Project Manager Registered Nurse
Resume:
PAMELA HIBBITTS
ABINGDON VA ***11
HOME: 276-***-****
MOBILE 276-***-****
PROFILE
Over 22 years of medical industry experience including 12 years in clinical research. Experience in Clinical Monitoring, Quality Assurance and Clinical Operations Management.
CAREER HISTORY
September 2011- February 2012 Manager, Clinical Operations
PRA International
US
Responsible for direct management responsibilities for 20 CRAs of various experience levels.
Responsible for providing support to team members in their career development activities. Implementation/Management of Performance Improvement Plans when applicable. Conduct annual Quality Assessment Visits with direct reports. Conduct review and approval of expense reports and weekly timesheet review and approval. Responsible for other departmental activities as needed.
August 2009 to September 2011 Senior Manager, Clinical Monitoring
Chiltern International, LLC
US
Responsible for direct management responsibilities for 16 Senior Clinical Research Associates as well as departmental responsibilities. Supports the day-to-day activities of team members and ensuring quality standards are maintained. Responsible for providing support to team members in their career development activities. Implementation/Management of Performance Improvement Plans when applicable. Conduct annual Quality Assessment Visits with direct reports. Conduct review and approval of expense reports and weekly timesheet review and approval. Responsible for other departmental activities as needed. Supports the training and induction of Managers and PCRAs, and provide guidance and assistance as required. Identify need for and conduct departmental training as necessary.
Key areas of Responsibility:
• Line management responsibilities for Sr. CRAs, PCRAs and CMO Line Managers
• Ensure team members are complying with all job description requirements through conduct of accompanied assessment visits and documentation review
• Conduct various departmental training sessions
• Annual review of training files to identify direct report compliance with training and SOP review requirements.
May 2008- August 2009 Manager, Clinical Monitoring
Chiltern International, LLC
US
Responsible for line management tasks in the support of day-to-day activities of clinical monitoring team members and ensuring quality standards are maintained. Responsible for providing support to team members in their career development activities. Responsible for other departmental activities as needed.
Key areas of Responsibility:
• Line management responsibilities for Trainee CRAs, CRA 1s, CRA 2s, Sr. CRAs, CTLs and PCRAs
• Ensure team members are complying with all job description requirements through conduct of accompanied assessment visits and documentation review
• Conduct various departmental training sessions
• Annual review of training files to identify direct report compliance with training and SOP review requirements.
October 2007- May 2008 Senior Quality Assurance Associate
Chiltern International, LLC
US
Assist with and/or initiate planning, coordinating and conducting routine system audits; oversee and coordinate QA database audits for Data Management; and conduct external audits as needed to ensure that Standard Operating Procedures, Good Clinical Practices, applicable federal
regulations, and office policies are being observed. Provide FDA regulation and ICH-GCP training as necessary.
Therapeutic Area /Lab Experience
• Internal System Audits
• Trial Master File Audits
• Laboratory Vendor Audits
• IVRS Vendor Audits
• Data Management QA Audits
Key areas of Responsibility:
• Plan and conduct internal system audits; Trial Master File audits; investigator site audits; vendor audits and other sponsor contracted audits
• Coordinate and supervise the conduct of QA database audits for Data Management
• Conduct internal GCP and FDA inspection preparedness training
• GCP consultant for internal employees
• Participate in new CRA training and project manager training
• SOP development and maintenance
• Primary backup for validation efforts and change control request including document review and assessment for compliance with 21CRF Part 11
• Plan and facilitate sponsor audits
• Plan and facilitate regulatory agency inspections
April 2007 - October 2007 Senior Quality Assurance Associate
CTMS, Inc. Acquired by Chiltern International in February 2008
US
Assist with and/or initiate planning, coordinating and conducting routine system audits; oversee and coordinate QA database audits for Data Management; and conduct external audits as needed to ensure that Standard Operating Procedures, Good Clinical Practices, applicable federal regulations, and office policies are being observed.
Therapeutic Area /Lab Experience
• Internal System Audits
• Trial Master File Audits
• Laboratory Vendor Audits
• IVRS Vendor Audits
• Data Management QA Audits
Key Areas of Responsibility
• Plan and conduct internal system audits; Trial Master File audits; investigator site audits; vendor audits and other sponsor contracted audits
• Coordinate and supervise the conduct of QA database audits for Data Management
• Conduct internal GCP and FDA inspection preparedness training
• GCP consultant for internal employees
• Participate in new CRA training and project manager training
• SOP development and maintenance
• Primary backup for validation efforts and change control request including document review and assessment for compliance with 21CRF Part 11
• Plan and facilitate sponsor audits
• Plan and facilitate regulatory agency inspections
February 2003 – October 2007 Quality Assurance Associate
CTMS, Inc
US
Assist with and/or initiate planning, coordinating and conducting routine system audits; oversee and coordinate QA database audits for Data Management; and conduct external audits as needed to ensure that Standard Operating Procedures, Good Clinical Practices, applicable federal regulations, and office policies are being observed.
Therapeutic Area Experience
• Anaesthesia/Pain Management
• Infectious Disease
• Ophthalmology
• Endocrinology
Key Areas of Responsibility
• Plan and conduct internal system audits; Trial Master File audits; investigator site audits; vendor audits and other sponsor contracted audits
• Coordinate and supervise the conduct of QA database audits for Data Management
• Conduct internal GCP and FDA inspection preparedness training
• GCP consultant for internal employees
• Participate in new CRA training and project manager training
• SOP development and maintenance
• Primary backup for validation efforts and change control request including document review and assessment for compliance with 21CRF Part 11
• Plan and facilitate sponsor audits
• Plan and facilitate regulatory agency inspections
August 1999- February 2003 Clinical Research Associate
CTMS, Inc
Monitored and managed study sites which included conducting pre-study; initiation; interim and close out visits plus in-house site management activities.
Therapeutic Area Experience
• Nervous System
• Respiratory
• COPD
April 1990-August 1999 Cardiovascular Nurse
Welmont- Bristol Regional Medical Center, Bristol, TN
Registered Nurse
Therapeutic Area Experience
• Cardiac Catherization 5 years
• Cardiac and Medical Intensive Care 1year
• Progressive Coronary Care 3years
Key Areas of Responsibility
• 1989-1990- Patient Care Technician
• 1990-1993- Registered Nurse (Charge Nurse)- Progressive Coronary Care
• 1993-1994- Registered Nurse- Cardiac and Medical Intensive Care
• 1994-1999- Cardiovascular Nurse- Cardiac Catherization Lab
QUALIFICATIONS & TRAINING
1998 Bachelor of Science- Nursing
Old Dominion University, Norfolk, VA
1990 Associate Degree-Nursing Southwest Virginia Community College, Richlands, VA
1987 Associate Degrees- General Studies and Science Southwest Virginia Community College, Richlands, VA
1990 - Present Registered Nurse- Commonwealth of Virginia
Proficient with Microsoft Office Applications and Lotus Notes
References available upon request
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