Manager of Clinical Research
Manager of Clinical Research: June 2011 to Present Experience-46 protocols As head of the department, report directly to the CEO/President with 7 direct reports Prepare and maintain a research specific financial database including invoicing Participate as needed in Investigator Meetings. Work as the lead of the research team of a private pediatric practice for drug development in Phase II-IV studies to grow and maintain a clinical research program. Manage the overall departmental efforts by way of strategic planning. Manage the data quality assurance/quality control program and provide training to the research staff for error prevention. Conduct biweekly individual meetings with departmental staff and weekly staff meetings. Serve as a creative resource for source document and enrollment log creation. Manage the continuing training and development of new team members. Experience with audits including fastest enroller Sponsor audit, top enroller Sponsor audit, medidata audit, and top enroller FDA audit prep. Research Coordinator II: November 2009 to June 2011 Obtained Certification for Clinical Research Coordinator through ACRP. Created, reviewed, and edited source documents for completeness against study protocols. Ensured resolution of CRA follow-up letters within 5 business days. Oversaw and trained research coordinators and research assistants to ensure adherence to protocols, ethical standards and standard operating procedures Mentored research coordinators and research assistants to improve time management skills and prioritization Research Coordinator: April 2008 to November 2009 Ensured adherence to protocols, ethical standards and standard operating procedures Ensured the time management skills and prioritization to carry out a full assignment Phlebotomy, Data Entry, Documentation, Consenting, Regulatory, Quality Assurance, Back-up start-up and close-out duties Served as administrative and recruitment back-up to the research team.