Beverly Harris
Washington,DC
Summary
Versatile clinical research professional knowledgeable about coordinating patient information, laboratory samples and compliance documents for diverse clinical trials. Highly organized and thorough with good planning and problem-solving abilities. Areas of expertise include excellent communication skills, data review and entry. Experience in mental health nursing and utilization review. Clinical Researcher with 23 years experience with focus in research coordination and management. Monitored several MH studies including depression and schizophrenia. Certifications obtained through the Association of Clinical Research Associates ( ACRP) as both a research coordinator (CCRC) and research monitor (CCRA). Versatile clinical research professional knowledgeable about coordinating patient information, laboratory samples and compliance documents for diverse clinical trials. Highly organized and thorough with good planning and problem-solving abilities. Certified in Mental Health.
Overview
16
16
years of professional experience
1
1
Certification
Work History
Senior Clinical Research Coordinator
Alternative Solutions Lifeline
05.2017 - Current
- Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
- Collected data and followed research protocols, operations manuals, and case report form requirements.
- Active contributor in investigator/sponsor and coordinator meetings, sharing valuable study data and insight as requested.
- Maintained working knowledge of and ensured compliance with applicable GCP-ICH Guidelines, for local regulatory requirements, SOP, and study specific procedures. Monitor the progress of clinical studies,at investigative sites and remotely.
- Increased study engagement both with patients and site staff along with support study compliance requirements to meet sponsor goals.
- Maintenance of of study regulator document, including screening and enrollments logs,drug accountability logs, subject identification logs, site signature logs. Completion of case report forms (CRFs).
- Coordinate and oversee clinical assessments of clients participating in clinical trials studies of major hypertension, diabetes and congestion's heart failure.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
Senior Clinical Research Associate
Lockheed Martin
09.2012 - 05.2017
- Conducted independent research to validate efficacy of solutions, assimilate results and prepare written technical reports.
- Maintain open and ongoing communication about study status and volunteer visit status with site team members, e.g. lab personnel, volunteer support staff so that staff can plan their workday accordingly.
- Update and/or create SOPs, Work Instructions, or other documents, as assigned.
- Participate in meetings to include (pre-planning and clinical tracking).
- Ensure studies are documented and tracked,filed and maintained, and archived in audit-ready condition aided in the facilitators of study monitoring visits.
- Performed on-site facility inspections.
- Timely completion of data entry for all eCRFs, as well as paper CRF completions and transmissions.
- Generated and upload assay data and communicated results and reports to multi-disciplinary project teams to influence progression in discovery and development.
Lead Clinical Research Coordinator
National Institute Of Health
07.2008 - 05.2016
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol; compliance and data quality.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Liaised with clinical project leader to effectively resolve study-related issues.
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
- Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
- Followed informed consent processes and maintained records.
- Coordinated clinical trials focused on disorders such as Depression and Obsessive Compulsive Disorders.
Education
No Degree - Clinical Research Coordinator Certification
National Institutes Of Health
Rockville MD04.2024
Bachelor of Science - Health Sciences
Howard University
Washington, DC08.2005
Associate of Science - Pediatric Nursing
Straford University
02.2002
Skills
- Good Clinical Practices
- Research SOPs understanding
- Trial management
- Study protocols
- Analytical skills
- Interpersonal Communication
- Written Communication
- Flexible and Adaptable
- Detail-oriented
- Planning and Coordination
- MS Office
- Data Collection
- Protocol development
- Study monitoring
- Adverse event tracking
- Participant screening
- Trial oversight
- Informed consent
- Documentation requirements
- Dispensing oversight
- Phlebotomy
- Specimen collections
- Data Analysis
Certification
- Qualified Mental Healthcare Professional Training - 15 Years
- NIH Clinical Researcher Certification - 25 Years
- Association of Clinical Research Professionals Training - 15 Years
Timeline
Senior Clinical Research Coordinator
Alternative Solutions Lifeline
05.2017 - Current
Senior Clinical Research Associate
Lockheed Martin
09.2012 - 05.2017
Lead Clinical Research Coordinator
National Institute Of Health
07.2008 - 05.2016
Bachelor of Science - Health Sciences
Howard University
- Qualified Mental Healthcare Professional Training - 15 Years
- NIH Clinical Researcher Certification - 25 Years
- Association of Clinical Research Professionals Training - 15 Years
No Degree - Clinical Research Coordinator Certification
National Institutes Of Health
Associate of Science - Pediatric Nursing
Straford University
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