Clinical Research Associate
Resume:
Francis_Beatriz_**-Dec-**** Page * of **
Beatriz (Judy) Francis
Senior Clinical Research Associate
ICON Clinical Research
Atlanta, GA USA
Education
University of Houston-University Park, Houston, Texas Bachelor of General Studies
Major: Psychology
Summary
• Over 20 years of experience working in the clinical research industry with over 18 years as a Clinical Research Associate.
• Over 3 years of experience working for ICON PLC/Pfizer Oncology GSSO
• Over 2 years of experience working for Synteract until the pandemic strikes.
• Over 4 years of experience working for Catawba Clinical Research.
• Clinical Research Therapeutic Areas include:
Indication Phase I, II, III, or IV
Highest Role Within
Indication
Cardiovascular
Hypertension II, IV Sr. CRA
Cardiovascular Outcome Study II, III, IV Sr. CRA
Dermatological
Psoriasis I, II, III, IV Sr. CRA
Rosacea I, II, III, IV Sr. CRA
Acne Vulgaris I, II, III, IV Sr. CRA
Device
Disposable Injectable Diabetic Insulin Device II, III, IV Sr. CRA Gastrointestinal
GERD I, II, III, IV Sr. CRA
Irritable Bowel Syndrome II, III Sr. CRA
Peptic Ulcer I, II, III Sr. CRA
Infectious Disease
HIV-Infected Patients III, IV Sr. CRA
Hepatic Dysfunction I, II, III Sr. CRA
Mental Disorders
Francis_Beatriz_15-Dec-2024 Page 2 of 11
Major Depressive Disorder I, II, III, IV CRA II
Bipolar II, III, IV CRA II
Nocturnal Enuresis Alzheimer Dementia II, III, IV CRA II Dementia II, III, IV CRA II
Children with ADHD II, III Sr. CRA
Metabolic Disorders
Diabetes Mellitus Types I and II Morbid
Obesity (SAGB)
I, II, III Sr. CRA
Diabetes Mellitus Types I and II Morbid
Obesity (SAGB)
I, II, III, IV Sr. CRA
Musculoskeletal & Connective Tissue Disorder
Osteoarthritis II, III, IV Sr. CRA
Neurology/Urology
Diabetic Neuropathy I, II, III CRA II
Diabetes Mellitus Types I and II II, IV Sr. CRA
Oncology
Kidney Cancer II, III, IV Sr. CRA
Liver Cancer II, III, IV Sr. CRA
Lymphoma I, II, III, IV Sr. CRA
Multiple Myeloma II, III Sr. CRA
Ovarian Cancer I, II, III, IV Sr. CRA
Pelvic Cancer II, III Sr. CRA
Respiratory
Rhinitis II, III, IV CRA II
Adult mild to moderate asthma II, III, IV CRA II
• Professional Licenses/Affiliations/Memberships:
o Certified Clinical Research Associate
o Certified Biofeedback Medical Technician January 1994 o Certified GCP/ICH Trainer September 1995 - yearly training o Certified EDC Trainer (InForm 4.5, Oracle, e-Trial, Phosco, and Rave) January 2000 - yearly training.
• Experience in Electronic Data Capture trials: Medidata RAVE, INFORM, Merge EDC, OmniTrial EDC, Medrio EDC, eTrial, Phosco.
• Languages (fluency, verbal and written): English (verbal and written), Spanish (verbal and written) Francis_Beatriz_15-Dec-2024 Page 3 of 11
Professional Experience
ICON Clinical Research
Job Title:
Senior Clinical Research
Associate
November 2020 to
Present
Job Description:
Identify, select, initiate, and close out appropriate investigational sites for clinical studies. Monitor those sites to ensure that studies are carried out according to the study protocol, ICON SOPs/WPs, applicable regulations, and the principles of ICH- GCP Depending upon experience, become involved, when required, in other areas of study management and staff training and contribute to the review of ICON systems and procedures as appropriate. Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues.
