance
• Participate in the review of clinical data in the EDC, data listings, and report tables
• Conduct quality review of the TMF and work to resolve discrepancies
• Communicate effectively with internal and external cross-functional team members
• Track laboratory samples and clinical supplies, as needed
• Interact with sites to resolve issues and obtain documents, as required
• Coordinate preparation of study-specific training materials, as required
• Assist with document finalization, including informed consent forms (ICFs), study plans, protocols, and amendments, as required
• Complete other responsibilities as assigned and agreed upon 

Education, Experience & Skills Requirements:

• Bachelor's degree or equivalent training and experience (i.e., technical degree)
• 1-3 years of related experience in clinical operations or health-related industry
• Working experience with an eTMF and clinical trial databases/systems
• Strong attention to detail and excellent organizational skills
• Effective communication, interpersonal skills, and true team player
• Proficient in Microsoft Word, Excel, PowerPoint, and Outlook
• Ability to identify logistical problems and propose solutions 

What We Offer:

• Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to 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
• Learning and development training to help employees be the best version of themselves
• Collaborative business environment
• Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
• Excellent benefits package
• Flexible PTO
• With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
• A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
• Work with the most productive groups of R&D operators in the industry
• Partnerships with leading institutions
• A platform for meaningful scientific contributions to shine
• Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so

We will not accept unsolicited resumes from agencies. Please do not send agency resumes to our website or BridgeBio and affiliating employees.