Clinical Research Professional

Senior Clinical Research Associates are responsible for ensuring the quality of clinical trials at investigator sites. They oversee site management, monitoring, and close-out activities to guarantee patient safety and study execution in accordance with prevailing laws, Good Clinical Practices (GCP), and sponsor standards.

• Ensure proper conduct of clinical trials according to the Study Monitoring Plan (SMP) and applicable laws, GCP, and sponsor 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 database lock, ensuring relevant timelines and quality deliverables are met.
• Serve as primary point of contact for assigned investigator sites and work in partnership with Site Care Partner to ensure quality of site delivery.
• Interface with study team members, vendors, and investigator sites to facilitate information flow and resolve issues.
• 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 and provide enrollment support to ensure progress by responding to site activation and recruitment issues from investigators.
• Conduct onsite, remote, or electronic monitoring as needed for study site initiation, routine monitoring, and study site closure activities and ensure these are conducted according to 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 and follow-up with investigators sites, as needed, to bring SAE reports to resolution.
• Submit all required reports, documentation, updates, and tracking within required timeframes, including but not limited to 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 investigator and site personnel to close open issues and prevent recurrence/persistence of issues.
• Resolve data queries within required timelines, prepare investigator site close-out plan, and conduct close-out activities within required timelines.
• Ensure adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities.
• Support database release as needed.

• Maintain a thorough understanding of the product, protocol, and therapy area in sufficient detail to have appropriate discussions with the investigator and site team.
• Interact with investigator site healthcare professionals in a manner that enhances the Sponsor's credibility, scientific leadership, and facilitates their clinical development goals.
• Support the study clinician in ensuring patient safety, eligibility, and providing clinical guidance to investigators.
• Drive Quality Event (QE) remediation, when applicable.
• Serve as a point of contact for audit conduct and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicable.

• Extensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (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.

• Bachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background, or equivalent.