Clinical Research Manager (CRM)

Benefits

Qualifications

• •Minimum 1-2 years of experience as a lead Clinical Research Coordinator (CRC III)
• •Strong organizational and leadership skills with interest in professional growth
• •Excellent written and verbal communication skills
• •Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)
• •1 more items(s)

Responsibilities

• •The Clinical Research Manager (CRM) will be responsible for managing/supervising the entire research department (CRCs and Research Assistants) with all the aspects of clinical research (visits, regulatory compliance, financial management etc.) in accordance with department’s SOP, GCP, IRB and FDA guidelines
• •Assist in hiring new research staff with the help of practice administrator (HR)
• •Oversee day-to-day operations of research department
• •Train, mentor and supervise research staff conduct clinical trials in compliance with FDA, IRB, GCP and department’s SOP guidelines including maintaining study, regulatory and monitoring visit records
• •Conduct QI projects and Audits in accordance with SOP guidelines
• •Function as a liaison between investigators and research staff
• •Study start-up, close-out, and Clinical Trial Agreement (CTA) execution with Principal Investigator
• •Responsible for the research department’s financial activity and maintaining financial records
• •Organize meetings with research staff and Investigators and maintain meeting records
• •Maintain and update SOP, Meeting, Staff, Audit, Vendor and Financial binders
• •Maintain and update staff’s CVs, GCPs, IATA and study related training records
• •Conduct calibration checks and maintain records on annual basis
• •Maintain necessary equipment and supplies
• •Maintain and update Research drive with regular back-up
• •11 more items(s)