Quality Control Data

Jill Robinson

Clinical Research Associate III - Aptiv Solutions

Franklin, TN

******@*********.*** - 859-***-****

Certified clinical research professional qualified by over 11 years of broad clinical research experience, most

recently as a Clinical Data Coordinator within the Covance Clinical Data Management department. Initial

experience was as a coordinator working in a large university medical centre hospital within their department of

surgery. Experience includes data management, coordinating, monitoring and patient recruitment positions in

phases II and III clinical research in several multi-national studies to include VA Cooperative studies. Worked

on device and drug studies (vascular disease, critical care, diabetes, ulcerative colitis, oncology and veno-

occlusive disease associated with stem cell transplants) with the most recent concentration in cardiology

research. Worked in both academic and private sectors. Ensures patient confidentiality and highest levels of

professionalism throughout process. Team player dedicated to quality and continuous improvement.

WORK EXPERIENCE

Clinical Research Associate III

Aptiv Solutions - August 2012 to Present

Clinical Data Coordinator

COVANCE, INC - January 2010 to May 2012

Review clinical trial data in accordance with [Global] Data Management Plans and applicable standardized

data management processes (SOPs, Work Instructions, etc.) to identify erroneous, missing, incomplete, or

implausible data.

• Run ancillary programs (e.g., diagnostics, special listings, reconciliation discrepancy listings) used to support

the review of clinical trial data.

• Generate, resolve and track queries to address problematic data identified during data review activities and

apply proper modification / correction to the database.

• Apply quality control procedures and checks to ensure data quality standards (client and Covance) are

achieved.

• Interact with the dictionary coding and maintenance group to ensure appropriate process set-up and

application.

• Assist with the reconciliation of central laboratory and/or third party vendor data. (eCRF, eDiary, specialty

laboratory, etc.)

• Assist with the aggregate review of clinical data by patient, site, and/or project to identify data trends (patient

safety, compliance, etc.), and/or data inconsistencies that require further investigation.

• Assist in the development and testing of data management system edit / data validation checks (diagnostics)

and special listings / procedures used as tools for the data review and discrepancy management activities.

• Support the training of project staff on project-specific, global, standardized data management processes.

JILL ANNE ROBINSON, M.T., ASCP, CRC, ACRP

4408 Savage Pointe Drive • Franklin, TN 37064

615-***-**** • Cell: 859-***-**** • ******@*********.***

Clinical Research Coordinator, Home-Based

QUINTILES, INC - March 2008 to October 2009

Worked directly at patient/subject interface as an integral member of the partner investigational site to deliver

high quality patient data in accordance with the protocol, contracted scope of work, ICH/GCP, Sponsor/CRO

SOP's and any relevant local guidelines and all regulations.

• Participated in the screening and recruitment of research participants.

• Designed and maintained organizational tools to conduct the research study accurately in compliance with

Good Clinical Practice (GCP) guidelines.

• Attended and participated in investigator meetings, seminars and other regional or national research

meetings.

• Participated in study monitor and audit visits.

• Assisted investigators in obtaining proper written consent from patients according to FDA guidelines.

• Performed functions necessary for completion of all research protocols including scheduling, patient

enrollment, medical histories, clinical assessments, laboratory phlebotomy and processing, IATA compliant

shipping, diagnostic studies, dispensing of investigational medication and overall organization and logistics

of study visits.

• Completed and corrected case report forms (CRFs) ensuring accuracy of all records connected with each

research patient.

• Reported and recorded all adverse events according to GCP-FDA guidelines and the request of the sponsor.

• Maintained accurate record of all study supplies including lab kits, medications, and other items that may

be dispensed to the patient.

Contract Regional Coordinating Clinical Research Associate (CRA)

CLINFORCE, LLC - Research Triangle Park, NC - July 2007 to November 2007

Completed all required CRA training and in-house activities prior to study assignment for study indication of

severe veno-occlusive disease in hematopoietic stem cell transplant patients for greater than 10 sites.

• Managed assigned investigational study sites to ensure adherence to Good Clinical Practices (GCPs), SOPs

and study protocols.

• Reviewed all documents as required and prepared site monitoring visit reports in a timely manner for each

study visit.

• Maintained all files and documentation pertaining to assigned study sites.

Clinical Research Associate, Monitor

ICON CLINICAL RESEARCH - Brentwood, TN - September 2006 to June 2007

Project experience included multiple therapeutic indications to include, ulcerative colitis and chronic insomnia.

• Completed•all required CRA training and in-house activities prior to study assignment•

• Managed assigned investigational study sites including: interim monitoring and closeout visits to ensure

adherence to Good Clinical Practices (GCPs), SOPs and study protocols.

