Senior Clinical Research Associate
Bluebird Bio, Cambridge, Massachusetts, United States
integrated product platforms with broad therapeutic potential
ABOUT THE NEST
At bluebird, only two things matter - patients and our people. When you join the nest, you're not just landing a new gig, you become a part of a flock that's soaring to new heights. We’re 1100+ doers, thinkers and collaborators across the globe with a strong sense of our values and our purpose. Our innovation and sustainability are rooted in the diversity of our teams and results are achieved through cooperation and the incorporation of multiple points of view. This is personal and we approach every challenge with radical care. The time is now to rise up and recode the science, the systems, and the status quo.
ABOUT THE FLOCK
Join bluebird bio’s enthusiastic and collaborative Clinical Development Operations (CDO) team by contributing to the overall success of our novel gene therapy approach in beta-thalassemia. Reporting to a Sr. Clinical Trial Manager, the successful candidate will be responsible for supporting multiple studies. This position is a key team member who will effectively organize and assist in the management and close-out of our clinical trials, working closely with internal and external team members around the world.
HOW YOU’LL FLY
As a Clinical Research bird reporting to our Senior Clinical Trial Manager, you'll help to bring more patients their bluebird days by:
- Providing overall program support to the clinical team as well as liaise with other internal and external collaborators to execute on bluebird’s clinical studies
- Assisting with the oversight of vendors including CROs, study vendors and independent contractors; actively participates in revisions to study documents
- Being responsible for oversight and maintenance of Central Files (eTMF), including ensuring files are inspection-ready
- Assisting with review of study specific data in preparation for database lock
- Planning and organizing study related meetings; takes detailed notes at meetings on decisions and action items and distributes the list to the team in the form of minutes
- Understanding the stage of study activities and communicates details to ensure that all team members are kept informed and aware of action items that will impact their tasks. Ensure all study metric trackers, contact lists, checklists and systems are up to date.
- Communicating with CROs and/or CRAs to support accurate completion, retrieval and review of documents in support of regulatory filings
- Assisting in the development of timelines; tracks of details to ensure information is current and timelines are met.
- 10% travel may be required
WHAT YOU’LL BRING
You’re the bird we’re looking for if you:
- Bachelor’s Degree in science or health-related discipline, advanced degree preferred
- Minimum 3 years relevant industry or CRO experience, with site monitoring
- Deep understanding of and experience with electronic TMF, regulatory agency inspection experience preferred
- Proficiency in the entire Windows Suite, including MS-Project
- Solid knowledge of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations is required. A broad understanding of essential study documentation is critical.
All our birds embrace the principles of the bluebird bio culture: b colorful, b cooperative, b yourself.
bluebird bio is deeply committed to fostering an environment where diversity and inclusion are not only valued, but prioritized. We believe a diverse and inclusive community empowers us to act courageously, care deeply, and dream boldly to impact people in big ways. Diverse viewpoints bring diverse capabilities which strengthen our focus and fuel our growth.
bluebird is proud to be an equal opportunity employer, seeking to create a welcoming and diverse environment. All applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status or any other applicable legally protected characteristics.
About Bluebird Bio
About us We are leading the gene therapy revolution. Our integrated product platforms encompass gene therapy, cancer immunotherapy and gene editing – providing us with the potential to treat, and hopefully cure, a broad range of serious diseases. We have a lot of energy, and it’s not just the abundance of coffee that keeps us going. Find out what sparks our excitement and inspires us every day.
Want to learn more about Bluebird Bio? Visit Bluebird Bio's website.
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