Clinical Trial / Clinical Research Associate (CTA or CRA) - Remote

Description

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

Requirements

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