Senior Clinical Research Associate I - FSP

Key AccountabilitiesOversight of Monitoring Responsibilities and Study Conduct :Ensure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and client standards to achieve project goals, timelines and quality  Manage assigned 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  During study conduct, serve as the primary point of contact for assigned investigator sites.  Work in partnership with and/or escalate 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 SCP to perform investigator site development, coaching and training of site personnel to ensure ongoing compliance with protocol and the safeguarding of patients; provide protocol training to, and address protocol related questions from the investigator site staff when required, including discussions on known/anticipated operational and clinical trial risks  Attend investigator meeting when required (virtual or F2F).  Provide enrollment support and ensure progress by responding to site activation and recruitment issues from investigators.  Partner with SCP 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 and ensure these are conducted accordance to the SMP, Standard Operating Procedures (SOPs) and commensurate with 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 required information 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 to 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  Ensures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activities  Support database release as needed  May undertake the responsibilities of an unblinded monitor where appropriate  Clinical/Scientific And Site Monitoring RiskMaintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site team  Interact with investigator site heath care professionals in a manner which enhances the client’s credibility, scientific leadership and in order to facilitate the client’s 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  CollaborationReports to Director of Clinical Site Operations (DCSO) or Director of Site Management and Monitoring (DSMM)  Partners with SCP and Country Study Operations Manager (SOM)  When required Partners with other Study Team members (e.g. Clinician, Recruitment Specialist, Clinical Data Scientist)  May act as a Mentor for Clinical Research Associates  Compliance With Parexel Standards Complies with required training curriculum Completes timesheets accurately as required Submits expense reports as required. Updates Curriculum Vitae (CV) as required Maintains a working knowledge of and complies with Parexel processes, ICH-GCPs and other applicable requirementsSkillsExtensive 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  Global clinical trial experience  Must be fluent in English and in the native language(s) of the country they will work in   Significant travel (60-80%) within area is required.  May require some international travel and some weekend travel  Valid driver’s license and passport required  Knowledge And ExperienceDemonstrated knowledge of clinical research and development processes and ability to gain command of process details  Demonstrated knowledge of global and local regulatory requirements  Demonstrated understanding of key operational elements of clinical research (e.g., monitoring, data acquisition and cleaning, reporting, etc.)  Demonstrated knowledge in disease and technical areas pertaining to clinical studies, including knowledge of company direction, investigational product(s), and associated development plan(s)  Demonstrated ability to support sponsor regulatory interactions/inspections  Demonstrated knowledge of the processes around protocol design and feasibility assessment  Demonstrated understanding of region/country, culture, and medical practice and how they affect clinical trial delivery  Proven ability to work in a matrix team environment with the ability to influence, drive / lead and work through others for successful delivery of clinical trial  Ability to evaluate, interpret and present complex issues and data to support risk management and mitigation  Effective verbal and written communication skills in relating to colleagues and associates both inside and outside of the organization  EducationBachelor’s degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalent