Karen Anderson
Myrtle Beach,SC
Summary
Professional Site Manager with proven proficiency in OSHA compliance, internal and external communications, crew supervision and cost control. Committed to on-time project completions, cost effective budgeting and superb work quality. Experience with FDA audits and inspections.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Research Site Manager
MCB Clinical Research Centers
Colorado Springs, CO
07.2021 - 08.2023
- Managed daily operations of the site, including staff and contractors.
- Ensured compliance with safety protocols, regulations and standards.
- Developed strategies to improve operational efficiency and reduce costs.
- Monitored job progress to ensure quality standards were met.
Clinical Research Coordinator
MCB Clinical Research Centers
Colorado Springs, CO
10.2018 - 06.2021
- Compiled trial related documents into a master file as required by sponsor or regulatory agency.
- Assisted in preparing periodic reports summarizing progress of clinical studies.
- Developed and maintained accurate and timely study databases.
- Assisted in the preparation of Institutional Review Board submissions for clinical trials.
Research and Development Manager
Delta Waves
Colorado Springs, CO
07.2015 - 09.2018
- Conducted quality assurance reviews of study sites to ensure adherence to Good Clinical Practices.
- Developed and managed clinical research protocols, budgets, and project timelines.
- Collected, processed and delivered specimens from trial participants.
- Developed training materials for clinical research staff on GCPs, ICH guidelines, and other relevant topics.
- Coordinated the collection and analysis of safety data in accordance with FDA regulations.
- Ensured that all adverse events were reported promptly according to FDA regulations.
Education
Bachelor of Arts in Business Administration -
College of Alameda
05.2004
Bachelor of Science in Biological Sciences -
College of Alameda
05.2004
Associates Degree in Radiologic Technology and Psychology -
San Diego Community College
06.1992
Skills
- IMedidata
- Inform
- ECaselinks
- DSG
- Medrio
- Problem-Solving
- Regulatory Compliance
- Coaching and Mentoring
- Operations Management
- Business Development
- Hiring and Recruitment
- MS Office
- Multitasking and Organization
- Budgeting and Cost Savings
Rating Scales Experience
- Pediatric ADHD
- Schizophrenia
- Bipolar II
- Adult ADHD
- Type II Diabetes
- Ulcerative Colitis
- Crohn’s Disease
- Flu
- Allergic Rhinitis
- Gout
- PTSD
- Migraine
- Autism
- Pediatric Aggression
Certification
- CCRC, 06/2023
- IATA, 06/2023
- BLS, 06/2022
- GCP, 06/2023
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Quote
There is a powerful driving force inside every human being that, once unleashed, can make any vision, dream, or desire a reality.
Tony Robbins
Timeline
Research Site Manager
MCB Clinical Research Centers
07.2021 - 08.2023
Clinical Research Coordinator
MCB Clinical Research Centers
10.2018 - 06.2021
Research and Development Manager
Delta Waves
07.2015 - 09.2018
Bachelor of Arts in Business Administration -
College of Alameda
Bachelor of Science in Biological Sciences -
College of Alameda
Associates Degree in Radiologic Technology and Psychology -
San Diego Community College
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