Clinical Trial Associate/Senior Clinical Trial Associate

Clinical Trial Associate/Senior Clinical Trial Associate

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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 role

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 
Document & Literature Management
  • Support in locating and providing scientific, clinical, or regulatory literature
  • Respond to documentation requests and assist with document archiving for audits, inspections, and internal reviews
Clinical Data Activities
  • Assist in generating standard outputs and reports and documenting necessary follow-up from electronic Case Report Forms (eCRFs)
  • Support documentation and tracking of ongoing data reviews 
  • Follow up with CROs for monthly protocol deviation (PD) listings and ensure monthly meetings of PD review with leadership and oversight from the CTM 
Contract & Vendor Support
  • Track and manage Confidentiality Agreements (CDAs) and Clinical Trial Agreements (CTAs) in Veeva Vault
  • Maintain and update trackers; coordinate follow-ups with CROs and internal stakeholders
  • Review, track, and file vendor invoices; support invoice-related communication and management 
Investigational Product (IP) & Shipment Monitoring
  • Process internal sign-off cascades for the IMP Release Checklist (GLP Checklist) and maintain filing status trackers
  • Track and follow up with CROs regarding temperature monitoring logs and documentation for drug shipments to clinical sites
Purchasing & Materials
  • Assist in procuring clinical trial-related resources (books, articles, training)
  • Support creation and maintenance of Purchase Orders (POs) in SAP
  • Ensure accurate filing and tracking of vendor invoices
Communication & Site Engagement
  • Support preparation of newsletters and updates for clinical trial sites
  • Create summaries and reports to support trial site engagement and performance tracking
Meetings & Documentation
  • Participate in global clinical project and trial team meetings; prepare meeting minutes when requested
  • Attend internal Clinical Operations meetings and record meeting minutes as needed
SOP & System Access Support
  • Assist in drafting, reviewing, and updating Standard Operating Procedures (SOPs)
  • Submit and track access requests for shared file systems (e.g., SharePoint) on behalf of the Clinical and Translational Science teams

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

Our offer

We offer an exciting opportunity to work with some of the best and brightest in the biotech industry. As part of Merus, you’ll have the chance to collaborate with an exceptional international team of people who are passionate about what they do. To top it off, we offer a highly competitive total rewards package (benefits and compensation), training that is tailored to your individual development, and career opportunities that match your ambitions. Most importantly, you’ll have the chance to join us as we close in on cancer – everything you do matters at Merus.

Apply now

    Our Hiring Process

    Stage 1:

    Internal Review

    This means that we’ve received your application and are in the process of reviewing it.

    Stage 2:

    Initial Call

    We’ll set up a 15-minute phone call with our Internal Recruiter to discuss the details of this job opportunity and your own expectations of the role, as well as Merus as a company.

    Stage 3:

    1st Interview Phase

    During the 1st interview phase, we’ll set up an interview with your potential future manager. We’ll be looking to understand more about your experience, how that fits the role, and what makes you tick.

    Stage 4:

    2nd Interview Phase

    If things are still looking good, we’ll set up several short interviews with team members, peers, Management Team members (where relevant) and HR to make sure we are a good cultural fit. We do our best to plan these interviews on the same day, although on rare occasions they’ll take place on multiple days.

    Stage 5:

    Job Offer

    After positive evaluation from both sides, you will receive our job offer. Once you’ve accepted it, we will draw up the necessary paperwork. You will receive your contract within 3-5 working days and your onboarding process will start!

    Stage 6:

    Welcome

    We’re more than happy to welcome you to join Merus in our pursuit to close in on cancer!

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