Clinical Research Coordinator

ASK Consulting is hiring a Clinical Research Coordinator to conduct clinical research and independently manage significant aspects of large studies or all aspects of one or more smaller studies. The role oversees participant recruitment, study data, regulatory compliance, budgets, and coordination with investigators and sponsors.

Responsibilities

• Oversee subject recruitment and study enrollment goals. Determine effective strategies for promoting/recruiting research participants and retaining participants in long-term clinical trials
• Oversee data management for research projects. Develop and manage systems to organize, collect, report, and monitor data collection. Extract, analyze, and interpret data
• Develop project schedules, targets, measurements, and accountabilities, as assigned. Lead team meetings and prepare/approve minutes
• Formally supervise, train, and/or mentor new staff or students, as assigned, potentially including hiring, preparing or assisting with the preparation of performance evaluations, and performing related duties, in addition to instruction on project work
• Audit operations, including laboratory procedures, to ensure compliance with applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions and respond to requests and questions
• Collaborate with principal investigators and study sponsors, monitor and report serious adverse events, and resolve study queries
• Provide leadership in determining, recommending, and implementing improvements to policies/processes; define best practices
• Develop study budget with staff and principal investigator, identifying standard of care versus study procedures. Track patient- and study-specific milestones, and invoice sponsors according to study contract
• Ensure regulatory compliance. Regularly inspect study documents to ensure ongoing regulatory compliance
• Work with the principal investigator to ensure Investigational New Drug applications are submitted to the FDA when applicable. Ensure Institutional Review Board renewals are completed

Preferred

• Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred
• SOCRA
• ACRP Certification

Benefits

• Hybrid and onsite 4 days/week during training, then 3-4 per week

Company

• Global recruiting firm for enterprise staffing and talent acquisition
• Alpharetta, Georgia, USA
• https://www.askconsulting.com/
• Founded in 1995
• 501-1000 employees

Qualifications

• 2 years
• on-site coordinator experience
• EPIC experience
• oncology
• treatment trials
• Strong interpersonal skills
• Proficiency in Microsoft Office and database applications
• Experience with research protocols and regulatory or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practice
• Knowledge of medical terminology
• Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience
• On-site coordinator experience
• Oncology
• Treatment trials
• Society of Clinical Research Associates or Association of Clinical Research Professionals certification is preferred
• Bachelor's degree in a related field and two years of experience in clinical research, or an equivalent combination of education and relevant experience.

Required skills

• Clinical Practice (GCP), EPIC, FDA Regulations, HIPAA, Institutional Review Board (IRB) Requirements, Medical Terminology, Microsoft Office, On-site Clinical Research Coordination, Oncology, SoCRA or ACRP Certification, Treatment Trials

Experience

• 2+ years