Remote Senior Clinical Research Associate Oncology Midwest or Southwest

Note: The job is a remote job and is open to candidates in USA. Parexel is a company dedicated to improving the world's health through clinical trials and regulatory consulting. They are seeking a Senior Clinical Research Associate with oncology experience to oversee the delivery of studies at allocated sites, ensuring compliance with regulations and effective collaboration with local study teams.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 trainings appropriately, including ICH-GCP training, prior to and for the duration of the study. Ensures the sites are inspection ready at all timesActively participates in Local Study Team (LST) meetingsContributes to National Investigators meetings, as applicable. Based Quality Management (RBQM) principlesInitiates, monitors and closes study sites in compliance with clients 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 (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 feed-back to the Principal Investigator, including follow-up letter, within required timelines and in line with clients 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, CSP or ICH-GCP compliance issues to Local Management and/or 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 CQADEnsures timely collection/uploading of essential documents into the eTMF in accordance with ICHGCP, clients 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 marketEnsures compliance with clients Code of Ethics, company policies and procedures relating to people, finance, technology, security and SHE (Safety, Health and Environment)Ensures compliance with local, national and regional legislation, as applicableCollaborates with local MSLs as directed by LSAD or line managerSkills5+ years of on site monitoring experience in a CRO or pharma organization1+ years of oncology monitoring experienceBachelor degree in related discipline, preferably in life science, or equivalent qualificationExcellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDPGood knowledge of relevant local regulationsGood medical knowledge and ability to learn relevant client's Therapeutic AreasBasic understanding of the drug development processGood understanding of Clinical Study Management including monitoring, study drug handling and data managementExcellent attention to detailsGood written and verbal communication skillsGood collaboration and interpersonal skillsGood negotiation skillsGood understanding of Clinical Study Management including monitoring, study drug handling and data managementAbility to travel .