Requisition ID 44848BR<br/>Title Sr. Regional Clinical Research Associate-Biopharm - Orlando, FL<br/>Job Category Clinical Trial Management<br/>Job Description PURPOSE:<br/>Responsible for performing study activities regarding the implementation, monitoring and summarization of clinical trials to ensure patient safety and adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, federal regulations and SOPs. Close collaboration with other members within Clinical Trial Management (CTM) and with various representatives within Clinical Development, Medical and Regulatory Affairs (CMR).<br/><br/>RELATIONSHIPS:<br/>Reports to a Manager/Senior Manager/Associate Director of Field Management (FM) within CTM. Accountable for actively participating in multiple internal cross-functional teams locally to ensure the effective delivery of assigned project milestones. External relationships are with clinical investigators, and other clinical research vendors as needed to support business objectives for the department and/or function.<br/><br/>ESSENTIAL FUNCTIONS:<br/><br/>COORDINATION/COMMUNICATION, ADMINISTRATION & PERSONNEL DEVELOPMENT:<br/>* Ensures compliance with the application and communication of all Novo Nordisk® (NNI) policies, procedures and fundamentals<br/><br/>FUNCTIONAL SUPPORT:<br/>* Participates in continuous improvement processes for function<br/><br/>PROJECT SUPPORT:<br/>* Acts as primary liaison for assigned study sites while on-site to convey project information, answer questions and resolve site related issues in accordance with the CTM escalation pathway to the Lead Clinical Research Associate (CRA)<br/>* Assists the project team in preparation for audits/inspections and is responsible for the quality and completeness of site related performance and documentation. Prepares, collaborates and implements Corrective Action Plans (CAP) with investigative sites with oversight from Lead CRA<br/>* Assures adequate and appropriate dissemination of information between project team members to ensure project success in accordance with the CTM Communication Pathway or Project Specific Communication Plan<br/>* Attains thorough understanding of study management tasks and responsibilities necessary to implement compliance with protocol/regulatory requirements and NNI SOPs<br/>* Attends Investigator Meetings and study-specific training for assigned trials<br/>* Attends site audits according to the CTM Audit Management Plan and executes audit action plans with support from Lead CRA/PM as appropriate<br/>* Collaborates with the Lead CRA(s) to obtain/share trial-specific issues across all study sites concentrating on areas related to quality, site performance and metrics. Responsible for communicating issues in accordance with the CTM escalation pathway to the Lead CRA(s) as appropriate<br/>* Completes site selection, site initiation, routine monitoring and close-out visits according to SOPs and completes reports and follow-up letters to quality standards within company specified timelines<br/>* Develops and maintains collaborative working relationships with clinical investigative sites<br/>* Accountable for data integrity, patient safety and regulatory compliance for all assigned sites<br/>* Knowledgeable of assigned protocol(s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned sites<br/>* Maintains current Investigator Trial Files (ITF) in accordance with NNI SOPs. Performs ongoing reviews of ITF to assure quality of the documentation and compliance with NNI SOPs, GCP and ICH Guidelines while on site<br/>* Monitors recruitment and data quality while on site and remotely through EDC systems and communication with sites<br/>* Performs on-site drug accountability, reconciliation and return. Verifies trial product storage meets protocol and SOP requirements.<br/><br/>STAFF DEVELOPMENT:<br/>* May support the maintenance of guidelines, training programs, policies and procedures<br/>* Provides guidance, training and mentorship of CTM staff to build talent across the department.<br/><br/>TEAM COORDINATION:<br/>* Accountable for the compliance and quality of CATS reporting for self<br/>* Active participation on local project teams<br/>* Ensures mandatory trial entries are made in the applicable NNI systems<br/>* Maintains focus for specific project activities within CMR priorities<br/>* Participates in cross-functional teams, locally, to assure timely attainment of project milestones.<br/><br/>TRAINING:<br/>* Attends relevant symposia, conferences and scientific meetings, as necessary<br/>* May identify training needs, develop training materials to meet those needs, and provide training as required to improve core competency and skill set of the department<br/>* This includes sharing of lessons learned and best practices across the project team members and/or CTM<br/><br/>PHYSICAL REQUIREMENTS:<br/>* 50-75% overnight travel required<br/>* Must live within 50 miles of the regional workload center within assigned region<br/><br/>QUALIFICATIONS:<br/>* A Bachelor’s degree (preferably in science-related discipline) or Registered Nurse (RN) designation is required<br/>* A minimum of six (6) years’ of progressively responsible clinical trial experience within a pharmaceutical, biotechnology, CRO, and/or healthcare setting is required<br/>* A minimum of four (4) years’ of on-site monitoring experience (with Bachelor’s Degree) or five (5) years’ of on-site monitoring experience (with RN) is required<br/>* Knowledge of GCP as it relates to clinical trial management is required<br/>* Must have a core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan<br/>* Must have demonstrated computer skills (MS Office, MS Project, MS PowerPoint)<br/><br/>Department CMR - FIELD MGMT BIOPHARM (1)<br/>Position Location US - Field Based - Across US<br/>City Orlando<br/>State/Provinces US - FL
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<br/><br/><p class="eeo_desc">Novo Nordisk is committed to equal employment opportunity and providing reasonable accommodations to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, physical or mental disability, medical condition, veteran status, genetic information, or any other characteristic protected by federal, state, or local law.<br/><br/>
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