Results-driven Research Quality & Compliance Auditor with solid quality assurance and regulatory affairs experience in clinical research. Detailed-oriented professional with excellent organizational, analytical and communication skills demonstrated with over eleven years in clinical oncology. Proven ability to manage multiple projects and meet critical deadlines. Strengths include solid communication and problem solving skills and adapting to change.
Quality assurance standards
Electronic data capture systems
SOP development and implementation
Strong presentation skills
Strong knowledge of FDA/ICH GCP's
Work well independently
Research process and Analysis
Extensive Organizational Skills
Analytical software (SAS/SPSS)
ICD-9 coding experience
Maintained compliance with regulatory standards by training regulatory and investigative site staff on process improvement and new FDA guidance.
Assisted in implementation of new tracking system that resulted in improved investigative site staff query resolution.
Research Quality & Compliance Auditor January 2012 to CurrentUS Oncology/McKesson Specialty Health － The Woodlands, TX
Effectively plan and conduct regular and random QA audits (internal and external) in order to assure that clinical studies managed by USON are of the highest standard and are in compliance with the requirements of USON or Sponsor SOPs, study protocols, relevant regulations and guidelines.
Ensure that audit results are formally recorded and reported and that corrective/preventive actions are documented.
Assist in training USON staff regarding GCP.
Audits study protocols for compliance with GCPs and departmental SOPs.
Conducts standard research site audits for adherence to GCP, ICH and FDA regulatory requirements and regularly scheduled visits to audit for timeliness and quality of clinical research data.
Monitors compliance with written research operating procedures at assigned practice sites through review and audit of patient lists.
Monitors data on investigator-initiated trials.
Validates raw data from patient charts and audits for accuracy.
Audits case record to determine if tests are completed in accordance with protocols.
Audits information on CRF to ensure consistency with medical records.
Reviews site audit reports with practice-based research staff and administration and works collaboratively with Network Research Operations Managers to affect action plans.
Completes and submits written research QA site audit reports to central Quality Management and Compliance Coordinator on a monthly basis.
Develops and implements corporate-wide research QA programs at site locations.
Works with sites to assist with the development of internal QA programs.
Responsible for new research site qualification with respect to company research policies and procedures.
January 2005 to January 2012MD Anderson Cancer Center － Houston, TX
Human Research Regulations Specialist January 2008 to January 2012MD Anderson Cancer Center － Houston, TX
Provides clinical trial monitoring and follows established monitoring processes to support compliance with applicable regulations.
Coordinates all Institutional Review Board (IRB) and regulatory affairs activities related to the clinical research conducted within MDACC.
Oversees the Submission of protocol amendments, informed consents, continuing reviews and protocol deviations/exceptions and adverse events for IRB.
Implements research quality improvement and educational efforts to enhance awareness of investigators' and administrative staffs' knowledge of the regulations governing human subjects protection.
Conducts a variety of monitoring and training activities intended to facilitate and assure that protocols are in compliance with the requirements of the approved study protocol, the approving Institutional Review Board/Ethics Committee, and applicable Food and Drug Administration (FDA) requirements.
Coordinates and evaluates the accuracy of institutional clinical trials.
Collaborates with physicians, mid-level providers and Sr.
Research Nurse to document and perform protocol-specific tasks to ensure the accuracy of human subject protection.
Provides individual department in-services to assist departments with specific research concerns.
Develops appropriate Standard Operating Procedures (SOPs).
Strong knowledge of federal and state regulations and institutional guidelines for the protection of human subjects.
Verify that all internal protocol is performed according to International Commission on Harmonization (ICH) standards Good Clinical Practices (GCP) and the sponsor's or Contract Research Organizations (CRO) Standard Operating Procedures (SOPs).
Reviews records and procedures concerning interactions with the IRB.
Verify compliance with internal SOPs.
Audits internal study documentation for compliance and accuracy.
Reviews final study analysis for publication and termination.
Clinical Research Data Coordinator January 2005 to January 2008MD Anderson Cancer Center － Houston, TX
Independently manages significant and key aspects of more than one clinical trial.
Supports clinical research activity through development of protocol-specific documents and reports for effective and compliant clinical research protocol activity from initial submission through study closure.
Trains and provides guidance to less experienced staff.
Oversees data management for research projects.
Identifies, tracks, and reports Adverse Events.
Interfaces with research participants and resolves issues related to study protocols.
Determines effective strategies for promoting/recruiting research participants and retaining participants in long term clinical trials.
Collects study specific regulatory documents (Form 1572, financial disclosure forms, and protocol signature pages) from participating research sites.
Provides leadership in identifying and implementing corrective actions/processes.
Monitors IRB submissions and responds to requests and questions.
Maintains and updates IRB interim reports.
Interfaces with study sponsors, monitors and reports AE's, SAEs and resolves study queries.
Provides leadership in determining, recommending, and implementing improvements to policies/processes.
Coordinates and gathers patient data for research studies.
Participate in oncology research Phase I-IV study data management.
Coordinates, reviews and inputs protocol data in databases such as: CRF, EDC-Data Trak and PDMS.
Prepares data for audits, monitoring, analysis, and presentations.
Coordination of regulatory correspondence on clinical research trials.
Communicates verbally and in writing with internal reviewers and external agencies.
Assist in the process of identifying eligible patients for clinical study protocol.
Updating regulatory document binder for sponsor review and monitoring.
Attends site initial meetings and as well as working closely with investigator and nurse to ensure proper progression of study protocol.
Prepares and manages data spreadsheets and database for sponsor and monitor weekly review.
Education and Training
Bachelor of art : Psychology & ChristianityHouston Baptist University － Houston, TXPsychology & Christianity
Master of art : PsychologyCapella University － Minneapolis, MNPsychology Evaluation, Research and Measurements
Certified Clinical Research Professional (CCRP)
administrative, audit reports, binder, charts, clinical research, clinical study, clinical trials, Critical Thinking, Client relations, Data entry, data management, databases, database, Documentation, Staff Training, financial, forms, GCP, ICD-9, leadership, Regulatory compliance, meetings, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Works, Monitors, Network, oncology, Organizational Skills, policies, presentations, presentation skills, processes, Process improvement, coding, protocols, publication, quality, quality improvement, Quality Management, QA, Quality assurance, recruiting, regulatory affairs, regulatory documents, Research, SAS, SOP, spreadsheets, SPSS, Statistical analysis, Team player, Verbal Communication, Written