Clinical Research Quality Assurance

**** ***** ****

San Antonio, TX *****

Phone 210-***-****

Cell 210-***-****

E-mail *****.*******@***.***

Diana Jarbeau-May

Objective

To pursue a career opportunity in the field of research where commitment to excellence will allow for professional growth in which I can help to enhance program development efforts and impact profitability.

PROFESSIONAL EXPERIENCE

Clinical Research Coordinator II Texas Liver Institute

January 2015- Present San Antonio, Texas 78215

Assists in preparation of all documents related to the informed consent and assist with the consent process.

Reviews and develops a familiarity with the protocol, study proceedings and timelines, to include but not limited to Inclusion/Exclusion criteria, confidentiality and privacy protections.

Establishes and organizes study files, including but not limited to regulatory binders and study specific source documentation.

Screens subjects for eligibility using protocol specific inclusion/exclusion criteria.

Collects data as required by the protocol and assures timely completion of case report forms.

Maintains effective and ongoing communication with sponsor, research participants and PI during the course of the study.

Quality Assurance Coordinator Deer Oaks a Behavioral Health Organization

September 2014- December 2014 San Antonio, Texas 78240

The Quality Assurance Coordinator serves as the administrative an operational lead of the Quality Assurance Department and works collaboratively with the Chief Operations Officer to provide oversight of the following tasks:

Works closely with clinicians to collect clinical data for the purpose of submitting provider Audits to the Center for Medicare (CMS)

Assist In collection of clinical documents for the purpose of Improper payment rate through Comprehensive Error Rate testing (CERT)

Assist the Director of Quality Assurance in training of new clinicians

Acts as a liaison to senior leadership in HR and IT Operations

Consistently monitors and reviews new clinicians performance feedback from Regional Directors for purpose of peer review.

Assistant Clinical Research Coordinator Worldwide Clinical Trials

May 2013- January 2014 San Antonio, Texas 78217

Reviews study protocol and Investigator’s Brochure for studies they will be assigned to

Prepares study source documents. During involvement in trial, helps assure source documents for the trial are accurate and thorough.

Performs quality checks on source documents specific to the study.

Communicates with recruitment services and clinic staff regarding recruitment status for assigned studies

Responsible for the clinical lab report process (Investigator assessment, repeats if necessary and filing).

Cover subject visits (i.e. outpatient visits, check-ins, check-outs, and dose qualifications) as assigned.

Obtains and documents adverse event data on appropriate forms.

Communicates with Documentation and Compliance and Quality Assurance for query resolution through the study process.

Completes CRF’s. Enters data into CRF using 100% source documentation verification.

Quality and Patient Safety Coordinator Christus Santa Rosa Health System

Nov. 2012-March 2013 San Antonio, Texas 78207

Knowledge of risk management, peer review, HIPAA and patient safety

Knowledge of external regulatory bodies and ability to respond to inquiries/investigations

Ability to communicate with staff, medical staff, EMG, and the community as a champion for safe, effective care.

Responsible for reviewing of medical records and abstracting

Ability to ensure the confidentiality and rights of all patient, health system and departmental documents.

Ability to conduct and lead meetings.

Ability to analyze data and use management techniques and statistical tools to obtain maximum effectiveness, efficiency and information

Advanced knowledge of clinical protocols and practice management requirements

Knowledge of Joint Commission Standards and Clinical Guidelines.

Clinical Research Coordinator Cancer Care Centers of South Texas

Nov. 2009- Sept. 2012 San Antonio, Texas 78217

Responsible for conducting clinical trials according to FDA regulations and guidelines.

Obtain written informed consent from all study patients.

Educates patients about the research protocol.

Report any adverse or serious adverse events to all responsible parties, knowledge of disease index and pathology reports

Extrapolates data, completes manual Case Report Forms, and ensures timely data submissions in accordance with USOR SOP.

Actively schedules, prepares for and participates in monitoring and auditing activities.