Study Assignments
Project Description: A Phase 3, Multinational, Randomized, Open-Label, Three Parallel-Arm Study of PF-06801591, an anti-PD-1 antibody, in Combination with Bacillus Calmette Guerin (BCG Induction with or Without BCG Maintenance) Versus BCG
(Induction and Maintenance) in Participants with High-Risk, BCG Naïve Non-Muscle Invasive Bladder Cancer. Project Description: A Phase I Dose Escalation and Expanded Cohort Study of PF-06821497 (Mevrometostat) in the Treatment of Adult Patients with Relapsed/Refractory Small Cell Lung Cancer (SCLC), Castration Resistant Prostate Cancer (CRPC) And Follicular Lymphoma (FL).
Project Description: An Interventional, Open-Label, Randomized, Multicenter Phase 3 Study of PF-07220060 Plus Fulvestrant Compared to Investigator’s Choice of Therapy in Participants Over 18 years of Age with Hormone Receptor-Positive, Her2- Negative Advanced/Metastatic Breast Cancer Whose Disease Progressed After Prior CDK 4/6 Inhibitor-Based Therapy. Project Description: A Phase 2a, Randomized, Double-Blind, Sponsor-Open, Placebo-Controlled, Parallel Group Study to Assess the Safety, Tolerability, and Pharmacodynamics of PF-06882961 Titration in Adults with Type 2 Diabetes Mellitus Treated with Metformin and in Non-Diabetic Adults with Obesity. Responsibilities:
- Conducts site initiation with study personnel to ensure an accurate understanding of the protocol, study procedures, case report form, adverse event reporting, and use and storage of clinical trial materials.
- Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures.
- Conducts interim monitoring visits according to the sponsor SOPs and individual study SPAs.
- Reviews the quality and integrity of the clinical data according to sponsor SOPs and SPA guidelines through (1) on-site source verification and (2) in-house review of electronic CRF data.
- Submits monitoring trip reports, follow-up letters, and phone reports according to sponsor SOPs and builds and maintains long-term professional relationships with clinical investigators.
- Reviewed eCRFs (Electronic Clinical Record Forms) off-site and during on-site visits through careful and consistent evaluation against protocols and source documents – per FDA and ICH guidelines. - Study Sites handled: USA (10 Sites) Francis_Beatriz_15-Dec-2024 Page 4 of 11
Synteract
Job Title:
Senior Clinical
Research Associate
June 2019 to
November 2020
Job Description: Identify, select, initiate, and close out appropriate investigational sites for clinical studies. Monitor those sites to ensure that studies are carried out according to the study protocol, Synteract SOPs/WPs, applicable regulations, and the principles of ICH- GCP Depending upon experience, become involved, when required, in other areas of study management and staff training and contribute to the review of the company systems and procedures as appropriate. Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues. Study Assignments
Project Description: General monitoring of Phase III - A Study for Subjects with Irritable Bowel Syndrome with Diarrhea (IBS-D) or Constipation (IBS-C)
Responsibilities:
- Conducts site initiation with study personnel to ensure an accurate understanding of the protocol, study procedures, case report form, adverse event reporting, and use and storage of clinical trial materials.
- Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures.
- Conducts interim monitoring visits according to the sponsor SOPs and individual study SPAs.
- Reviews the quality and integrity of the clinical data according to sponsor SOPs and SPA guidelines through (1) on-site source verification and (2) in-house review of electronic CRF data.
- Submits monitoring trip reports, follow-up letters, and phone reports according to sponsor SOPs and builds and maintains long-term professional relationships with clinical investigators.
- Reviewed eCRFs (Electronic Clinical Record Forms) off-site and during on-site visits through careful and consistent evaluation against protocols and source documents – per FDA and ICH guidelines.
