Clinical Research Training

Angela M. Mandell, RN, BSN, CCRA

(Formerly Angela Rodenbeck) dba Mandell Clinical Research LLC

Residing in the Dallas/Fort Worth Area Phone: 512-***-****

Senior Clinical Research Associate Email: *********@*******.***

Professional Experience

24 years of overall clinical experience including:

o9 years as a Clinical Research Associate (I,II,Sr)

o12 years as Clinical Research Nurse Coordinator

Expertise in Phases I-IV clinical and device trials

Experience with several electronic data capture and remote data entry systems including diary usage

o(Inform, medidata, oracle clinical, Eclinical, FUSE, Open Clinica/CTMS (US oncology)

Experience with Response Evaluation Criteria in Solid Tumors (RECIST)

24 years experience as a nurse in various roles within the medical and pharmaceutical industry

Therapeutic Experience

CNS – Neurology – Insomnia; Pain – Dysmenorrhea (both oral medication and device trials), Dental, Post Herpetic Neuralgia Pain (device trial)

General Medicine

oAllergy – Ragweed, Cedar, Ragweed Vaccine, Pediatric Asthma – Adult; COPD; Endocrinology – Obesity; Dialysis; Diabetes Gastroenterology – Gastroesophageal Reflux Disease, Esophageal Erosion; Men’s Health – Premature Ejaculation; Urology – Benign Prostatic Hypertrophy, Overactive Bladder

Dialysis – End Stage Renal Disease

Women’s Health – Contraception, Gynecological – Female Sexual Dysfunction

Infectious Disease – Hepatitis

Oncology

oBreast, Metastatic Breast, Breast with Brain Metastasis, NSCLC, Colon, NET-Neuro endrocrine tumor, Gastric, Pancreatic, Ovarian, Non-Hodgkins Lymphoma, CML/CLL/SLL, Mantle Cell Leukemia, Multiple Myeloma, Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS), Supportive Care (Chemo-induced anemia, neutropenia), Malignant Melanoma, Pediatric Brain Cancer, Lung Cancer with Brain Metastases

INC Research

MBO Partners (US Oncology (hybrid w2-Contractors facilitator)

Independent Contractor Sr. Clinical Research Associate (CCRA)

July 2016-Present (1 year renewable contract) (part-time–10 hrs per wk, Previously 24 hrs per wk)

Responsible for monitoring/managing sites for several clinical trials; assures adherence to Good Clinical Practice, investigator integrity and compliance with all study procedures. Remote monitoring is primary and onsite monitoring is directed as needed with SIV/COVs being conducted onsite.

Primary responsibility is for site management and performance, including documentation. Site management activities include all in-house, remote monitoring (using CTMS, Iknowmed (medical record system) and several EDC systems), minimal on-site monitoring for all visit types (PSSV, SIV, IMV, COV), co-monitoring, assistance with and creation of study specific source/monitoring documents, clinical monitoring plan development, protocol review and aid in the site review/selection process. Responsible for all Regulatory essential document collection and review for all studies assigned at US Oncology Corporate, as well as maintenance of regulatory site/Central files, source document creation, monitoring tools, EDC consulting/design. Responsible for all monitoring/review of the US Oncology IP Center which houses/maintains/dispenses all IP for all trials. Responsible for all sites for current CRO trials including site monitoring, training (retraining if necessary) and review of compliance/adherence to site an USO SOPs.

oTherapeutic focus: Oncology (see above for therapeutic areas)

Clinical Research Management, Inc.

Independent Contractor – Sr. Clinical Research Associate (CCRA)

January 2017-Present (6 month renewable contract) (part-time – 10-12 hrs per week)

Responsible for monitoring/managing many sites for several clinical trials; assures adherence to Good Clinical Practice, investigator integrity and compliance with all study procedures.

Primary responsibility is for site management and performance, including documentation. Site management activities include all in-house and on-site monitoring for all visit types (PSSV, SIV, IMV, COV), co-monitoring/training as needed, assistance with study specific source/monitoring tools and aid in the site review/selection process. Responsible for all Regulatory essential document collection and review as well as maintenance of Regulatory Site/Central files, source document creation, monitoring tools, Protocol review, EDC consulting/design

oTherapeutic focus: Womens Health (High grade intraepithelial lesions-cervical (HSIL)

Randstad Healthcare

Independent Contractor – Sr. Clinical Research Associate (CCRA)

April 2015-July 2016 (6 month renewable contract - w2) (assigned to USO/McKesson)

Same contract as above with MBO-Mckesson switched carriers

Responsible for monitoring/managing sites for several clinical trials; assures adherence to Good Clinical Practice, investigator integrity and compliance with all study procedures. Remote monitoring is primary and onsite monitoring is directed as needed with SIV/COVs being conducted onsite.

