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Posted: Sunday, February 4, 2018 3:25 PM

Requisition ID 52508BR
Title Clinical Research Associate Field Management Austin Texas
Job Category Clinical Development
Job Description Purpose
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 Standard Operating Procedure (SOPs). Close collaboration with other members within Clinical Trial Management (CTM) and with various representatives within Clinical Medical Regulatory (CMR).
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.
Essential Functions
Coordination/Communication, Administration and Personnel Development: Ensures compliance with the application and communication of all Novo Nordisk(R) policies, procedures and fundamentals. Functional Support: May participate in continuous improvement processes for function.
Project Support: 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) . 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. 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. Attains thorough understanding of study management tasks and responsibilities necessary to implement compliance with protocol/regulatory requirements and Novo Nordisk Inc. (NNI) SOPs. Attends Investigator Meetings and study:specific training for assigned trials. Attends site audits according to the CTM Audit Management Plan and executes audit action plans with support from Lead CRA/PM as appropriate. 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. Completes Site Selection, Site Initiation, Routine Monitoring and Closeout Visits according to SOPs, and completes reports and follow:up letters to quality standards within company specified timelines. Develops and maintains collaborative working relationships with clinical investigative sites. Accountable for data integrity, patient safety and regulatory compliance for all assigned sites. Knowledgeable of assigned protocol(s) and trial:specific manuals/plans to ensure quality and deliverables are met across assigned sites. 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. Monitors recruitment and data quality while on site and remotely through EDC systems and communication with sites. Performs on:site drug accountability, reconciliation and return. Verifies trial product storage meets protocol and SOP requirements.
Staff Development: May provide guidance, mentoring and training to less experienced CTM staff to build talent across the department. May support the maintenance of guidelines, training programs, policies and procedures.
Team Coordination: A


• Location: Austin

• Post ID: 28910957 austin is an interactive computer service that enables access by multiple users and should not be treated as the publisher or speaker of any information provided by another information content provider. © 2018