Quality Assurance Clinical Research
Resume:
COLLEEN
MCVANNAN
*********@*****.***
Endicott, NY 13760
CONTACT
SKILLS
• Encouraging manager
• Analytical problem-solver
• Team building
• Leading and motivating
• Excellent customer relations aptitude
• Relationship-building skills
• Independent decision-making skills
• Sound judgment
• Training
• Monitoring
• Morale-building abilities
• Quality control tests
• Knowledge of quality systems
• Policy reinforcement
• Staff training and development
• Employee supervision
• Quality assurance background
• Pre-implementation audits
• Data analysis
• Audit reporting
• Deficiency detection
Senior Manager for SWAT Team and Chart Abstractors Care Access, Hybrid
Quality Assurance Manager
Meridian Clinical Research, Endicott
EXPERIENCE
February 2022 - Present
Managed large-scale projects and introduced new systems, tools, and processes to achieve challenging objectives
•
• Evaluated hiring, firing, and promotions requests Reviewed and analyzed reports, records and directives to obtain data required
• for planning department activities
Conducted performance evaluations, compensations and hiring to maintain appropriate staffing requirements
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• Produced staffing matrix to provide adequate coverage of department
• Provided strong leadership to enhance team productivity and morale
• Developed proposals and presentations for internal and external audiences Developed and implemented new filing systems to improve organizational efficiency and productivity
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• Implemented and developed operational standards, policies and procedures Boosted team member productivity by enhancing performance monitoring and instituting motivational approaches
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Used strong analytical and problem-solving skills to develop effective solutions for challenging situations
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• Identified issues, analyzed information and provided solutions to problems Participated in team projects, demonstrating the ability to work collaboratively and effectively.
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• GCP (Good Clinical Practice)
• Monitoring Visits
• Evaluated the quality and integrity of study site practices Managed multiple high-priority projects simultaneously while meeting tight deadlines.
•
August 2018 - February 2022
• Lead and manage as guided by Director, Quality Assurance Supervised a team of Quality Assurance Specialist(s) and/or Embedded Quality Assurance Specialist(s)
•
Assist in training and supporting Quality Assurance Specialist(s) and Operations staff
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Coordinate with Director, Quality Assurance in assignment of staff
• responsibilities
Assist Director, Quality Assurance with weekly staff meetings to communicate information, provide continuing education, training and enhance teamwork
•
Director, Health Information/Director, Discharge P Susquehanna Nursing Home, Johnson City
Serve as an additional contact to PIs and Sub-Investigator(s), Regional Manager(s) and Site Directors/Managers
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Act as a liaison between Regulatory and sites as well as other departments
• within the company
Review all clinical research associate (CRA)/monitor follow-up reports/letters for each site visit from the sponsor or clinical/contract research organization (CRO)
•
Assist sites with compliance issues identified in the reports; assist with response and with writing corrective and preventative action (CAPA) plans when necessary
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• Internal compliance visits
• Once per year per coordinator at minimum
• Prior to sponsor audit
• Prior to FDA inspection Support Trial Conduct
• Review of study subject charts
• Protocol deviation tracking
• Standard Operating Procedures - annual review and revisions
• Clinical Operating Guidelines - annual review and revisions Ensure Training on GCP, federal regulations, SOPs, guidelines, and other relevant documents are current for investigators and research staff (directors, coordinators, assistants, etc.) Administrative Support Education
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• Assist with audit response
• Assist with writing Note to File (NTF) as needed Review of Trial Master Files for regulatory compliance Support Source Documentation Creation and Maintenance
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• Assist lead CRC with review of source documents prior to finalization
• Identify need for additional source documents or forms as needed.
• GCP (Good Clinical Practice)
• Site monitoring visits
August 2010 - August 2018
Recruited and hired top-performing individuals bringing undeniable experience and wealth of skills to organization
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Collaborated closely with physicians and nursing staff to improve quality of patient records documentation
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Directed work of lighting and sound crews to coordinate efficient production
• operations
Created annual budget and developed comprehensive plan to accomplish company objectives while staying within budget
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Monitored office workflow and administrative processes to keep operations running smoothly
•
Oversaw operations and provided corrective feedback to achieve daily and long-
• term goals
Worked closely with organizational leadership and board of directors to guide operational strategy.
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Bachelor of Science in Registered Health Information Administrator Suny Broome/USA, NY
Associate of Applied Science in Paralegal
Suny Broome/USA, NY
EDUCATION
January 2005
January 2005
CERTIFICATIONS
• Sigma 6
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