COLLEEN

MCVANNAN

***- ***-****

ad3etu@r.postjobfree.com

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

•

• 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

•

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.

•

• 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

•

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

•

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

•

• 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

•

• 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

•

Collaborated closely with physicians and nursing staff to improve quality of patient records documentation

•

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

•

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.

•

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

Contact this candidate