Clinical Research Associate Field Management
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, International Council of Harmonisation Guidelines, federal regulations and Standard Operating Procedure's. Close collaboration with other members within Clinical Trial Management and with various representatives within Clinical, Medical & Regulatory.
Reports to a Manager/Senior Manager/Associate Director of Field Management within Clinical Trial Management. 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.
Coordination/communication, administration & personnel development: Ensures compliance with the application and communication of all Novo Nordisk® 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 Clinical Trial Management escalation pathway to the Lead Clinical Research Associate. 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 with investigative sites with oversight from Lead Clinical Research Associate. Assures adequate and appropriate dissemination of information between project team members to ensure project success in accordance with the Clinical Trial Management 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. Standard Operating Procedures. Attends Investigator Meetings and study-specific training for assigned trials. Attends site audits according to the Clinical Trial Management Audit Management Plan and executes audit action plans with support from Lead Clinical Research Associate as appropriate. Collaborates with the Lead Clinical Research Associate(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 Clinical Trial Management escalation pathway to the Lead Clinical Research Associate(s) as appropriate. Completes Site Selection, Site Initiation, Routine Monitoring and Closeout Visits according to Standard Operating Procedures, 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 in accordance with Novo Nordisk Standard Operating Procedures. Performs on-going reviews of Investigator Trial Files to assure quality of the documentation and compliance with Novo Nordisk Standard Operating Procedures, Good Clinical Practice and International Council Harmonisation Guidelines while on site. Monitors recruitment and data quality while on site and remotely through Electronic Data Capture systems and communication with sites. Performs on-site drug accountability, reconciliation and return. Verifies trial product storage meets protocol and Standard Operating Procedures requirements. Staff Development: May provide guidance, mentoring and training to less experienced Clinical Trial Management staff to build talent across the department. May support the maintenance of guidelines, training programs, policies and procedures. Team Coordination: Active participation on local project teams. Ensures the mandatory trial entries are made in the applicable Novo Nordisk systems. Maintains focus for specific project activities within Clinical, Medical & Regulatory priorities. Participates in cross-functional teams, locally, to assure timely attainment of project milestones. Responsible for the compliance and quality of Cross Application Timesheet reporting for self. Training: Attends relevant symposia, conferences and scientific meetings, as necessary. May provide support of training needs across Clinical Trial Management and may support the creation, development and potentially provide training support to meet those needs. This includes sharing of lessons learned across the project team members and/or Clinical Trial Management.
50-75% overnight travel required. Must live within 50 miles of the regional workload center within assigned region.
- A minimum of 2 years of on-site monitoring experience (with Bachelors degree) or 3 years of on-site monitoring experience (with Registered Nurse)
- A minimum of 4 years of clinical trialexperience within a pharmaceutical, biotechnology, Clinical Research Organization, and/or healthcare setting; some experience in area of specialty preferred
- A Registered Nurse (RN) or Bachelor’s degreerequired (in science-related discipline preferred)
- Demonstrated computer skills (MS Office, MS Project, MS PowerPoint)
- Demonstrates core understanding of medical terminology and clinical trial activities in relation to execution of a clinical development plan
- Knowledge of Good Clinical Practice as relates to clinical trial management.