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SalaryAbout 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 Include
- 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.
Required 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.
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How to Apply
Please click the link at the bottom of the posting to submit an application.
Benefits
Our most important asset is our people and we offer competitive benefits including health and retirement, PTO, and stock option plans.
Equal Opportunity Employer
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.
