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SalaryPhiladelphia, PA
Cabaletta Bio (Nasdaq: CABA) is a clinical-stage biotechnology company focused on developing and launching targeted, potentially curative, cellular therapies for patients with autoimmune diseases. The CABA™ platform includes two strategies to treat and potentially cure many of the most common and challenging autoimmune diseases. The CARTA strategy, or Chimeric Antigen Receptor T cells for Autoimmunity, is designed to potentially reset the immune system by causing transient B cell depletion with early academic clinical data suggesting the potential of this strategy to transform treatment in patients with SLE and the possibility of cures in rheumatoid arthritis, myositis, and systemic sclerosis, among others. Our lead product candidate using the CARTA strategy is CABA-201, 4-1BB-containing CD19-CAR T designed specifically to treat patients with autoimmune diseases with high unmet need, including systemic lupus erythematosus (SLE), myositis, systemic sclerosis, and generalized myasthenia gravis, and which uses a CD-19 binder that has an encouraging clinical tolerability profile. In addition to our CARTA candidate, CABA-201, we have a clinical-stage pipeline of Chimeric AutoAntibody Receptor T (CAART) cells targeted to the cells responsible for autoantibody-mediated autoimmune diseases. Cabaletta Bio’s headquarters are located in Philadelphia, PA. For more information, visit www.cabalettabio.com and follow us on LinkedIn and X (Twitter).
Uniquely Differentiated. Rapid. Elegant.
At Cabaletta, we are driven by the shared mission of developing cures, where a patients’ own cells are used to fight disease. We are building a culture grounded in the knowledge that successful cures can be achieved for patients if every member of the Cabaletta is focused on the success of the team. To nurture this, we make an active commitment to the well-being and continuous growth of each employee who joins the team. In this way, we are not only working to improve the lives of patients, but of everyone involved. #CabalettaCrew.
We’re proud to be a Great Place to Work-Certified™ company! #GPTWcertified Check out what our employees say makes working here so great: Working at Cabaletta Bio Inc | Great Place to Work®
About the Position
Reporting to the Senior Manager, Clinical Operations, the In-House Clinical Research Associate (CRA) is responsible for supporting the planning, execution, and management of clinical trials from within the sponsor company. They work closely with the study team, including the Clinical Project Manager, Clinical Trial Manager, and other members of the Clinical Operations team. This is a remote position.
Responsibilities:
- Provide monitoring oversight by reviewing monitoring reports and escalate any trends with respect to data quality or study conduct to the appropriate CTM, Clinical Operations.
- Perform Clinical Research site activities, such as onsite or remote co-monitoring, training, motivational, and sponsor oversight visits, as needed.
- Support the oversight of activities of CRO and study vendors to ensure compliance with the study protocol and on-time achievement of overall clinical objectives and deliverables.
- Contribute to the development of study documentation including protocol review, creating study manuals, ICFs, study plans and CRFs. Contribute to study start-up activities including site selection.
- Support the Clinical Operations team and cross-functional representatives as required in relationship management tasks (e.g., study logistics, patient enrollment, safety, data management, etc.) to accurately coordinate clinical study activities.
- Ensure that study documentation is maintained according to applicable regulations, industry accepted standards, and SOPs that govern clinical studies.
- Collaborate with Clinical, Regulatory, and Quality team members to ensure compliance of study activities.
- Identify and resolve study-related issues and deviations.
- Communicate with study sites and investigators.
- Provide support to study sites, including training and troubleshooting.
- Support various administrative tasks for the Clinical Operations team including scheduling meetings and taking minutes.
- Perform other duties and assignments as required for the overall success of the projects.
Qualifications:
- A bachelor's or master's degree in a relevant field, such as life sciences, nursing, or pharmacy.
- At least 2-3 years of experience in Clinical Research, preferably in a CRA or related role.
- Experience with all aspects of trial and site set up and vendor selection and management, study management, and monitoring.
- Strong knowledge of clinical trial conduct, GCP, FDA regulations, and ICH guidelines.
- Excellent written and verbal communication skills to effectively communicate with study sites, investigators, and internal study team members.
- Strong organizational skills to manage multiple tasks and priorities simultaneously.
- Strong attention to detail to ensure accurate and complete data collection and documentation.
- Proficiency in Microsoft Office applications and experience working with electronic data capture systems (EDC).
- Ability to build positive relationships with study sites and investigators.
- Flexibility to adapt to changing project needs and timelines.
- Strong team orientation and passion for continuous self-development.
- Ability to travel up to 20%.
- Strong team orientation and passion for continuous self-development.
- Experience in industry or in a startup industrial setting is preferred.
Our name – Cabaletta – is derived from the operatic term that represents a rapid, repetitive, and technically challenging section of an operatic aria, designed to showcase the skills of the lead singer. Analogously, Cabaletta Bio strives to achieve rapid and repetitive product development, building on our indication prioritization and biologic platform that targets the driver of specific autoimmune diseases without the need for long-term immunosuppression.
For more information, please visit https://www.cabalettabio.com/join-our-crew
Our most important asset is our people, and we offer competitive benefits, PTO, and stock option plans.
Cabaletta Bio is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law.
Cabaletta Bio, Inc. does not accept unsolicited resumes from recruiters, employment agencies, or staffing firms. To conduct business with Cabaletta, a Master Services Agreement (MSA) must be executed and confirmed prior to submitting any information relating to a potential candidate. Without a signed MSA, Cabaletta shall not be responsible to any individual or entity for any payment relating to any form of fee or compensation.
And, if a resume or candidate is submitted by a recruiter, an employment agency, or a staffing firm without a fully executed MSA, Cabaletta has the unrestricted right to pursue and hire any of those candidate(s) without any legal or financial responsibility to the recruiter, agency, and/or firm.
