Pharmaceuticals
A Clinical Operations Coordinator supports drug development by managing trial documentation, regulatory compliance, and cross-functional team workflows.
We are looking for a detail-oriented Clinical Operations Coordinator to support our expanding clinical development portfolio and ensure the seamless execution of our phase I-III trials. In this role, you will play a key part in maintaining audit-ready documentation and coordinating directly with research sites and internal stakeholders to drive trial milestones forward. If you are passionate about clinical research excellence, regulatory rigor, and advancing patient health outcomes, we invite you to join our team. We offer a collaborative, science-driven environment where your administrative expertise directly influences the success of life-saving medical innovations.
Key highlights
A Clinical Operations Coordinator is a vital professional who facilitates the efficient execution of clinical research projects and pharmaceutical development pipelines. By managing site documentation, monitoring trial timelines, and ensuring adherence to Good Clinical Practice (GCP), the Clinical Operations Coordinator bridges the gap between research strategy and practical site-level implementation. Their expertise in maintaining regulatory readiness and tracking clinical trial metrics is essential for the timely delivery of safe, evidence-based pharmaceutical products to market.
On a daily basis, a Clinical Operations Coordinator organizes Trial Master File (TMF) documents, coordinates site monitoring visits, and tracks investigator site performance using electronic systems like CTMS or Veeva Vault. They facilitate communication between clinical project managers, investigative sites, and internal departments to resolve study start-up bottlenecks or data query issues. Additionally, they generate progress reports, manage supply logistics for clinical trial materials, and ensure all activities remain fully aligned with FDA or EMA regulatory requirements.
What does a Clinical Operations Coordinator do?
A Clinical Operations Coordinator acts as the administrative and operational backbone of clinical research, ensuring that drug trials run smoothly and according to protocol. Their primary duties include managing the Trial Master File, coordinating with clinical sites, and ensuring that all data collection and storage meet strict regulatory standards like FDA 21 CFR Part 11.
What qualifications are needed to become a Clinical Operations Coordinator?
Candidates typically need a bachelor’s degree in a life science, pharmacy, or nursing field, combined with experience in clinical research or pharmaceutical operations. Proficiency in industry-standard software like CTMS (Clinical Trial Management Systems) or eTMF systems is critical, as is a thorough understanding of ICH-GCP guidelines and pharmaceutical regulatory processes.
How does a Clinical Operations Coordinator interact with clinical research teams?
They serve as a central hub of communication, interacting daily with Clinical Research Associates (CRAs), project managers, site investigators, and regulatory affairs teams. By tracking enrollment progress and site compliance, they ensure that the broader clinical team has the accurate, real-time data needed to make informed decisions about study progress and patient safety.
Why is the Clinical Operations Coordinator role important for drug development?
This role is essential because it ensures that clinical trial data is documented accurately and compliantly, which is the foundation of any successful drug approval. Without diligent coordinators to manage the administrative lifecycle of a trial, researchers would face significant delays, audit failures, or data integrity issues that could stall the development of life-saving therapeutics.