[Remote] Senior Clinical Research Associate - Midwest/Central US - FSP

Note: The job is a remote job and is open to candidates in USA. Parexel is dedicated to improving the world's health through clinical trials and regulatory consulting. The Senior Clinical Research Associate (Sr. CRA) is responsible for site management and monitoring of clinical trials, ensuring patient safety and compliance with regulations. This role involves managing investigator site relationships and overseeing the execution of clinical trials from activation to close-out.ResponsibilitiesEnsure proper conduct of clinical trials in accordance with the Study Monitoring Plan (SMP) and applicable prevailing laws, GCP, and the Sponsor's standards to achieve project goals, timelines and qualityManage 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 metDuring 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 deliveryInterface with the study team as needed, facilitate information flow between members of the study team, vendors and assigned investigator sitesPartner with Site Care Partner 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 risksAttend 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 Site Care Partner and the study team to define and support recruitment initiatives at site levelConduct 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 technologiesMonitor 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 resolutionSubmit 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 metricsIdentify 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 issuesResolve data queries within required timelines, prepare investigator site close-out plan and conduct close-out activities within required timelinesEnsures adequate oversight of the investigational product at the investigator site, including receipt, handling, accounting, storage conditions, and destruction activitiesSupport database release as neededMay undertake the responsibilities of an unblinded monitor where appropriateMaintain thorough understanding of the product, protocol and therapy area in sufficient details to have appropriate discussions with the investigator and site teamInteract with investigator site heath care professionals in a manner which enhances the Sponsor's credibility, scientific leadership and in order to facilitate their clinical development goalsSupport the study clinician in ensuring patient safety, eligibility and providing clinical guidance to investigatorsDrive Quality Event (QE) remediation, when applicableServe as a point of contact for audit conduct, and drive Audit Observation corrective action/preventive action (CAPA) development and checks, when applicableSkillsExtensive knowledge of clinical trial methodologies, ICH/GCP, Food and Drug Administration (FDA) and local country regulationsMonitoring Experience: Minimum 3 years relevant experience in clinical research site monitoring (preferably 2 years in Oncology)Must be fluent in English and in the native language(s) of the country they will work inAbility to travel 60-80%Valid driver's license and passport requiredBachelor's degree in life sciences or professional degree in life sciences such as nursing, pharmacy, medical background or equivalentPreferred therapeutic experience in Oncology, Vaccines, Internal Medicine or Infectious DiseasesCompany OverviewPAREXEL is a biopharmaceutical services company that focuses on the development and commercialization of new medical therapies worldwide. It is a sub-organization of EQT. It was founded in 1983, and is headquartered in Waltham, Massachusetts, USA, with a workforce of 10001+ employees. Its website is http://www.parexel.com.Company H1B SponsorshipParexel has a track record of offering H1B sponsorships, with 14 in 2026, 32 in 2025, 46 in 2024, 41 in 2023, 51 in 2022, 54 in 2021, 33 in 2020. Please note that this does not guarantee sponsorship for this specific role.