DESCRIPTION

The Clinical Trial Assistant (CTA) / Senior CTA plays a vital role in supporting the planning, execution, and documentation of clinical trials in compliance with GCP, ICH, and applicable regulatory standards. The CTA/Sr. CTA is responsible for maintaining essential trial documents, structuring filing systems, managing clinical systems, coordinating with internal teams and CROs, and supporting key operational processes. The Senior CTA will also serve as a mentor, lead onboarding efforts, and help drive continuous process improvements.

YOUR PROFILE

We are looking for a candidate with:

• Bachelor’s degree in Biomedical Sciences, Life Sciences, or a related field
• Strong proficiency in Microsoft Office Suite (Word, Outlook, Excel, PowerPoint)
• Working knowledge of GCP, ICH guidelines, and clinical documentation requirements
• Familiarity with clinical systems including Veeva Vault, eTMF, SAP, and SharePoint is a plus
• Strong attention to detail with excellent organizational skills and the ability to manage multiple priorities
• Clear and professional written and verbal communication skills

In this role you will be responsible for:

• Ensure all tasks comply with Good Clinical Practice (GCP) and regulatory guidelines
• Maintain effective collaboration with internal and external stakeholders
• Structure, manage, Quality Control (QC) review and provide detailed oversight of Merus’s clinical trial document filing system (eTMF and/or physical) including follow-up on metrics and remediation of any noted deficiencies from internal and external review processes
• File and (QC) essential clinical trial documents for assigned trials
• Instruct and support CTAs on QC and filing procedures (Sr. CTA responsibility)
• Maintain and monitor access to Microsoft TEAMS channels, share point sites, and any relevant clinical systems, trackers, training tools etc. for both internal and external members; regularly review access permissions and content
• Coordinate and schedule meetings including room reservations and dial-in/virtual access details, as well as provide detailed minutes and finalized agendas for multiple meetings
• Lead onboarding for Clinical Operations project staff, including system access requests and GCP and study training setup
• Initiate monthly project compliance dashboard updates for assigned studies and work to finalize updates with oversight from the Clinical Trial Manager (CTM) and / or Project Director (PD)
• Initiate requests and track project Confidentiality Disclosure Agreements (CDAs), Clinical Trial Agreements (CTAs) and Purchase Orders (PO) for assigned project
• Maintain Clinical Trial Trip Report Review Tracker in collaboration with the CTM assigned to review reports. Initiate follow-up with Clinical Research Organization (CRO) on remediation of findings.
• Completion of ClinicalTrials.Gov postings as necessary according to processes, with detailed oversight from CTM / Project Director assigned
• Maintenance of an actions decisions log (ADI log) for assigned project covering all internal meetings and provision of follow-up of remediations with CTM oversight