- Study Sites handled: USA (7 Sites)
Array BioPharma
Job Title:
Senior Clinical
Research Associate
March 2018 – June
2019
Job Description:
Identify, select, initiate, and close out appropriate investigational sites for clinical studies. Monitor those sites to ensure that studies are carried out according to the study protocol, Array Biopharma SOPs/WPs, applicable regulations, and the principles of ICH- GCP Depending upon experience, become involved, when required, in other areas of study management and staff training and contribute to the review of the company systems and procedures as appropriate. Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues. Study Assignments
Project Description: Ovarian Cancer, Phase III multicenter study evaluating patients with follicular lymphoma (April 2013 – January 2018) A Phase Ib/II, Open-label Study in Adult Patients with NRAS Mutant Melanoma (May 2013 – July 2015) Francis_Beatriz_15-Dec-2024 Page 5 of 11
Responsibilities:
- Conducts site initiation with study personnel to ensure an accurate understanding of the protocol, study procedures, case report form, adverse event reporting, and use and storage of clinical trial materials.
- Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures.
- Conducts interim monitoring visits according to the sponsor SOPs and individual study SPAs.
- Reviews the quality and integrity of the clinical data according to sponsor SOPs and SPA guidelines through (1) on-site source verification and (2) in-house review of electronic CRF data.
- Submits monitoring trip reports, follow-up letters, and phone reports according to sponsor SOPs and builds and maintains long-term professional relationships with clinical investigators.
- Reviewed eCRFs (Electronic Clinical Record Forms) off-site and during on-site visits through careful and consistent evaluation against protocols and source documents – per FDA and ICH guidelines.
- Study Sites handled: USA (8 Sites)
Catawba Research, LLC.
Job Title:
Senior Clinical
Research Associate
September 2015 –
March 2018
Job Description:
Identify, select, initiate, and close out appropriate investigational sites for clinical studies. Monitor those sites to ensure that studies are carried out according to the study protocol, Catawba SOPs/WPs, applicable regulations, and the principles of ICH- GCP Depending upon experience, become involved, when required, in other areas of study management and staff training and contribute to the review of the company systems and procedures as appropriate. Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues. Study Assignments
Project Description: The Treatment of Tinea Pedis, Active Infestation with Head Lice and Their Ova, The Treatment of Scalp Psoriasis, Treatment of Moderate Facial Rosacea.
Project Description: Active Treatments Compared to Placebo (Vehicle) in the Treatment of Acne Vulgaris Responsibilities:
- Conducts site initiation with study personnel to ensure an accurate understanding of the protocol, study procedures, case report form, adverse event reporting, and use and storage of clinical trial materials.
- Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures.
- Conducts interim monitoring visits according to the sponsor SOPs and individual study SPAs.
- Reviews the quality and integrity of the clinical data according to sponsor SOPs and SPA guidelines through (1) on-site source verification and (2) in-house review of electronic CRF data.
- Submits monitoring trip reports, follow-up letters, and phone reports according to sponsor SOPs and builds and maintains long-term professional relationships with clinical investigators.
- Reviewed eCRFs (Electronic Clinical Record Forms) off-site and during on-site visits through careful and consistent evaluation against protocols and source documents – per FDA and ICH guidelines.
- Study Sites handled: USA (14 Sites)
Francis_Beatriz_15-Dec-2024 Page 6 of 11
Quintiles/ Aerotek
Job Title:
Senior Clinical
Research Associate
November 2014 –
September 2015
Job Description:
Identify, select, initiate, and close out appropriate investigational sites for clinical studies. Monitor those sites to ensure that studies are carried out according to the study protocol, Aerotek SOPs/WPs, applicable regulations, and the principles of ICH- GCP Depending upon experience, become involved, when required, in other areas of study management and staff training and contribute to the review of the company systems and procedures as appropriate. Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues. Study Assignments
Project Description: Amgen Melanoma Treatment of Previously Untreated, Unresected, Stage IIIB to IVM1c Melanoma Responsibilities:
- Conducts site initiation with study personnel to ensure an accurate understanding of the protocol, study procedures, case report form, adverse event reporting, and use and storage of clinical trial materials.
- Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures.
- Conducts interim monitoring visits according to the sponsor SOPs and individual study SPAs.
- Reviews the quality and integrity of the clinical data according to sponsor SOPs and SPA guidelines through (1) on-site source verification and (2) in-house review of electronic CRF data.
