Senior Clinical Research Coordinator

Leads Clinical Research Activities

The Senior Clinical Research Associate is responsible for the management and monitoring of clinical trials at investigator sites to ensure quality study execution in accordance with applicable laws, Good Clinical Practices (GCP), and industry standards.

• Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable laws, GCP, and industry standards to achieve project goals, timelines, and quality.
• Manage operational aspects for implementation of clinical trial activities at assigned investigator sites from site activation through to database lock, ensuring relevant timelines and quality deliverables are met.
• Serve as the primary point of contact for assigned investigator sites, working in partnership with and/or escalating to the SCP to ensure quality of site delivery.
• Interface with the study team as needed, facilitate information flow between members of the study team, vendors, and assigned investigator sites.
• Partner with Site Care Partner to perform investigator site development, coaching, and training of site personnel to ensure ongoing compliance with protocol and patient safety.
• Attend investigator meetings when required. Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators. Partner with Site Care Partner and the study team to define and support recruitment initiatives at site level.
• Conduct onsite, remote/electronic monitoring as needed for study site initiation, routine monitoring, and study site closure activities, ensuring these are conducted in accordance with the SMP, Standard Operating Procedures (SOPs), and emerging issues and technologies.
• Monitor site-level adverse events (AEs) and serious adverse events (SAEs) and collaborate with the Drug Safety Unit, following up with investigator sites as needed, to bring SAE reports to resolution.
• Submit all required reports, documentation, updates, and tracking within required timeframes, including Trial Master File (TMF) documentation, site reports, site follow-up letters, protocol deviations, patient recruitment, clinical supply management, study progress, and metrics.
• Identify and resolve investigator site issues within required timeframes; agree and develop corrective and preventative actions with investigators and site personnel to close open issues and prevent recurrence/persistence of issues.
• Resolve data queries within required timelines, prepare investigator site close-out plans, and conduct close-out activities within required timelines.
• Ensure adequate oversight of investigational products at investigator sites, including receipt, handling, accounting, storage conditions, and destruction activities.
• Support database release as needed.
• May undertake responsibilities of an unblinded monitor where appropriate.Clinical/Scientific and Site Monitoring Risk:
  • Maintain a thorough understanding of products, protocols, and therapy areas in sufficient detail to have appropriate discussions with investigators and site teams.
  • Interact with investigator site healthcare professionals in a manner that enhances the Sponsor's credibility, scientific leadership, and facilitates clinical development goals.
  • Support the study clinician in ensuring patient safety, eligibility, and providing clinical guidance to investigators.
  • Drive Quality Event remediation, when applicable.
  • Serve as a point of contact for audit conduct and drive Audit Observation CAPA development and checks, when applicable.
  Requirements:
  • Extensive knowledge of clinical trial methodologies, ICH/GCP, FDA, and local country regulations.
  • Monitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology).
  • Preferred therapeutic experience in Oncology, Vaccines, Internal Medicine, or Infectious Diseases.
  • Must be fluent in English and in the native language(s) of the country they will work in.
  • Ability to travel 60-80%.
  • Valid driver's license and passport required.