Clinical Research Associate (Central, US)
This role will support Kansas, Missouri, Tennessee, Nebraska, Illinois, Kentucky and Indiana.
CRA role requires understanding of medical and scientific concepts and language in order to effectively interpret protocol requirements, understand medical notes and effectively conduct monitoring activities.
Senior Clinical Research Associate:
Increased complexity of allocated studies, increased autonomy and requirement to contribute to process improvement require significant level of expertise in core role.
Clinical Research Associate:
• To perform site evaluations and provide recommendations on site selection, study initiation, data monitoring and collection, patient recruitment and retention evaluation and site close-out activities for assigned sites. Assist sites and the study team during audits/inspections. On-site visits may require up to 70% travel.
• Partner with Study Management and other relevant stakeholders to ensure optimal study conduct at assigned investigator sites in order to deliver on study objectives.
• Proactively manage the Trial Master File and Country File to required SOP and regulatory standards. Ensure compliance with inspection readiness requirements.
• Cultivate and maintain strong working relationships and communication with investigators, sites and GSK personnel.
• Identify, escalate and resolve all monitoring and regulatory issues in partnership with investigator, site personnel and study teams.
• Play a role in the development and implementation of efficient and effective approaches to study site management characterized by process standardization, best practice sharing and continuous improvement.
• Proven ability to function independently in a matrix environment
Senior Clinical Research Associate:
In addition to the basic duties described above:
• Provide leadership in representing monitoring interests to the study conduct team.
• Provide leadership in resolving complex monitoring and regulatory issues through discussion with Monitoring staff, project staff, or other GSK departments, as appropriate
• Take a leadership role in developing monitoring organization characterized by process standardization, best practice sharing, and continuous improvement
• Provide training for new monitoring personnel and contribute to their performance appraisals, as appropriate
• Individual contributor who demonstrates diligent and self-motivated approach to working in an off-site and independent work environment
Bachelor degree in medical, health and/or biological sciences or equivalent
3 years as a clinical research associate, with diverse experience in all stages of study activity (start-up, monitoring and close-out)
Communication skills, analytical skills (especially for Risk Based Monitoring), Influencing and negotiation skills; understanding of budgets and finance
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
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