BridgeBio
Description
Navire Pharma, an affiliate 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 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.
As a Clinical Trial Associate (CTA), you will support 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 at the last minute. You will facilitate the creation of meeting agendas and minutes, track study activities and documents on multiple spreadsheets, assist with the review of clinical data, and provide full support for the filing and monitoring 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 a 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.
Educations, Experience and Skills Requirement
- Bachelor's degree or equivalent training and experience (i.e., technical degree).
- Minimum of 3-5 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.
- Able to identify logistical problems and propose solutions.
