Karen Matthews
Norristown,PA
Overview
21
21
years of professional experience
2
2
years of post-secondary education
Work History
CLINICAL RESEARCH ASSOCIATE
ThermoFisher
Audubon, PA
05.2017 - 01.2025
- Ensured all research procedures were in compliance with regulatory standards and guidelines
- Conducted research on cardiovascular diseases and contributed to the development of new treatment options
- Managed clinical trials for drug efficacy testing on diabetic patients
- Coordinated with study sponsors to ensure smooth execution of clinical trials
- Developed and maintained databases to track patient records and study results
- Provided mentorship and training to junior research staff on study protocols and data collection techniques
- Performed site evaluations and initiated site visits to ensure proper study conduct and participant safety
- Presented findings at clinical research conferences, effectively communicating complex data to diverse audiences
- Monitored trial progress by conducting regular site visits and providing support to clinical staff
- Maintained accurate and organized documentation in accordance with Good Clinical Practice (GCP) guidelines
- Trained and mentored new clinical research staff on study protocols and regulatory compliance
PHLEBOTOMIST
Quest Diagnostics
King Of Prussia, PA
04.2016 - 04.2017
- Maintained accurate patient records and lab results while adhering to HIPAA regulations
- Performed venipuncture and capillary collection on patients, ensuring safety and comfort
- Collaborated with healthcare team members to improve patient care and streamline processes
- Trained new staff on blood collection techniques and equipment usage
CLINICAL RESEARCH COORDINATOR
PMA Medical
Collegeville, PA
01.2010 - 03.2017
- Coordinated and managed multiple clinical trials adhering to FDA regulations and Good Clinical Practice guidelines
- Developed and implemented study protocols in collaboration with investigators and sponsors
- Monitored patient recruitment and retention strategies to optimize clinical trial enrollment
- Conducted training sessions for site staff on study procedures and regulatory compliance
- Facilitated communication between investigators, patients, and sponsors to streamline clinical trial operations
- Analyzed trial data and prepared comprehensive reports for stakeholders to support decision-making
- Liaised with regulatory authorities to secure necessary approvals and maintain compliance throughout the study
- Collected and managed clinical data, ensuring accuracy and integrity throughout the trial process
INTERPRETER BILLING CLERK/ SIGN LANGUAGE INTERPRETER
Communication Connection
Norristown, PA
05.2004 - 04.2007
- I would collect the interpreters billing information and input it into Quick books System
- I would go out on appointments to provide clients who are deaf or hard of hearing sign language services
Timeline
CLINICAL RESEARCH ASSOCIATE
ThermoFisher
05.2017 - 01.2025
PHLEBOTOMIST
Quest Diagnostics
04.2016 - 04.2017
CLINICAL RESEARCH COORDINATOR
PMA Medical
01.2010 - 03.2017
Associate of Science - Allied Health
Lansdale School of Business
01.2005 - 05.2007
INTERPRETER BILLING CLERK/ SIGN LANGUAGE INTERPRETER
Communication Connection
05.2004 - 04.2007
Summary
Accomplished Clinical Research Associate with 9 years of experience performing and documenting pre-study site evaluations, regulatory document collection, interim monitoring and study close-out visits. Diligent in performing studies aligned with good clinical practices, study-specific requirements and clinical monitoring plans. In-depth knowledge of company procedures, regulatory requirements and quality standards. Detail-oriented Clinical Research Associate well-versed in coordinating operations, managing sites and drafting detailed clinical reports. Knowledgeable about action planning, database locking and standard operating procedures. Supports participant recruitment and management to meet research objectives. Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Education
Associate of Science - Allied Health
Lansdale School of Business
Phoenixville, PA 01.2005 - 05.2007
Skills
- Study design
- Data evaluation
- Patient recruitment strategies
- Good clinical practice
- Site management
- Protocol development
- Data collection
- Protocol adherence
- Team Training
- Patient safety
- Completing regulatory documents
- Clinical documentation
- Research and development
Certification
- Good Clinical Practice (GCP) Certification - Various Providers.
- Lean Six Sigma Green Belt Certification – Various Providers.
- Certified Clinical Research Coordinator (CCRC) - Association of Clinical Research Professionals.
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Languages
English
Native language