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Senior Clinical Research Associate Cardiovascular

Company name
Novella Clinical

Chicago, IL

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Description BASIC FUNCTIONS: Participatesin the preparation and execution of Phase I-IV clinical trials. Oversees theprogress of clinical investigations by conducting site evaluation, initiation,and interim close out visits to sites. Monitors clinical trials in accordance with Good Clinical Practices andprocedures set forth by Novella and sponsors. Works closely with the ClinicalTrial Manager (CTM) and\/or Lead CRA t0 ensure all monitoring activities areconducted according to study requirements. The Senior CRA may also serve in theLead CRA role. SENIOR CRA ESSENTIAL JOBFUNCTIONS, DUTIES AND RESPONSIBILITIES: \u00b7Participatesin the investigator recruitment process. Performs site evaluation visits of potentialinvestigators. Evaluates the capability of the site to successfully manage andconduct the clinical study. \u00b7Collaborateswith the ISSC department to coordinate activities with the site in preparationfor the initiation of the study. Obtains regulatory documentation forsuccessful implementation, monitoring, and evaluation of clinical trials. Workswith ISSC and site staff to obtain regulatory (IRB\/IEC) approval of studyspecific documents \u00b7Performsstudy initiation activities, reviewing with the site personnel the protocol,regulatory issues, study procedures, and provides training on completion of theeCRF; monitoring activities and study close-out activities. \u00b7Trainssite staff on the EDC system and verifies site computer system. \u00b7Assistsin resolving any issues in order to ensure compliance with site file audits inconjunction with ISSC. \u00b7Assuresadherence to Good Clinical Practices, investigator integrity, and compliancewith all study procedures through on-site monitoring visits. Performsvalidation of source documentation as required by sponsor. Prepares monitoringreports and letters per the timelines defined in Novella SOPs by using approvedNovella\/sponsor templates and reports. \u00b7Documentsaccountability, stability and storage conditions of clinical trial materials asrequired by sponsor. Performsinvestigational product inventory. Ensures return of unused materials to designated location or verifiesdestruction as required. \u00b7Reviewsthe quality and integrity of the clinical data through (1) in house review ofelectronic CRF data and (2) on-site source verification. Works with sites toresolve data queries. \u00b7Mayreview protocols, eCRFs, study manuals and other related documents, asrequested by the Clinical Trial Manager and\/or Lead CRA. \u00b7Servesas primary contact between Novella and investigator; coordinates allcorrespondence; ensures timely transmission of clinical data with the studysite and technical reporting, as requested. \u00b7Performsstudy close-out visits per the study specific Clinical Monitoring Planincluding final investigational product reconciliation and disposition, sitestudy file reconciliation, data query resolution through to database lock andresolution of outstanding action items. \u00b7Assistswith, and attends, Investigator Meetings for assigned studies. \u00b7Authorizedto request site audits due to data integrity concerns. \u00b7Attendsstudy-related, company, departmental, and external meetings, as required. \u00b7Ensuresinternal and study-related trainings are completed per Novella and\/or studytimelines; CTMS should be current at all times with the pertinent siteupdates\/contacts. \u00b7Ensuresall study deliverables are completed per Novella and study timelines \u00b7ConductsField Evaluation Visits and field training of CRA Is, IIs and other Sr. CRAs. \u00b7Servesas mentor for junior CRAs and those new to the company and\/or study. \u00b7Performsother duties, as requested. Qualifications KNOWLEDGE, SKILLS ANDABILITIES: \u00b7Strongknowledge of clinical research process, including working knowledge of allfunctional areas of clinical trials and medical terminology. \u00b7Four years of oncology experience and\/or medical device. \u00b7Experiencein monitoring and\/or coordinating clinical trials required. \u00b7Excellentwritten and verbal communication skills to express complex ideas to studypersonnel at research and clinical institutions. \u00b7Demonstratedability to form strong functional relationships. \u00b7Excellent,presentation, organizational and interpersonal skills. \u00b7Abilityto interact with all levels of staff to coordinate\/execute study activities. \u00b7Abilityto handle several priorities within multiple, complex trials. \u00b7Abilityto reason independently and recommend specific solutions in clinical settings. \u00b7Ableto mentor other CRAs and co-monitor, as required. \u00b7Understandelectronic data capture including basic data processing functions. \u00b7Understandingof current GCP\/ICH guidelines applicable to the conduct of clinical research. \u00b7Ableto qualify for a major credit card. \u00b7Validdriver\u2019s license; ability to rent automobile. \u00b7Forthe Technical CTM role, the CRA must have a deep understanding of Novellasystems with the ability to learn even more. CRITICAL JOB FUNCTIONSIN ACCORDANCE WITH ADA CRITERIA: \u00b7Abilityto travel domestically and internationally \u00b7Verylimited physical effort required to perform normal job duties MINIMUM RECRUITMENTSTANDARDS: \u00b7BS\/BA\/BSc(or equivalent) in one of the lifesciences or health care background (RPh, RN, etc) or equivalent amount ofeducation. \u00b7Aminimum of four (4) years of monitoring\/site management experience is required. \u00b7Computerliteracy and knowledge of electronic data capture required. \u00b7Mustpossess excellent verbal and written communication, interpersonal, andorganizational skills. \u00b7Requiresand ability to work independently, prioritize, and work within a matrix teamenvironment. \u00b7PriorClinical Research Organization (CRO) experience preferred. \u00b7Priorproject team leadership experience preferred. \u00b7Workingknowledge of budget management preferred. \u00b7Mustbe able to travel domestically and internationally approximately 65%-85%. EEO Minorities\/Females\/Protected Veterans\/Disabled

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Novella Clinical

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