Clinical Trial Associate/Senior Clinical Trial Associate

Clinical Trial Associate/Senior Clinical Trial AssociateDepartment: Clinical OperationsEmployment Type: Full TimeLocation: Cambridge, MADescriptionThe 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 roleIn this role you will be responsible for: Ensure all tasks comply with Good Clinical Practice (GCP) and regulatory guidelinesMaintain effective collaboration with internal and external stakeholdersStructure, 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 trialsInstruct 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 contentCoordinate and schedule meetings including room reservations and dial-in/virtual access details, as well as provide detailed minutes and finalized agendas for multiple meetingsLead onboarding for Clinical Operations project staff, including system access requests and GCP and study training setupInitiate 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 ManagementSupport in locating and providing scientific, clinical, or regulatory literatureRespond to documentation requests and assist with document archiving for audits, inspections, and internal reviewsClinical Data ActivitiesAssist 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 SupportTrack and manage Confidentiality Agreements (CDAs) and Clinical Trial Agreements (CTAs) in Veeva VaultMaintain and update trackers; coordinate follow-ups with CROs and internal stakeholdersReview, track, and file vendor invoices; support invoice-related communication and management Investigational Product (IP) & Shipment MonitoringProcess internal sign-off cascades for the IMP Release Checklist (GLP Checklist) and maintain filing status trackersTrack and follow up with CROs regarding temperature monitoring logs and documentation for drug shipments to clinical sitesPurchasing & MaterialsAssist in procuring clinical trial-related resources (books, articles, training)Support creation and maintenance of Purchase Orders (POs) in SAPEnsure accurate filing and tracking of vendor invoicesCommunication & Site EngagementSupport preparation of newsletters and updates for clinical trial sitesCreate summaries and reports to support trial site engagement and performance trackingMeetings & DocumentationParticipate in global clinical project and trial team meetings; prepare meeting minutes when requestedAttend internal Clinical Operations meetings and record meeting minutes as neededSOP & System Access SupportAssist 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 teamsYour profileWe are looking for a candidate with:Bachelor's degree in Biomedical Sciences, Life Sciences, or a related fieldStrong proficiency in Microsoft Office Suite (Word, Outlook, Excel, PowerPoint)Working knowledge of GCP, ICH guidelines, and clinical documentation requirementsFamiliarity with clinical systems including Veeva Vault, eTMF, SAP, and SharePoint is a plusStrong attention to detail with excellent organizational skills and the ability to manage multiple prioritiesClear and professional written and verbal communication skillsOur offerWe 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.