Clinical Trial / Clinical Research Associate (CTA or CRA) - Remote in Woburn, Massachusetts at Cytrellis Biosystems Inc

The Clinical Trial Associate (CTA) supports the Clinical Development and Medical Affairs team in the execution of assigned clinical trials, ensuring operational excellence, compliance with ICH-GCP and applicable regulatory requirements, and adherence to study timelines. The CTA contributes across all phases of the clinical trial lifecycle, from study start-up through close-out, and is responsible for the timely execution of study activities and deliverables in alignment with clinical development objectives and corporate goals.

Responsibilities:

Clinical trial activities (60-65%)

• Provide operational support for assigned clinical trial(s) across all phases of the study lifecycle, including start-up, conduct and close-out activities
• Assist Medical Science Liaison (MSL) and other senior team members with day-to-day study activities to ensure study milestones and timelines are achieved
• Track and follow up on study action items through resolution, escalating issues as appropriate
• Develop, maintain and reconcile study trackers including but not limited to protocol deviations, adverse events, site training, enrollment metrics, and key study milestones
• Support data entry, quality and validation activities as required
• Author, format, update, and route study documents, plans, templates and training materials for review and approval
• Review quality check, upload, file, and reconcile documents in accordance with regulatory guidance, and internal SOPs
• Coordinate document review workflows, training distribution, and collection of required documentation from internal teams and sites
• Prepare and maintain study agendas, meeting minutes, action item logs, and study status reports while facilitating effective communication across cross-functional teams and external stakeholders
• Contribute to health authority inspection readiness by providing requested documents
• Ensure study activities are conducted in compliance with ICH-GCP, applicable regulations, study protocols, and internal policies and procedures

Adverse Event and clinical complaint handling (35-40%)

• Review and analyze clinical complaint information and adverse event reporting from clinical trials to determine the depth of investigation required
• Clearly document investigation findings, conclusions and justifications as part of the complaint record in Arena
• Review clinical complaints for Reportability as Adverse Events (Global)
• Provide data for Clinical Complaint Trending

Qualifications:

• Bachelor’s degree in scientific or related field with 2+ years of experience in Clinical Operations, clinical research or healthcare, or equivalent experience
• Working knowledge of the clinical trial lifecycle, from protocol development through study close-out, for aesthetic medical device trials preferred
• Familiarity with ICH-GCP guidelines, clinical trial documents, and applicable regulatory requirements
• Experience with clinical trial systems such as EDC, CTMS and eTMF platforms, preferred
• Proficiency with Microsoft Office applications, including Word, Excel, PowerPoint, and Outlook
• Strong organizational skills with the ability to manage multiple priorities and maintain attention to detail in a fast-paced environment
• Ability to work independently on routine assignments while exercising sound judgment and seeking guidance on more complex issues
• Strong written and verbal communication skills, with demonstrated ability to collaborate effectively within cross-functional teams
• Experience with Smartsheet or similar project management tools is a plus
• Ability to travel as needed