Amanda Fletcher
Lakeland
Summary
Experienced leader specializing in clinical trial management and regulatory compliance at West Cancer Center. Proven ability to develop effective research strategies and improve financial oversight. Expertise in data analysis and team collaboration, driving successful results in challenging research settings.
Overview
31
31
years of professional experience
Work History
Vice President-Research Services
West Cancer Center
Memphis
12.2020 - Current
- Provides operational oversight for clinical research team supporting the cancer center.
- Responsible for creating research strategies, improving process methods, and optimizing the research environment.
- Communicates progress of research program to key leadership and stakeholders.
- Ensures regulatory compliance and financial stability for robust phase 1-3 portfolio.
Director of Research Nursing
West Cancer Center
Memphis
08.2016 - 12.2020
- Responsible for oversight of the nursing staff team supporting clinical trials for the cancer center.
- Ensures compliance of the clinical trials program to Federal and State regulations.
- Works closely with site PI’s on all aspects of clinical trials conducted at the center.
- Implements training and educational opportunities as required for the Research Team.
Senior Clinical Study Manager
Smith & Nephew
Memphis
03.2016 - 08.2016
- Responsible for conducting clinical studies to support Regulatory Affairs submissions and the Post Marketing Surveillance of company products.
- Responsible for the preparation of clinical study documents such as protocols, informed consent forms, site monitoring reports and study summaries.
- Manage contracts to ensure that clinical projects are completed according to timelines and quality.
- Facilitates IRB/Ethics committee submissions.
Senior Manager Research Services
ACORN Research LLC/ The West Clinic, P.C.
Memphis
03.2014 - 03.2016
- Management responsibilities include recruitment, implementation and continued oversight of clinical research protocols.
- Provide supervision of Project Management and Data Management Teams.
- Work closely with Sponsor, CRO, Investigator, Clinical Site Staff, Data Management, Regulatory, Quality Assurance and Contracting to ensure all timelines are met or exceeded.
- Provides training to other clinical research personnel.
- Coordinate CITI GCP training Program for Clinical Research Staff.
- Oversight of Quality Assurance Program which includes training of research staff, Coordination of CITI training for Investigators/Staff and serve as Quality Assurance liaison for Sponsor/CRO.
Manager Project Management-Industry Trials Division
ACORN Research LLC/ The West Clinic, P.C.
Memphis
03.2011 - 03.2014
- Management responsibilities included recruitment, implementation and continued oversight of clinical research protocols conducted within a multiple practice oncology network.
- Provided supervision of Project Management team.
- Worked closely with Sponsor, CRO, Investigator, Clinical Site Staff, Data management, Regulatory, Quality Assurance and Contracting to ensure all timelines are met or exceeded.
- Assisted in the development of proposals to clients.
- Provided training to other clinical research personnel.
- Prepares and presents project status reports to clients and ACORN senior management.
- Coordinated Annual Investigator and Study Coordinator meeting.
Project Manager-Industry Trials Division
ACORN Research LLC/ The West Clinic, P.C.
Memphis
01.2008 - 03.2011
- Management responsibilities included recruitment, implementation and continued oversight of clinical research protocols conducted within a multiple practice oncology network.
- Worked closely with Sponsor, CRO, Investigator, Clinical Site Staff, Data management, Regulatory, Quality Assurance and Contracting to ensure all timelines are met or exceeded.
- Assisted in the development of proposals to clients.
- Provided training to other clinical research personnel.
- Prepares and presents project status reports to clients and ACORN senior management.
- Coordinated Annual Investigator and Study Coordinator meeting.
Regional Site Manager Non-Oncology Division
SCRI/Summit Research Solutions
Memphis
05.2003 - 11.2007
- Management responsibilities included oversight of clinical research activities for corporate office and 16 remote research locations.
- Duties included supervising clinical research personnel, assisting in the development of proposals to clients, provided training to other clinical research personnel, prepared and presented project status reports to clients and management.
- Research activities included the following therapeutic areas: Gastroenterology, Internal Medicine, Pediatrics, Obstetrics, Gynecology, Rheumatology, Ophthalmology and Dermatology.
- Coordinated project timelines and managed site logistics effectively.
- Facilitated communication between teams and stakeholders for project alignment.
Lead Research Coordinator
SCRI/Summit Research Solutions
Memphis
05.2003 - 11.2007
- Coordinated Phase II, III and IV pharmaceutical research trials.
- Responsible for all research related activities within 11 physician Gastroenterology Practice.
- Duties included data collection and reporting, monitoring patient condition, disease status, laboratory results and adherence to protocols as designed by pharmaceutical companies.
- Research indications included: Crohn’s, Irritable Bowel. Constipation, Colon Prep, Conscious Sedation, GERD, Diverticulitis, Anal Fissures, Hepatitis C and Gastric Ulcers.
Endoscopy Nurse
Memphis Gastroenterology Group
Memphis
06.1999 - 05.2003
- Responsibilities included Pre and post-operative care of patients undergoing ambulatory gastroenterology related procedures.
- Activities included pre and post-operative education, monitoring patients undergoing conscious sedation, IV insertions, EKG, phlebotomy and assisted physician in endoscopy procedures.
- Frequently assigned as a preceptor for new employees and cross training of current staff.
Staff Nurse
Methodist Hospitals of Memphis
Memphis
01.1995 - 05.2003
- Specialized in Medical/Surgical Telemetry, Diabetes and Ambulatory Care.
- Responsible for providing direct patient care through overall nursing assessment, IV therapy and medication administration.
Office Nurse
Gastrointestinal Specialists
Memphis
09.1995 - 06.1999
- Performed all office nurse duties including phlebotomy, EKG, telephone triage and nurse visits.
- Logistical support included coordination of all material requisitions, scheduling of patients, patient billing and HMO referrals.
- Assumed role of preceptor during indoctrination of new medical support personnel.
- Reviewed and distributed all patient education materials.
- Developed patient education programs for Hepatitis and GERD.
Education
Associates in Science - Registered Nurse
New York Regents College
Albany, New York01.1997
Diploma in Practical Nursing -
Methodist Hospital School of Practical Nursing
Memphis, Tennessee12.1994
Skills
- Clinical trial management
- Regulatory compliance
- Research strategy development
- Financial oversight
- Data analysis
- Stakeholder communication
Timeline
Vice President-Research Services
West Cancer Center
12.2020 - Current
Director of Research Nursing
West Cancer Center
08.2016 - 12.2020
Senior Clinical Study Manager
Smith & Nephew
03.2016 - 08.2016
Senior Manager Research Services
ACORN Research LLC/ The West Clinic, P.C.
03.2014 - 03.2016
Manager Project Management-Industry Trials Division
ACORN Research LLC/ The West Clinic, P.C.
03.2011 - 03.2014
Project Manager-Industry Trials Division
ACORN Research LLC/ The West Clinic, P.C.
01.2008 - 03.2011
Regional Site Manager Non-Oncology Division
SCRI/Summit Research Solutions
05.2003 - 11.2007
Lead Research Coordinator
SCRI/Summit Research Solutions
05.2003 - 11.2007
Endoscopy Nurse
Memphis Gastroenterology Group
06.1999 - 05.2003
Office Nurse
Gastrointestinal Specialists
09.1995 - 06.1999
Staff Nurse
Methodist Hospitals of Memphis
01.1995 - 05.2003
Associates in Science - Registered Nurse
New York Regents College
Diploma in Practical Nursing -
Methodist Hospital School of Practical Nursing