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Clinical Research Data

Location:
La Mesa, California, United States
Salary:
64,000.00
Posted:
October 15, 2016

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Resume:

Barbara Ivers, AA, CCRP, RCP, CRTT, CPFT

***** ****** ***, ********, ** 82040

Cell 626-***-**** Email: acw2kq@r.postjobfree.com

EXPERIENCE

*/****-******* ******** ******** Coordinator III /CCRP/CRA/RCP/CPFT: Clinical Trials Office

UCSD Moores Cancer Center LaJolla, California

Responsible for completion, registration and submission of data; monitor study compliance and maintains a system for effective data flow associated with research protocols.

Play active role in recruitment of patients to study

Ability to function independently with no quality control audits besides one yearly audit

Maintain professional growth and development through seminars, workshops, and professional affiliations to maintain certification / licensure, and / or keep abreast of latest trends in field of expertise

Work with physician or nurse to see that protocol related tests are ordered per protocol guidelines

Collect and deliver specimens for analysis, RCRF internally as well as study sponsor specific paper & electronic entry

Specific diseases: CLL

7/2008-3-2015 Clinical Research Coordinator III /CCRP/CRA/RCP/CPFT: Clinical Trials Office

Karmanos Cancer Institute Detroit Michigan

Research support position, provide assistance to Karmanos faculty membership who are conducting cancer-related Phase I clinical trials. Coordinate all regulatory data management aspects of Phase 1clinical trials. Bullets below list job duties:

Completing initial packets that sponsors send prior initiation of the study including but not limited to FDA 1572, membership listing, initial submission of new protocols to the IRB, etc.

Oncore electronic data systems input and assist with trouble shooting (cont education as the system is developed to hold all clinical trials data at KCI)

Once the study is open to accrual, responsibilities include completing and submitting any changes to the consent, protocol the IRB/HIC (Human Investigation Committee) and coordinating regulatory affiliates & sponsors.

Monitoring of compliance of internal & external regulations in the conduct of the clinical trials

Maintain a system for perpetration of effective quality of data flow

Reporting of serious adverse events, drafting consents, completing all documents for submission to the IRB for initial application, amendments, revisions, and responding to queries and annual renewals.

Maintain and update data base with current protocols, consent and any other essential documents for the clinical trails staff in order to provide the participants with proper documents to enroll in clinical trials

Multidisciplinary team efforts to run a phase 1 program 11/2010-10/2012 Respiratory Care Practitioner /RCP, CRTT, CPFT Beaumont Hospital Grosse Pointe, Michigan

All respiratory therapy duties in this active community hosp. respiratory floor care, CCU, ER,, recovery room, ventilators 02/2008-2010 Respiratory Care Practitioner /RCP, CRTT, CPFT STAT Staffing Solution, Inc. Farmington Hills, Michigan

Registry Position working at various hospitals in the community doing respiratory floor care as well as tracheotomy care and home vents, CPAP/BIPAP. Per diem position on weekends only. 1/2008–7/2008 Regulatory Specialist /CCRP /CRA/ RCP: Clinical Trials Office William Beaumont Hospital Royal Oak Michigan

Research support position; provide assistance to Beaumont faculty membership who are conducting cancer-related Phase II & III clinical trials. Coordinate all regulatory data management aspects of the clinical trials. Bullets below list job duties:

Completing initial packets that sponsors send prior initiation of the study including but not limited to FDA 1572, membership listing, initial submission of new protocols to the IRB, etc.

Once the study is open to accrual, responsibilities include completing and submitting any changes to the consent, protocol to the IRB/HIC (Human Investigation Committee) and coordinating regulatory affiliates & sponsors.

Monitoring of compliance to internal & external regulations in the conduct of the clinical trials

Maintain a system for perpetration of effective quality of data flow

Reporting of serious adverse events, drafting consents, completing all documents for submission to the HIC (Human Investigation Committee) for initial application, amendments, revisions, and responding to queries and annual renewals.

Maintain and update data base with current protocols, consent and any other essential documents for the clinical trails staff in order to provide the participants with proper documents to enroll in clinical trials 9/2002-10/07 Adverse Event Specialist /CCRP/ CRA/ RCP: Office of Clinical Research Quality Assurance (OCRQA) City of Hope Medical Center Duarte, CA

Review, Monitor and Process all Serious Adverse Event reports for City of Hope Clinical Trial Office (DSMB) (this includes COH IND studies) for completeness, accuracy and timeliness (GCP).

Attended weekly Hematology/BMT conference approved for Category I from the ACCME (2001 to 2006)

Review, Monitor and Process all Adverse Events/Serious Adverse Event and Safety Reports from Pharmaceutical studies, Co- operative group studies, Consortiums studies (phase one) conducted at City of Hope for completeness, accuracy, and timeliness (GCP)

Educated personnel (CRA, secretaries, PI.) with the interpretation of FDA, NCI and IRB requirements.

Educate staff for proper completion of City of Hope Adverse Event/Serious Adverse Event Reports.

