FSP Clinical Trial Coordinator - Site Record Coordination

Accountabilities:: Plan, distribute, collect, and track essential site documentation through Site Collaboration tools, ensuring timely completion and accurate filing within the Trial Master File (TMF). Perform quality control reviews of clinical trial documentation to ensure accuracy, completeness, consistency, and compliance with applicable requirements. Maintain and manage TMF/eTMF, Investigator Site Files (ISF), and other essential study records throughout the clinical trial lifecycle. Support clinical trial management systems, including CTMS, Activate, and eTMF platforms, ensuring that databases, trackers, and study documentation remain accurate and up to date. Coordinate with clinical research sites and internal study teams to facilitate document collection, site start-up activities, feasibility assessments, and regulatory processes. Monitor study documentation progress and operational metrics, identify missing or incomplete records, and follow up on outstanding documentation requirements. Review study performance indicators, resolve documentation-related findings, and communicate site-specific risks, issues, and progress updates to relevant stakeholders. Collaborate with cross-functional teams and external vendors to support site management, regulatory submissions, and clinical trial documentation activities. Facilitate effective communication between investigators, research sites, study teams, and other stakeholders to ensure timely information exchange and resolution of documentation queries. Ensure that all assigned activities comply with ICH-GCP guidelines, internal Standard Operating Procedures (SOPs), Good Documentation Practices (GDP), and applicable regulatory requirements. Support study start-up, ongoing trial conduct, and closeout activities by maintaining complete, organized, and inspection-ready clinical trial records. Requirements: Bachelor's degree preferred in Life Sciences, Pharmacy, Biotechnology, Clinical Research, or a related discipline. 1–3 years of professional experience in Clinical Research, Clinical Operations, TMF/eTMF management, Clinical Trial Coordination, or clinical trial support functions. Hands-on experience supporting global clinical trials and working within international clinical research environments. Practical experience using electronic Trial Master File (eTMF) systems, preferably Veeva. Previous experience managing site-related documentation, Investigator Site Files (ISF), and site collaboration activities. Experience working with international research sites, preferably across Europe and the United States. Good understanding of clinical trial operations, study documentation requirements, and the clinical research lifecycle. Familiarity with clinical trial management systems (CTMS), Activate, eTMF platforms, and other clinical research technologies. Knowledge of ICH-GCP guidelines, Good Documentation Practices, SOPs, and applicable clinical trial regulations. Understanding of regulatory documentation, site start-up requirements, feasibility activities, and essential study records. Strong organizational and administrative skills, with excellent attention to detail and the ability to manage multiple documentation tasks and deadlines. Good analytical and problem-solving abilities, particularly in identifying documentation gaps, tracking outstanding records, and resolving quality findings. Excellent written and verbal communication skills, with the ability to coordinate effectively with research sites, investigators, internal study teams, and external vendors. Proficiency in Microsoft Office applications, particularly Excel, Word, and PowerPoint. Ability to work collaboratively in a cross-functional and international environment while maintaining accuracy, accountability, and compliance. Benefits: Employment type: Full-time position. Work arrangement: Fully remote opportunity based in India. Working schedule: Standard Monday-to-Friday working schedule. Professional development: Opportunity to build expertise in global clinical trial coordination, site management, and clinical documentation. Technical exposure: Hands-on experience with clinical research platforms, including eTMF, CTMS, and site collaboration tools. International experience: Opportunity to collaborate with global clinical research teams and international study sites, particularly across Europe and the United States. Career growth: Develop specialized knowledge in clinical operations, regulatory documentation, and clinical trial quality management. Meaningful contribution: Support clinical research activities that contribute to the development of innovative treatments and improved patient outcomes. Collaborative environment: Work alongside experienced clinical research professionals and cross-functional teams. Compensation and additional benefits: Salary, healthcare coverage, and other employment benefits have not been specifically disclosed and may be discussed during the recruitment process.