Primary responsibility is for site management and performance, including documentation. Site management activities include all in-house, remote monitoring (using CTMS, Iknowmed (medical record system) and several EDC systems), minimal on-site monitoring for all visit types (PSSV, SIV, IMV, COV), co-monitoring, assistance with and creation of study specific source/monitoring documents, clinical monitoring plan development, protocol review and aid in the site review/selection process. Responsible for all Regulatory essential document collection and review as well as maintenance of regulatory site/Central files, source document creation, monitoring tools, Protocol review, EDC consulting/design

oTherapeutic focus: Oncology (many therapeutic areas)

TG Therapeutics

Independent Contractor Sr. Clinical Research Associate (CCRA)

October 2013-April 2015 (1 year renewable contract)

Responsible for monitoring/managing many sites for several clinical trials; assures adherence to Good Clinical Practice, investigator integrity and compliance with all study procedures.

Primary responsibility is for site management and performance, including documentation. Site management activities include all in-house and on-site monitoring for all visit types (PSSV, SIV, IMV, COV), co-monitoring/training as needed, assistance with study specific source/monitoring documents and aid in the site review/selection process. Responsible for all Regulatory essential document collection and review as well as maintenance of Regulatory Site/Central files, source document creation, monitoring tools, Protocol review, EDC consulting/design

oTherapeutic focus: Oncology: NHL/Leukemia (CLL/SLL)

CRA Resources

On assignment at Keryx Biopharmaceuticals

Independent Contractor Sr. Clinical Research Associate (CCRA)

July 2012-September 2014 (6 month contract-renewable)

Responsible for monitoring/managing many sites for several clinical trials; assures adherence to Good Clinical Practice, investigator integrity and compliance with all study procedures.

Primary responsibility is for site management and performance, including documentation. Site management activities include all in-house and on-site monitoring for all visit types (PSSV, SIV, IMV, COV), co-monitoring/training as needed, assistance with study specific source/monitoring documents and aid in the site review/selection process. Responsible for all Regulatory essential document collection and review as well as maintenance of Regulatory Site/Central files, source document creation, monitoring tools, Protocol review, EDC consulting/design

oTherapeutic focus: End Stage Renal Disease/Diabetes - Dialysis

RPS, Inc

Sr Clinical Research Associate (CCRA)

January 2012 – March 2012

Responsible for monitoring all types of clinical trials; assures adherence to Good Clinical Practice, investigator integrity and compliance with all study procedures.

Primary responsibility is for site management and performance, including documentation. Site management activities include all in-house and on-site monitoring for all visit types (PSSV, SIV, IMV, COV), co-monitoring, report review, CRA training & sign-off, assistance with study specific source/monitoring documents and aid in the site review/selection process. Responsible for all Regulatory essential document collection and review as well as maintenance of Regulatory Site/Central files.

oTherapeutic focus: Oncology

INC Research

Clinical Research Associate (CCRA)

April 2008 – April 2011

Responsible for monitoring all types of clinical trials; assures adherence to Good Clinical Practice, investigator integrity and compliance with all study procedures. Responsible for up to 4 protocols and 15 sites.

Primary responsibility is for site management and performance, New CRA accompaniment/review/training. Site management activities include all in-house and on-site monitoring for all visit types (PSSV, SIV, IMV, COV), co-monitoring, report review, CRA training & sign-off, assistance with study specific source/monitoring documents and aid in the site review/selection process. Responsible for all Regulatory/Pharmacy maintenance/visits for US Oncology Central Regulatory/Pharmacy offices for a large Non-Small Cell Lung Cancer Trial.

oTherapeutic focus: Oncology/Infectious Disease/Women’s Health

Texas Oncology (formerly Southwest Regional Cancer Center) - Full time and Part time

Clinical Research Nurse Coordinator

2000 – March 2006 and September 2006 - April 2008

Coordinated up to 11 actively enrolling and 5 follow-up clinical trials while complying with protocol and ICH/GCP requirements

Prepared/submitted regulatory documents supplied by Sponsors/Contract Research Organizations (CROs), to Institutional Review Boards (IRB) as required by the Food and Drug Administration (FDA)

Identified, screened and evaluated study subjects for clinical trials

Assisted Principal Investigator (PI) with all clinical procedures required by the protocol for screening, enrollment and randomization, interim and end of study visits

Maintained case report form (CRF/eCRFs) as well as source document charts for each subject

Dispensed, administered (via oral, injection and infusion) and maintained accountability for all Investigational Product (IP)

Interfaced with Radiology departments to complete required tests (CT/PET/MUGA scans) per protocol requirements

Performed electrocardiograms (ECGs), administered quality of life (QOL) questionnaires (both electronic and paper) and obtained and processed blood samples for safety, pharmacodynamic and pharmacokinetic testing

Participated in all types of monitoring visits including, site selection, initiation, interim monitoring and close-out visits

Attended Investigator Meetings and Recruitment meetings as required by the Sponsor

Conducted protocol and procedure training for pharmacy, nursing, laboratory and radiology technicians and other study personnel on the specific protocol required procedures

