Senior Clinical Research Associate

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: The Senior CRA executes clinical trial protocols at clinical trial sites and monitors clinical trials in accordance to ICH guidelines and GCP, local regulations, and applicable SOPs. Performs monitoring activities related to initiation, conduct (recruitment, quality data collection) and timely completion of Oncology and Pharma clinical trials within the assigned region. The Senior CRA is responsible for performing quality oversight site visits and collaborating closely with the Clinical Operations Study Lead to ensure study timelines are adhered to and required quality standards are maintained, mentor and manage CRAs. Essential Functions of the job: The following functions may apply based on study and program requirements;Mentor and manage junior staff and Clinical Research AssociatesActs as the escalation point person for CRA(s) with site related issues and concernsReview RFPs and SOWs to ensure adequate CRO monitoring and relevant CRO procedures are correctly reflectedConducts monitoring (pre-study, initiation, routine monitoring and closeout visit) per monitoring plan and applicable SOPsConducts co-monitoring visits, if requiredConducts Quality Oversight Visits (QOV) or other monitoring visits, as requestedCompletes monitoring visit/ QOV reports timelyDocuments monitoring activities appropriately following ICH-GCP and BeiGene standardsAssists with investigator/site identificationProvides protocol and related study training to assigned sitesManages site performance by tracking regulatory submissions, recruitment, case report form (CRF) completion, and data query resolutionCollaborates with Clinical Operations Study Lead and clinical study sites to ensure timely delivery of study milestones (i.e., study startup, recruitment, database analyses, closeout, etc.)Supports the Clinical Operations Study lead to manage the clinical study sites, as requiredEstablish regular lines of communication with sites and reports site progress and issues to Clinical OperationsSupport with study plans, development of presentations to support milestones and related key findingsAuthors or reviews monitoring plan and recruitment planHelps to develop and reviews site specific recruitment materials and toolsAttends disease indication project specific training and general CRA training as requiredFacilitate site audits and/or inspectionsEvaluates the quality and integrity of site practices – escalating quality and/or GCP issues with Investigators and internal team as appropriateAttends regional investigator meeting and site booster visits, as requiredPerform and support as needed the Clinical Study Lead with clinical data review of listings for completeness during key submission timesSupervisory Responsibilities: Provide mentoring and oversight of junior staff and Clinical Research AssociatesProvide necessary training to CRAs, support site visits as neededDevelop training plan(s) for CRAs and related team membersCo-monitoring with BeiGene CRAs if needed to ensure oversight and address site related concernsAssist with the identification of development opportunities for junior team membersEducation Required: BS in a relevant scientific discipline and minimum of 5 year of relevant Clinical Operations experience and minimum of 3 years of monitoring experience. Experience in oncology global trials preferredComputer Skills: Efficient in Microsoft Word, Excel, and OutlookOther Qualifications: Understands clinical trial processes with a thorough knowledge of ICH and associated regulatory guidelines3-5 years of (CRA) monitoring experience in the pharmaceutical or CRO industryExcellent communication and interpersonal skillsExcellent organizational skills and ability to prioritize and multi-taskFluent in English (writing and speaking) and PolishTravel: up to 40-70% timeGlobal CompetenciesWhen we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity, and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world. Fosters TeamworkProvides and Solicits Honest and Actionable FeedbackSelf-AwarenessActs InclusivelyDemonstrates InitiativeEntrepreneurial MindsetContinuous LearningEmbraces ChangeResults-OrientedAnalytical Thinking/Data AnalysisFinancial ExcellenceCommunicates with ClarityWe are proud to be an equal opportunity employer. BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. Originally posted on Himalayas Apply To this Job