• Reviewed regulatory documents as required and prepare site monitoring visit reports in a timely manner for

each

study visit.

• Maintained all files and documentation pertaining to assigned study sites.

Patient Recruitment Coordinator

PRAXIS - Brentwood, TN - 2005 to 2006

Coordinated and implemented patient recruitment initiatives to include:

• Developed, maintained and updated databases for effective management of patient recruitment plans

throughout the study.

• Coordinated all aspects of the daily operations of the recruitment/awareness and retention programs

assigned.

• Maintained data, developed and presented client progress and status reports and final summary.

• Conducted community level research for support groups and organizations specializing in the targeted patient

population.

• Supported and participated in corporate and department initiatives regarding quality system implementation,

maintenance, and continuous quality improvement activities.

• Coordinated with client, call center, advertising agency, webmaster and other vendors in execution of

recruitment plan according to timeline.

JILL ANNE ROBINSON, M.T., ASCP, CRC, ACRP

4408 Savage Pointe Drive • Franklin, TN 37064

615-***-**** • Cell: 859-***-**** • ******@*********.***

Clinical Research Coordinator

UNIVERSITY OF KENTUCKY - 2003 to 2005

Proficient in the following areas of clinical research:

• Coordinated and organized studies including maintaining and developing source documents, completing

case report forms, and managing research data.

• Recruited and screened patients for enrollment and obtained/informed consent/HIPAA.

• Managed patient follow-up and sponsor relations.

• Knowledge of Food and Drug Administration, International Council on Harmonization, and Good Clinical

Practice guidelines.

• Working knowledge of regulatory (institutional review board), budget management, and serious adverse

event and adverse event reporting.

UNIVERSITY OF KENTUCKY - Lexington, KY - 1995 to 2005

Research Analyst

UNIVERSITY OF KENTUCKY - 2001 to 2003

Conducted pre-clinical investigation of multi-drug resistance (MDR) in treatment of various thyroid carcinomas.

• Profiled genetics of MDR genes in anaplastic thyroid carcinomas and isolated RNA by Trizol Method.

• Conducted sterile primary-tissue and cell culture (antibiotic free), CDNA synthesis, and RT-PCR.

• Conducted protein isolation and western blot techniques.

• Conducted clinical blood dosimetry, cell survival and drug toxicity, MTT, and Cytotoxicity assays.

Medical Technologist

UNIVERSITY OF KENTUCKY - 1997 to 2001

Conducted clinical assays in serology, flow cytometry and molecular diagnostics, as well as performing clerical

and administrative support duties.

• Phenotyped human leukocyte antigens utilizing polymerase chain reaction and serological techniques.

• Identified human leukocyte antigen antibodies by microcytotoxicity and flow cytometry.

• Identified molecular mutations through DNA-based testing.

• Cross-matched solid organ and bone marrow transplantation by microcytotoxicity and flow cytometry.

• Phenotyped cells by flow cytometry for diagnosis and prognosis of leukemia and lymphoma.

• Used flow cytometry to count CD4 and CD8 for immunocompromised patients.

• Conducted cell culture based lymphocyte response studies.

• On-call for regional donor human leukocyte antigen typing and STAT cross matches for KODA.

• Maintained patient records for cross match procedures while also maintaining patient confidentiality.

• Participated in continuing education and proficiency testing and taught visiting medical technology students.

• Billed clinical procedures to patient accounts and maintained laboratory supplies and inventory.

Medical Technologist

UNIVERSITY OF KENTUCKY - 1995 to 1997

Conducted clinical assays on patient specimen and quality control assays.

• Completed blood counts, differentials, and coagulation assays.

• Performed spinal fluid analysis and urinalysis.

Clinical Laboratory Technologist

UNIVERSITY OF KENTUCKY - Lexington, KY - 1995 to 1995

Processed and tested routine specimens in hematology and clinical chemistry. Performed quality control

testing.

• Completed blood counts, differentials, and coagulation studies.

• Conducted urinalysis and complete chemistry profiling.

EDUCATION

Bachelor of Health Science in Clinical Laboratory Science

University of Kentucky in Lexington - Lexington, KY

Bachelor of Science in Animal Science

University of Kentucky in Lexington - Lexington, KY

ADDITIONAL INFORMATION

COMPUTER SKILLS

Technically proficient with Microsoft Office products including Word, Excel, and PowerPoint. Electonic Data

Capture (EDC) experience (Medidata Rave 5.6.2 and Phase Forward Inform CDM IOL Version 4.6).

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