Job brief
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
- Manage and maintain Trial Master File (TMF) documents to ensure 100% compliance with ALCOA+ principles and internal quality control standards.
- Coordinate the study start-up process, including the collection and review of regulatory documents such as FDA Form 1572 and financial disclosure forms.
- Track clinical trial performance metrics and site enrollment timelines using Clinical Trial Management Systems (CTMS) to identify and escalate potential delays.
- Participate in site qualification, initiation, and close-out activities to ensure adherence to Good Clinical Practice (GCP) and institutional SOPs.
What is a Clinical Operations Coordinator?
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.
What does a Clinical Operations Coordinator do?
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.
Key responsibilities
- Manage and maintain Trial Master File (TMF) documents to ensure 100% compliance with ALCOA+ principles and internal quality control standards.
- Coordinate the study start-up process, including the collection and review of regulatory documents such as FDA Form 1572 and financial disclosure forms.
- Track clinical trial performance metrics and site enrollment timelines using Clinical Trial Management Systems (CTMS) to identify and escalate potential delays.
- Facilitate regular communication with investigative sites, providing updates on protocol amendments, safety reporting requirements, and ongoing site training needs.
- Prepare comprehensive technical reports and status updates for clinical project managers regarding recruitment status, data query resolutions, and drug supply logistics.
- Participate in site qualification, initiation, and close-out activities to ensure adherence to Good Clinical Practice (GCP) and institutional SOPs.
- Assist in the preparation for internal audits and regulatory inspections by verifying the accuracy and completeness of site-level clinical documentation.
- Collaborate with supply chain teams to track clinical trial material (CTM) shipments, expiry dates, and accountability logs at the site level.
Requirements and skills
- Bachelor’s degree in Life Sciences, Biotechnology, Nursing, or a related healthcare field required.
- Minimum of 2 years of experience in clinical operations, study coordination, or research administration within a CRO or pharmaceutical environment.
- Proficiency in clinical documentation software, specifically Veeva Vault eTMF, Medidata Rave, or similar CTMS platforms.
- Comprehensive knowledge of ICH-GCP guidelines, 21 CFR Part 11, and relevant FDA/EMA regulatory requirements for clinical trials.
- Demonstrated ability to manage high-volume administrative tasks with precision while adhering to strict project timelines and regulatory deadlines.
- Certification such as the Society of Clinical Research Associates (SoCRA) or ACRP-CP is highly preferred for candidates in this role.
- Strong technical writing skills for the development of site manuals, study trackers, and professional correspondence with clinical stakeholders.
- Ability to interpret clinical protocols and communicate complex requirements effectively to non-technical site staff and cross-functional team members.
FAQs
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.