Clinical Trial Coordinator II - FSP

Accountabilities

• • Coordinate assigned clinical trial activities in line with established task matrices, project plans, timelines, quality standards, and applicable procedures.
  • Perform departmental, internal, country, investigator, and study file reviews, documenting findings accurately in the appropriate systems and supporting audit readiness.
  • Manage clinical trial documentation, including timely processing of documents to electronic Trial Master Files, eTMF reviews, mass communications, reports, and study-specific materials.
  • Review and track local regulatory documentation, reconcile study metrics and findings, and support resolution of documentation-related issues.
  • Maintain vendor trackers and provide administrative and technical support to project teams and internal stakeholders.
  • Support the preparation, coordination, compilation, and distribution of Investigator Site File and Pharmacy Binder materials, translations, and non-clinical study supplies.
  • Maintain accurate study status information, team lists, training requirements, system access records, activity plans, and other project-level trackers.
  • Provide support for clinical trial systems such as eTMF and CTMS, including document transmission, system updates, and related administrative activities.
  • Support site activation and start-up activities by coordinating with internal teams, aligning activities with critical-path timelines, and assisting with regulatory submission packages.
  • Assist with site feasibility activities, including developing site lists, researching internal and external sources, contacting investigators and site personnel, collecting site-interest information, and maintaining accurate contact details.
  • Support the evaluation of feasibility survey data, ensuring responses are complete, logical, and aligned with the questions asked.
  • Develop and maintain effective relationships with investigators, site personnel, client affiliates, and internal clinical teams as required.
  • Conduct or support site contact activities, including phone interviews with physicians and site personnel, to gather information relevant to trial feasibility and optimization.
  • Collaborate with Global Investigator Services and other stakeholders to resolve investigator queries and maintain accurate account and contact information.
  • Monitor assigned activities against timelines, identify risks or deviations, and escalate concerns appropriately to project leads and management.
  • Support risk-based monitoring activities, kick-off meetings, meeting scheduling, meeting minutes, and other project coordination needs.
  • Contribute to the development and implementation of global feasibility processes, operational best practices, and process improvements.
  • Train or support the onboarding of new team members and share knowledge of relevant systems, processes, and clinical trial procedures.

  Requirements

  • Bachelor’s degree preferred, ideally supported by relevant experience in clinical research, life sciences, healthcare, or a related discipline.
  • At least 2 years of relevant experience in a Clinical Trial Coordinator or comparable clinical operations role.
  • Hands-on experience with Veeva eTMF and CTMS is required.
  • Previous experience supporting global clinical trials and coordinating effectively with local and international project team members.
  • Experience with vendor management is preferred.
  • Working knowledge of clinical trial processes, applicable country regulations, ICH Good Clinical Practice (GCP), and relevant SOPs and work practice documents.
  • Understanding of clinical documentation, investigator/site management, study start-up, regulatory requirements, and clinical trial systems.
  • Basic knowledge of medical terminology, therapeutic areas, and local healthcare systems.
  • Strong organizational and planning skills, with exceptional attention to detail and the ability to manage multiple activities simultaneously.
  • Ability to analyze project data and clinical trial systems to identify discrepancies, maintain accuracy, and support efficient project delivery.
  • Excellent written and verbal communication skills, including the ability to communicate effectively with medical professionals, investigators, site personnel, and internal stakeholders.
  • Strong English language and grammar skills, together with proficiency in the relevant local language.
  • Strong customer focus, interpersonal skills, presentation abilities, and relationship-building capabilities.
  • Ability to work independently while also collaborating effectively within a matrixed, global team environment.
  • Self-motivated, adaptable, and comfortable reprioritizing work in response to changing project timelines and priorities.
  • Strong problem-solving skills, independent thinking, and the ability to identify, manage, and appropriately escalate risks.
  • Good negotiation and stakeholder-management skills.
  • Proficiency in Microsoft Office, including Word, Excel, and PowerPoint, with the ability to learn and use clinical trial databases and specialized software.
  • Willingness and ability to successfully complete required clinical training programs.
  • Ability to occasionally travel to clinical sites or other locations when required.

  Benefits

  • Fully remote: Work remotely from India in a global clinical research environment.
  • Full-time position: Standard Monday-to-Friday work schedule.
  • Global exposure: Collaborate with international clinical operations teams, investigators, sites, vendors, and project stakeholders.
  • Professional development: Opportunity to strengthen expertise across clinical trial coordination, site activation, feasibility, documentation, and regulatory processes.
  • Learning opportunities: Exposure to clinical trial technologies, systems, processes, and evolving industry best practices.
  • Career growth: Opportunities to take on additional responsibilities, support new team members, and contribute to process improvement initiatives.
  • Collaborative environment: Work within a structured, cross-functional and globally connected clinical operations organization.
  • Purpose-driven work: Contribute to clinical research programs that support the development of therapies and healthcare solutions.
  • Flexibility: Home-office environment with occasional travel or site visits where required.