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Posted: Tuesday, September 12, 2017 3:09 PM

Requisition ID 49818BR
Title Regional Clinical Research Associate : Miami FL
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 SOPs. Close collaboration with other members within Clinical Trial Management (CTM) and with various representatives within Clinical Development, Medical and Regulatory Affairs (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.
* Ensure compliance with the application and communication of all Novo Nordisk(R) policies, procedures and fundamentals.
* May participate in continuous improvement processes for function.
* Act as primary liaison for assigned study sites while on:site to convey project information, answer questions and in accordance with the CTM escalation pathway to the Lead CRA resolve site related issues
* 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
* Attains thorough understanding of study management tasks and responsibilities necessary to implement compliance with protocol/regulatory requirements and 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 specifics 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) and CRAs as appropriate
* Completes follow up letters from all visit types according to SOPs and completes reports to quality standards within company specified timelines
* Completes Site Selection, Site Initiation, Routine Monitoring and Close:out Visits according to SOPs and completes reports 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
* Monitors recruitment and data quality while on site and remotely through EDC systems/communication with sites
* Performs on:site drug accountability and reconciliation. Verifies drug storage meets protocol and SOP requirements
* Responsible for maintaining current Investigator Trial File (ITF) in accordance with NNI SOPs
* Performs ongoing reviews of ITF to assure quality of the documentation files and compliance with NNI SOPs, GCP and ICH Guidelines while on site
* Responsible for assuring adequate and appropriate dissemination of information according to the study specific communication plan between project team members to ensure project success in accordance with the CTM Communication Pathway or Project Specific Communication Plan
* Understanding of assigned protocol (s) and trial specific manuals/plans to ensure quality and deliverables are met across assigned sites.
* May provide active mentorship of CTM staff


• Location: Miami

• Post ID: 65201243 miami 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. © 2017