Senior Clinical Trial Associate

Location
Brisbane, California
Posted
Jul 21, 2021
Hotbed
Biotech Bay
Required Education
Associate Degree
Position Type
Full time
QED Therapeutics, a subsidiary of BridgeBio Services, focuses on precision medicine for FGFR-driven cancers and diseases. The company’s first therapy, TRUSELTIQTM (infigratinib), is an orally administered FGFR1-3 tyrosine kinase inhibitor that the US FDA recently approved for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma (CCA) harboring an FGFR2 fusion or rearrangement. We are also evaluating infigratinib for the treatment of other FGFR-driven cancers as well as for the treatment of achondroplasia and other skeletal dysplasias. 

QED is derived from the Latin “Quod Erat Demonstrandum” —Thus; It Has Been Proven. 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 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://www.qedtx.com/ | https://bridgebio.com 

Who You Are:

As a Senior Clinical Trial Associate (Sr. 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 last minute.  You will facilitate the creation of meeting agendas and minutes, track study activities and documents on multiple spreadsheets, assist with review of clinical data, monitoring report review, 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
  • Participate in the review of monitoring reports and tracking of report review
  • 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:
  • Bachelors degree or equivalent training and experience (i.e., technical degree)
  • Minimum of 4 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


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.