Senior Clinical Research Associate - FSP

When our values align, there's no limit to what we can achieve. At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do. Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference. Preferably West/Pacific/West Coast and Central US Positions with Oncology and Non-Oncology Experience Job Description Key Accountabilities:   Oversight 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   Clinical/Scientific and Site Monitoring Risk:   Maintain 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   Collaboration:   Reports 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 requirements  Skills:   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   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 Experience:   Demonstrated 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