Clinical Research Associate Ii resume example with 10+ years of experience
JessicaClaire
, , 609 Johnson Ave., 49204, Tulsa, OK100 Montgomery St. 10th Floor
Home: (555) 432-1000
Cell:
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Summary
CLINICAL RESEARCH ASSOCIATE CAREER PROFILE Highly motivated and results-driven clinical research associate with over 9 years of professional experience in clinical research, proven track record in developing and implementing cutting-edge methodologies to conduct clinical research and execute out functional procedures. Specialized in Cardiovascular, Endocrinology, and CNS Neurology therapeutic investigations in Phase I, II, and III studies, with strict adherence to ICH-CGP guidelines. Strong background in implementing Standard Operating Procedures, Good Clinical Practices, safety management strategies to work, and overseeing various areas of clinical protocols and clinical trials in order to ensure personal, organizational, and community safety. Executing daily tasks such as enrollment, scheduling, training of staff, audits, data entry, and submission of IRB paperwork. Relationship-building individual with excellent leadership, interpersonal, and organizational abilities. Seeking a position where my skills will be fully utilized for clinical research and medical advancement.
Skills
Site Management
Research Protocols
Specimen Preparation
SOPs Implementation
Project Management
Data Collection & Analysis
Problem Resolution
Clinical Trail Monitoring
Clinical Research Methodology
Good Clinical Practices (GCPs)
Emergency Procedures
Organizational Skills
Team Player
Multitasker Indiviual
Instrumentation Care & Calibration
Risk Assessment
Clinical Trial Management Systems (CTMS)
Serious Adverse Event (SAE) Reporting
Regulatory Compliance
Experiment Documentation
Interpersonal Communication
SUMMARY OF CORE QUALIFICATIONS
Proficient in using Microsoft Word, Microsoft Excel, Microsoft PowerPoint, EDC/ECRF software as per guidelines.
Incredible knowledge of FDA and local regulatory requirements, like GCP, ICH guidelines, Serious Adverse Event (SAE)
Reporting, Institutional Biosafety Committee guidelines and systems for clinical trial management.
Good understanding of appropriate therapeutic indications in clinical trials, diagnose and application of SOPS and
Necessary Clinical Practices.
Capacity to conduct pre-study visits, consult with the investigators about the protocol, other relevant study
Documentation in order to ensure site staff are compliance with protocol necessities.
Capability of monitoring clinical research protocols for vaccines and drugs, human and animal research sites, disposal
Techniques for hazardous materials. Ability to understand and extract information from medical records.
Self-motivation and ability to work independently with strong problem-solving and organizational abilities, as well as
Strong written and spoken communication skills.
Experience
Clinical Research Associate II, 02/2020 to Current Dermtech, Inc. – Tampa, FL,
Making suggestions for site-specific activities, carrying out plans to deal with problems with project team, advising site employees on methods to deal with issues swiftly
Attending clinical training sessions
Maintains a working understanding of the ICH/GCP Guidelines, pertinent laws, and company SOPs, site initiation, interval monitoring, site management activities, and close-out visits
Verifies required clinical data entered in the case report form (CRF) is accurate and verifies permissions, trains staff in protecting the confidentiality of patients and accessing factors that affect clinical data integrity
Utilizes available methods to enable the efficient assessment of clinical research data, confirms site compliance with
EDA requirements, maintains medical records, and keeps track of site management plans (SMPs)
Performs an inventory of investigational products (IP), reconciliation, and assessments of storage and security
Verifies
IP administered methods and duties, and hazards related to blinded information
Entering data into tracking systems to capture all observations, continuing status, and assigns action items to resolution supports and awareness techniques
Ensures that all assigned sites and project-specific site team members are properly trained and compliance with all regulations, while also keeping an eye on budgets and protocols
Providing audit readiness standards guidance at the site and project level, as well as supporting for audit preparation.
Clinical Research Associate II, 01/2018 to 12/2020 Dermtech, Inc. – San Diego, CA,
Reviewed clinical data queries, listings, site regulatory files, case report forms and collaborated with study centers to resolve data discrepancies
Liaised with clinical investigator and project leader to identify, assess, and address study-related, site performance, quality, and compliance issues
Planned and coordinated protocol-related site visits and necessary testing to show attentiveness in patient safety, protocol compliance, and data quality.
Clinical Research Associate, 09/2015 to 01/2019 Align Technology – Morrisville, PA,
Consulted with medical professionals to get directives and intervention protocols for patient care concerns
Complied with regulatory standards, operating procedures, and acceptable clinical practices
Executed pre-study, closeout, and interim visits to assess study activities
Supported quality control programs by planning site assessment visits after site permissions and key project documentation and by carrying out monitoring visits.
Clinical Trial Coordinator, 02/2012 to 08/2015 Cognizant Technology Solutions – Dearborn Heights, MI,
Followed protocols governing patient care and clinical trial operations while collecting and screening patient records, databases, case reports, and physician referrals to find potential research study participants
Contributed in facilitating daily trial activities and adhered to study protocols while collaborating with the main investigator and sponsors.
Education and Training
Master of Arts: Human Resources Development, Expected in 06/2020 Bowie State University - Bowie, MD GPA:
Master of Science: Public Health, Expected in 10/2010 University of Nigeria - , GPA:
Bachelor of Science: Biomedical Sciences, Expected in 08/2008 University of Nigeria - , GPA:
Project Management Professional (PMP): , Expected in 01/2001 - , GPA:
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