Clinical Trial Associate (Hybrid)

About the role

The Clinical Trial Associate plays a key role in the successful execution of global clinical investigations by supporting the logistics and operational aspects of clinical studies. Working as part of the global Clinical Affairs and Clinical Operations teams, this role collaborates closely with Clinical Operations Managers, Clinical Project Managers, and other study staff to ensure that studies run efficiently, documentation remains inspection-ready, and timelines are met. The Clinical Trial Associate works with a high degree of autonomy, proactively drives processes forward, and serves as a reliable operational partner to the broader study team.

Responsibilities

• Set up electronic Trial Master Files (eTMF) and maintain in-house filing of Trial Master File documents in accordance with standard operating procedures and good clinical practice guidelines (including ISO standards).
• Support ongoing use of clinical trial management systems (CTMS) by maintaining and tracking study contacts and relevant activities.
• Support study start-up and site selection processes, including preparation and follow-up of confidentiality agreements, retrieval of completed site selection questionnaires, and maintenance of site selection trackers.
• Coordinate translations of study documents to support global clinical investigations.
• Assist in preparing submission packages for Ethics Committees, Institutional Review Boards (IRBs), and Competent Authorities, including pulling outcome documents from IRB systems where applicable.
• Prepare documentation for Site Initiation Visits by creating site-specific documents and compiling Investigator Site Files, or overseeing external suppliers responsible for these materials.
• Under general supervision, ensure timely filing and tracking of study essential documents and maintain the quality and completeness of the Trial Master File to ensure audit and inspection readiness at all times.
• Perform quality control checks of uploaded data and documentation in relevant systems.
• Assist in the preparation for and provide support during audits and inspections related to clinical studies.
• Manage logistics for study-related supplies and services (excluding non-investigational devices), including coordination of study material shipments to clinical study sites.
• Support the study team in general conduct activities, such as organizing meetings, preparing newsletters and presentations, coordinating mailings to sites, and managing general correspondence.
• Review and update dashboards and tracking tools to provide accurate visibility into study status and key activities.
• Maintain site and sponsor contact information in CTMS for each study, including start and stop dates, and send regular updates to sites as needed.
• Maintain study-specific training matrices to track required and completed training for study personnel.
• Track study insurance coverage and maintain associated documentation.
• Track study agreements and contracts to ensure timely execution and ongoing compliance.
• Support the set-up of dedicated payment systems (within CTMS or external tools) for study-related payments.
• Prepare, track, and process study site invoices, maintain payment overviews, and support accruals, tracking, and maintenance of purchase orders.
• Support quarterly HCO/HCP Sunshine Reporting for applicable US-based activities.
• Participate in internal project meetings, taking notes and documenting action items to ensure follow-up and accountability.
• Support and follow up on local team meetings and local investigator meetings, including managing attendee lists, agendas, meeting materials, and meeting minutes where applicable.
• Support study and site close-out activities, including invoice reconciliation and coordination of device and supply returns.
• Support the team with system uploads and follow-up activities related to engagement and contract management tools.
• Support Study Start-Up (SSU) activities, including essential document collection, review, and coordination of site activation steps.
• Manage site agreements and site selection activities in close collaboration with clinical project management.
• Coordinate IRB submissions and track approvals to ensure sites remain compliant and authorized to conduct study activities.
• Prepare documentation for Site Initiation Visits (SIVs) and Site Monitoring Visits (SMVs), ensuring all materials are accurate and complete.
• Oversee documentation uploaded into the Trial Master File, ensuring accuracy, completeness, and alignment with regulatory expectations.
• Support oversight of clinical supply shipments, including coordination of label setup performed internally and collaboration with teams responsible for shipping logistics.
• Support FDA-related filings and systems as needed for clinical studies.
• Actively learn and own operational processes, drive work forward independently, and serve as a solution-oriented partner who reduces workload for the broader team rather than creating additional work.

Requirements & Qualifications

Essential Skills:

• Minimum of 4+ years of prior work experience as a Clinical Research Associate or in a comparable position supporting or assisting clinical project management within a medical device company, pharmaceutical company, or contract research organization.
• Clinical research experience, including hands-on involvement in clinical trials or clinical investigations.
• Experience supporting study start-up and site management activities.
• Familiarity with FDA filing systems and regulatory documentation.
• Knowledge of international regulations and guidelines such as ISO 14155 and Good Clinical Practice (GCP), as well as clinical study design and implementation.
• Strong organizational and document management skills with proven ability to maintain inspection-ready files.
• Working knowledge of medical terminology relevant to clinical research.
• Ability and willingness to learn device function and understand how it relates to clinical use.
• Capability to interface effectively and professionally with medical professionals and site staff.
• Strong analytical and organizational skills with excellent attention to detail and accuracy.
• Demonstrated project oversight and tracking capability, including use of trackers and dashboards.
• Good oral and written communication skills, especially in email and virtual collaboration tools.
• Ability to work autonomously with excellent organizational skills and the ability to prioritize assignments while handling multiple projects simultaneously.
• Experience with electronic data capture systems and clinical trial management systems (CTMS).
• Demonstrated ability to perform effectively in a team environment and build strong working relationships.
• Fluency in English, both written and