Terumo BCT Sr Clinical Research Associate in Lakewood, Colorado

Sr Clinical Research AssociateDate: May 11, 2018Location:Lakewood, CO, US Company: Terumo BCT, Inc.State: Colorado (US-CO)JOB TITLE: Sr Clinical Research AssociateJOB SUMMARYParticipates in the operational implementation and execution of both pre- andpost-market clinical trial(s) in the US and/or globally. Responsible formanagement of clinical trial sites, ensuring compliance with regulations,Clinical Investigation Plan (CIP), and overall clinical objectives.Reviews and analyzes clinical data, may be involved with vendor managementand assists with ensuring study sites adhere to study budget and timelines.Maintains a high level of professional expertise through familiarity withcliniESSENTIAL DUTIESLead operational aspects of clinical trials including document development,investigator recruitment, participant enrollment, study trackers, studyspecific guidelines/processesAuthor/review/revise study documents such as Informed Consent Formtemplates, Study Management and Monitoring Plans, site trainingmaterials, Case Report FormsCreate study tools/documentsAssist in coordination efforts of cross-functional project team. May leadcross-functional project team meetingsAssist in the coordination of investigator meetings and development ofpresentation materials, as applicableConduct site feasibility, initiation, routine monitoring, and studycloseout visits. Prepare study monitoring reports, per Standard OperationProcedures (SOPs) and applicable regulations. May review and approvemonitoring reports of junior CRAs as assignedMonitor, track, and manage all study related tasks at study sites ensuringcompliance with Good Clinical Practice (GCP), International Conferenceon Harmonization (ICH), applicable regulations and company SOPsCollect, review, track, and ensure appropriate completion ofsite-specific study/essential documents. Performs ongoing reconciliation ofthe Trial Master File (TMF) content to site files. May conduct audits ofTMF per study management plansPrimary contact for study site personnelProvide training to site personnelTrack and report progress of study sitesResponsible for quality data from study sites. Ensure appropriate sourcedocumentation, training, and accurate transcription of data into the studyCase Report Form (CRF) as evidenced by minimal data query rates. Ensuretimely reconciliation of data queries and implementation of processimprovement/corrective action when needed. Assist in timeline developmentfor overall study data review and site closeoutMay take meeting minutes, develop and maintain study trackers, or assumeother tasks to support study teamAssist in management of vendorsCoordinate, assemble, and ship study related supplies as neededProvide training, guidance, and mentoring to junior CRAsMaintain awareness of overall development in the field of clinical researchbased on current literature, attendance at professional meetings,continuing education, etc.MINIMUM QUALIFICATION REQUIREMENTSEducationBachelor's degree in nursing or biological sciences or in a relatedscientific discipline or, equivalent of education and experience sufficientto successfully perform the essential functions of the job may be considered.ExperienceMinimum 4 years experience. Prefer experience as a Clinical ResearchAssociate in the medical device, diagnostic or pharmaceutical industries.SkillsSelf-directed with ability to work independentlyHas a broad understanding of applicable GCP, ICH, CFR, ISO regulationsEffective leadership and cross-functional skills within a teamPositive and a proactive approach to identification and definition ofproblems, and with the development and implementation of solutionsHigh level of adaptability, initiative, and willingness to take ownershipand accept responsibility for actions and decisionsHave the necessary interpersonal and communication skills to establishprofessional working relationships with colleagues and site personnelExcellent oral and written communication and presentation skillsAttention