Lovelace Scientific Resources

Clinical Research Nurse Coordinator

March 2006 – September 2006

Provided daily Coordinator oversight as well as performing in a Coordinator role

Prepared and submitted regulatory documents supplied by Sponsors/CROs, to the IRB as required by the FDA

Identified, screened and evaluated study subjects for clinical trials

Assisted with advertising campaigns for mass recruitment

Assisted PI with all clinical procedures required by the protocol for screening, enrollment/randomization, interim and end of study visits which included all tests required such as ECGs, Pulmonary Function Tests, Allergy screening skin tests, neurological skin tests and blood drawing/processing for safety, pharmacodynamic and pharmacokinetic testing

Dispensed, administered and maintained accountability for all IP and devices, including schedule 2 drugs

Maintained CRF/eCRFs as well as source document shadow charts for each subject

Assisted CRA with pre-study site selection, initiation, interim and close-out visits and query resolution

Conducted protocol procedure training for new coordinators, nursing staff, laboratory staff, shot clinic technicians and any other study personnel the protocol required

Contract Clinical Research Nurse Coordinator (for the following):

Professional Quality Research

2001-2003 (In tandem with Southwest Regional Cancer Center)

CEDRA Clinical Research

1998 – 1999

Allergy and Asthma Associates of Austin

1997

Austin Diagnostic Center – Allergy Clinic

1996

Coordinated up to 4 actively enrolling clinical trials while complying with protocol and ICH/GCP requirements

Identified (through advertising, patient charts and database), screened and evaluated study subjects for clinical trials

Assisted the PI/Sub-I with all clinical procedures required by the protocol for screening, enrollment/randomization, interim and end of study visits

Performed ECGs, bladder scans, urinary retention measurements, allergy skin testing, skin temperature testing, patient teaching, administered QOL questionnaires and obtained/processed blood samples for safety, pharmacodynamic and pharmacokinetic testing

Dispensed, administered and maintained accountability for all IP and devices

Managed and maintained all CRFs, source documents/patient charts and study logs per protocol

Participated in Interim Monitoring Visits with the CRA for monitoring of protocol compliance, data and regulatory binders as well as query resolution

Attended Investigator Meetings and Recruitment meetings as required by the Sponsor

Conducted protocol/procedure training for nursing staff and other study personnel on the specific protocols they were assigned to

Premier Research - (formerly Scirex Corporation)

Clinical Research Nurse Coordinator

1996

Coordinated actively enrolling clinical Pain trials while complying with protocol and ICH/GCP requirements

Identified (through advertising), screened and evaluated study subjects for clinical trials

Assisted the PI with all clinical procedures required by the protocol for screening, enrollment/randomization, interim and end of study visits

Obtained/processed blood samples for pharmacodynamic and pharmacokinetic testing

Performed pain evaluations and histories and administered Pain Scale assessments

Dispensed, administered and maintained accountability for all IP

Managed and maintained all CRFs, source documents/patient charts and study logs per protocol

Barton Creek Home Care

Staff Home Health Nurse (Pediatrics)

1994-1995

Performed all aspects of nursing care for pediatric patients on ventilators residing at home

Children’s Hospital of Oklahoma

Staff Pediatric ICU Nurse

1993 – 1994

Performed all functions required by the department as a Staff ICU Nurse in the Pediatric ICU

Ongoing training for parents to care for their critically ill children

University of Texas

Arlington, TX

Bachelor of Science in Nursing

1993

INC Research

Core II Advanced CRA Clinical Training – October 2009

Introduction to Clinical Monitoring – April 2008

CRA GCP – Foundations Training – April 2008

Core Clinical Training – April 2008

CCRA (yearly maintenance since 2011)

Oracle RDC (2017)

Citrix (2016)

CTMS (2016)

Merge EDC training 2015

E-Pro diary training 2015

Iknowmed medical record training 2015 (US Oncology)

ICH/GCP training 2015

ICH/GCP training 2012

IVRS training module 2012 Retraining (Sanofi Assigned Course)

Glucometers training 2012 (Sanofi Assigned Course)

Audits and Inspections 2012 Retraining (Sanofi Assigned Course)

Protection of Human Subjects in Clinical Trials 2012 Retraining (Sanofi Assigned Course)

ICH/GCP Obligations of Sponsors, Monitors and Investigators 2012 Retraining (Sanofi Assigned Course)

Blood Borne Pathogen Training 2012 Retraining (Sanofi Assigned Course)

Hospitality Rules for Healthcare Professionals 2012 (Sanofi Assigned Course)

Global Anti-bribery Course 2012 (Sanofi Assigned Course)

ACRP Certified Clinical Research Associate (CCRA) 2010

Chemotherapy Certification (Oncology Nursing Society) 2007

Hazardous Materials Air Shipper Certification (IATA) 2000-2007

Quality of Life Questionnaire Administration Training 2000

Recist Guidelines Training 2000, 2010

Pain Assessment Scale Administration Training 1996

Memberships/Affiliations

Member of ACRP/CCRA (National and Local chapters)

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