Attend Investigator’s meetings, Site qualification meetings, Site Initiation Visits, and Closeout Visits as appropriate per protocols

Responsible with screening patients for potential study enrollment according to FDA regulations and guidelines

Act as a Liaison for site research leader, and actively communicates with sponsors and project managers.

Responsible for assisting with collection and processing of specimens, imaging documents or other items required for research purposes.

Responsible for assisting with the investigational drug accountability process.

May lead and mentor other data coordinators, and clinical study coordinators.

Execute other duties as may be required by upper management

Data Coordinator/Regulatory Coordinator Cancer Care Centers of South Texas

March 2008-Nov 20009 San Antonio, Texas 78217

I assure quality and completeness of source documents, case report forms, and update of the eDC trails documents system.

Establishes study document binder to maintain complete and accurate records all sponsor, site, CRO, IRB/IEC correspondence and regulatory documents pertaining to the study.

Assists Quality Assurance manager with shipping of clinical supplies.

Reviews technical and clinical documents for accuracy and conformances with existing regulatory approvals and new product registrations.

Maintains research records in a confidential manner according to practice policies, sponsor confidentiality agreements, HIPAA guidelines and any other applicable regulations

Composing and organized regulatory submissions for oncology products in Phase I-IV development, ensuring compliance with current federal regulations, GCP and ICH guidelines

Maintains quality affairs database

Ensures proper routing of change control folders and ensures that the proper individuals receive and sign documents.

Provides product information to Medical and Regulatory Affairs departments to be used in reports for FDA

Assoc. Clinical Data Analyst/Sr. Med Data Operator ILEX Oncology, Inc./Genzyme Corp.

December 1999 – March 2008 San Antonio, Texas

Review Case Report Forms (CRFs) generated from clinical trials for completeness and accuracy using Edits, CRF listings, manual review and other appropriate guidelines.

Generate Data Clarification Forms (DCFs) if data is incomplete, unclear, or discrepant according to the validation specifications of the Data Management Plan (DMP).

Update the database & CRFs as a result of answered DCFs, patient profiles or edit reports.

Perform secondary and auxiliary data review, e.g. central lab data, diary data, SAE reconciliation.

QC database listings vs. source documents

Assist with database closure activities.

Write and review Data Management Plans and other key study documents.

Manage the clinical data management process for studies.

Liaise with clients and produce study progress reports.

Performing routine data file uploads and transfers between computers as needed by a study, and setting up files.

Create, review, and process Data Clarification Forms and updates the databases.

Forms (CRF's) into database(s) using appropriate software.

Responsible for creating and distributed ad-hoc report/ summaries to clinical researchers.

Reviews and analyzes clinical data to ensure consistency, integrity and accuracy using project specific guidelines.

EDUCATION

Bachelor of Business Administration University of Incarnate Word

Major: Psychology of Organization and Development San Antonio, Texas (USA)

2005 – 2007

General studies North West Vista College

2002-2005

TECHNICAL EXPERIENCE

Oracle Clinical, ClinTrial, Medidata, Rave Clinical, InForm, CTMS and IVRS

Electronic Medical Records (iKnowmed)

Windows OS (95 – XP Pro), Microsoft Word, Excel, Access, Outlook, PowerPoint, Adobe Professional, (Nuance) Oracle databases,

Meditech,

SUMMARY OF QUALIFICATIONS

Enthusiastic and experienced in areas of adaptability.

Maintains clinical databases to support Phase I, II, and III study trials using standard database designs.

Skilled at learning new concepts quickly, working well under pressure, and communicating ideas clearly and effectively.

Reviews and analyzes clinical data to ensure consistency, integrity and accuracy using project specific and GCP guidelines.

Assure that the integrity and quality of the clinical research trial is maintained and that the trial is conducted in accordance with Good Clinical Practice guidelines.

Responsible for proper submission of Regulatory documents to New England Institutional Review Board, National Cancer Institute, and Copernicus Group IRB.

CRP certified, IATA trained, Human subject protection

Bilingual (English/Spanish)

Fifteen years’ experience in Clinical Research; thirteen years in Oncology

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