[Remote] Senior Clinical Research Associate - Oncology - FSP

Note: The job is a remote job and is open to candidates in USA. Parexel is dedicated to improving global health through clinical trials and regulatory consulting. The Senior Clinical Research Associate (SrCRA) is responsible for managing study sites, ensuring compliance with regulations, and collaborating with local study teams to achieve study goals efficiently. This role requires a proactive approach to site management and the ability to mentor junior staff.ResponsibilitiesContributes to the selection of potential investigatorsIn some countries, as required, SrCRAs are accountable for study start-up and regulatory maintenance. Tasks may include Site Qualification Visits, collection, preparation, review and tracking of documents for the application process; submission of proper application/documents to EC/IRB and to Regulatory Authorities for start-up and for the duration of the studyTrains, supports, and advises Investigators and site staff in study related matters, including Risk Based Quality Management (RbQM) principlesConfirms that site staff have completed and documented the required training appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are always inspection readyActively participates in Local Study Team (LST) meetingsContributes to National Investigators meetings, as applicableInitiates, monitors, and closes study sites in compliance with Client Procedural Documents. Shares information on patient recruitment and study site progress (site quality/performance) within the LSTDrives performance at the sites. Proactively identifies and ensures timely resolution to study-related issues and escalates them as appropriateUpdates CTMS and other systems with data from study sites as per required timelinesManages study supplies (Investigator Site File (ISF), etc.), drug supplies and drug accountability at study site. Prepares study drug for destruction, if applicablePerforms monitoring visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study specific Monitoring Plan. If required, determines and discusses with LSAD the correct timing and type of visitsPerforms Source Data Review (SDR), Case Report Form (CRF) review and Source Data Verification (SDV), in accordance with the Monitoring PlanPerforms regular Site Quality Risk Assessments and adapts monitoring intensity accordingly during the studyEnsures data query resolution in a timely mannerWorks with data management to ensure robust quality of the collected study dataEnsures accurate and timely reporting of Serious Adverse Events and their follow upsPrepares and finalizes monitoring visit reports in CTMS and provides timely feedback to the Principal Investigator, including follow-up letter, within required timelines and in line with Client SOPFollows up on outstanding actions with study sites to ensure resolution in a timely mannerFollows quality issue processes by escalating systematic or serious quality issues, data privacy breaches, Clinical Study Protocol (CSP) or ICH-GCP compliance issues to Local Management and/or Clinical Quality Management (CQM) as requiredAssists site in maintaining inspection ready ISFPrepares for and collaborates with the activities associated with audits and regulatory inspections in liaison with LSAD and Clinical Quality Associate Director (CQAD)Ensures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, Client SOPs and local requirements. Supports/participates in regular QC checks performed by LSAD or delegateEnsures that all study documents under their responsibility (i.e., site documents, relevant communications, etc.) are available and ready for final archiving and completion of local part of the eTMFProvides feedback on any research related information including sites/investigators/competing studies that might be useful for the local marketCollaborates with local Medical Scientific Liaisons (MSLs) as directed by LSAD or line managerSkills5+ years of direct Monitoring / CRA experience in a CRO or Pharma organization2+ years direct Oncology Monitoring / CRA experience in a CRO or Pharma organizationFamiliar with risk-based monitoring approach including remote monitoringGood cultural awarenessBachelor's degree requiredExcellent attention to detailGood written and verbal communication skillsGood collaboration and interpersonal skillsGood negotiation skillsProficient in written and spoken English language requiredFluency in local language(s) requiredAbility to work in an environment of remote collaboratorsAbility to look for and champion more efficient and effective methods/processes of delivering quality clinical trials with reduced budget and in less timeGood analytical and problem-solving skillsDemonstrates ability to prioritize and manage multiple tasks with conflicting deadlinesAbility to understand the impact of technology on projects and to use and develop computer skills while making appropriate use of systems/software in an e-enabled environmentTeam oriented and flexible; ability to respond quickly to shifting demands and opportunitiesExcellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDPGood knowledge of relevant local regulationsGood medical knowledge and ability to learn relevant Client Therapeutic AreasBasic understanding of the drug development processGood understanding of Clinical Study Management including monitoring, study drug handling and data managementCompany 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.