Attend IRB (Internal Review Board), DSMB (Data and Safety Monitoring Committee) Meetings

Facilitate & develop an Access Database for cumulative SAEs on clinical trials

Develop Reports for appropriate committees, Medical Executive Committee (MEC), Internal Review Board (IRB), Data & Safety Monitoring (DSMB)

Facilitate the development and implementation of electronic submission of expedited serious adverse events.

Facilitate & provide education for the implementation of the electronic submission of expedited serious adverse events (CRA, PI, Secretaries, GCRC staff, all campus staff)

3/2007-2008 Respiratory Care Practitioner/ RCP

Professional Respiratory Network (PRN) South Pasadena, CA.

Registry Position working at various hospitals in the community doing respiratory floor care as well as trach care and home vents. Per diem position on weekends only

8/2002-2006 Respiratory Care Practitioner/ RCP

Associated Health Professional Inc., Culver City, CA.

Registry Position working at various hospitals in the community doing respiratory floor care as well as trach care and home vents. Per diem position on weekends only

3/2004-2006 Respiratory Care Practitioner/ RCP

Soliant Heath Long Beach, CA.

Registry Position working at various hospitals in the community doing respiratory floor care as well as trach care and home vents. Per diem position on weekends only

1/1999-2002 CLINICAL RESEARCH ASSOCIATE/ RCP

City of Hope National Medical Center Duarte, CA.

Responsible for completion, registration and submission of data; monitor study compliance and maintains a system for effective data flow associated with research protocols.

Play active role in recruitment of patients to study

Ability to function independently with no quality control audits besides one yearly audit

Maintain professional growth and development through seminars, workshops, and professional affiliations to maintain certification / licensure, and / or keep abreast of latest trends in field of expertise

Work with physician or nurse to see that protocol related tests are ordered per protocol guidelines

Collect and deliver specimens for analysis, CRF entry IBMTR; NMDP, Pharmaceutical and other CRF electronic entry

Specific diseases: Hodgkin’s Disease, NHL, CML, MDS, AML, Auto/Allo/MUD/Sib transplantation EDUCATION

5/19/2007 Associate in Arts Degree & Social and Behavioral Sciences Citrus College, Glendora, CA 1/71-8/72 St John Hospital Detroit, Michigan

Inhalation Therapy Trainee

CRTT Eligibility / Complete CRTT Exam in March, 1973

Complete CPFT Exam in 1975

SPECIALIZED COURSES & TRAINING

1/99 to 10/07 City of Hope National Medical Center Duarte, CA 1999

10/20 to 11/3/1999 Comprehensive Chemotherapy: A Pragmatic Approach

April 28-29, 1999 SWOG Clinical Trials Training Course 2000

SOCRA CME: 1-14-00; 2-4-00; 2-25-00

August 4, 2000 SOCRA Certified Clinical Research Professional Certification Examination Preparatory Course

September 14, 2000 Education Program on the Protection of Human Research Participants

November 6 -10, 2000 Clinical Research Professionals – Module 2

November 18, 2000 First Annual Lymphoma Conferences 2002

October 23-23, 2002 Adverse Events: A Review of Regulations & Challenging Exercises in Pharmacovigilance

October 30, 2002 Etiologic Agent Transport Training According to ICAO and DTO 49CFR172.700

December 16, 2002 Access 200 Introductions

October 18,2002 Appointed to Intuitional Review Board (IRB) non-voting member 2003

2003 HIPPA Compliance

February 21-22, 2003 Second Annual City of Hope Lung Cancer Symposium: New & Integrated Strategies for Prevention, Early Detection & Treatment of Lung Cancer

February 22, 2003 Adverse Event Grading (CTC); Adverse Event Expedited Reporting System (AdEERS); Evaluating Adverse Drug Reactions (ADRS) and ADR Reporting

November 15, 2003 Enhancing Integrity in Clinical Research

October 30, 2003 NUTS & BOLTS: A How To For Producing CMR Programs

September 27, 2003 Update On Cystic Fibrosis: Care & Treatment 2004-2008

January 23, 2004 Access 2000 Intermediate

March 2004 Certifies Clinical Research Professional exam with SOCRA

October 29-31, 2004 National Marrow Donor 2004 Council Meeting

February 18, 2005 Colorectal Cancer 2004: Current Treatments & Future Directions

November 8-11, 2006 Annual Rachmiel Levine Diabetes & Obesity Symposium: Advances in Diabetes Research from Cell Biology to Cell Therapy

November 15-18, 2006 annual HRPP Conference A Commitment to Ethical Research: Advancing the Mission of Human Research Protection Programs

April 19, 2007 Good Clinical Practices

April 30, 2007 Recertification for Certified Clinical Research Professional (SOCRA)

Attend weekly Phase I meeting to discuss participant accrual and progress of the trials, including lecture from sponsors with CEU through out the year to update finding from Phase I trials and any updates to Good Clinical Practice, FDA regulations and/or Standard Operating Procedures

2009-2015

Weekly grand rounds (research), CPR, weekly phase 1 meeting with entire phase 1 team

Cancer Research CEU which includes lung cancer, Phase 1 studies, PI initiated studies, Regulatory, CRA requirements fulfilled

Currently completing Bachelor Degree

* References provided upon request



Contact this candidate