- Submits monitoring trip reports, follow-up letters, and phone reports according to sponsor SOPs and builds and maintains long-term professional relationships with clinical investigators.
- Reviewed eCRFs (Electronic Clinical Record Forms) off-site and during on-site visits through careful and consistent evaluation against protocols and source documents – per FDA and ICH guidelines.
- Study Sites handled: USA (7 Sites)
Salix Pharmaceuticals
Job Title:
Senior Clinical
Research Associate
February 2011 –
November 2014
Job Description:
Identify, select, initiate, and close out appropriate investigational sites for clinical studies. Monitor those sites to ensure that studies are carried out according to the study protocol, Salix SOPs/WPs, applicable regulations, and the principles of ICH- GCP Depending upon experience become involved, when required, in other areas of study management and staff training and contribute to the review of the company systems and procedures as appropriate. Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues. Study Assignments
Project Description: Irritable Bowel Syndrome with Diarrhea (IBS-D) General monitoring of Phase III - A Study for Subjects with Irritable Bowel Syndrome with Diarrhea (IBS-D) Francis_Beatriz_15-Dec-2024 Page 7 of 11
Responsibilities:
- Conducts site initiation with study personnel to ensure an accurate understanding of the protocol, study procedures, case report form, adverse event reporting, and use and storage of clinical trial materials.
- Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures.
- Conducts interim monitoring visits according to the sponsor SOPs and individual study SPAs.
- Reviews the quality and integrity of the clinical data according to sponsor SOPs and SPA guidelines through (1) on-site source verification and (2) in-house review of electronic CRF data.
- Submits monitoring trip reports, follow-up letters, and phone reports according to sponsor SOPs and builds and maintains long-term professional relationships with clinical investigators.
- Reviewed eCRFs (Electronic Clinical Record Forms) off-site and during on-site visits through careful and consistent evaluation against protocols and source documents – per FDA and ICH guidelines.
- Study Sites handled: USA (6 Sites)
Cytochrome, Inc
Job Title:
Senior Clinical
Research Associate
July 2009 – February
2011
Job Description:
Identify, select, initiate, and close out appropriate investigational sites for clinical studies. Monitor those sites to ensure that studies are carried out according to the study protocol, Cytochrome SOPs/WPs, applicable regulations, and the principles of ICH- GCP Depending upon experience, become involved, when required, in other areas of study management and staff training and contribute to the review of the company systems and procedures as appropriate. Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues. Study Assignments
Project Description: Chronic Kidney disease. A Randomized, Double-Blind, Placebo-Controlled, Repeat Dose, Safety, Efficacy, and Pharmacokinetic/Pharmacodynamic Study of CTAP101 Capsules in Subjects with Chronic Kidney disease, Vitamin D Insufficiency, and Secondary Hyperparathyroidism
Responsibilities:
- Conducts site initiation with study personnel to ensure an accurate understanding of the protocol, study procedures, case report form, adverse event reporting, and use and storage of clinical trial materials.
- Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures.
- Conducts interim monitoring visits according to the sponsor SOPs and individual study SPAs.
- Reviews the quality and integrity of the clinical data according to sponsor SOPs and SPA guidelines through (1) on-site source verification and (2) in-house review of electronic CRF data.
- Submits monitoring trip reports, follow-up letters, and phone reports according to sponsor SOPs and builds and maintains long-term professional relationships with clinical investigators.
- Reviewed eCRFs (Electronic Clinical Record Forms) off-site and during on-site visits through careful and consistent evaluation against protocols and source documents – per FDA and ICH guidelines.
- Study Sites handled: USA (7 Sites)
Francis_Beatriz_15-Dec-2024 Page 8 of 11
Novella Clinical Resourcing
Job Title:
Senior Clinical
Research Associate
August 2003 – July
2009
Job Description:
Identify, select, initiate, and close out appropriate investigational sites for clinical studies. Monitor those sites to ensure that studies are carried out according to the study protocol, Novella SOPs/WPs, applicable regulations, and the principles of ICH- GCP Depending upon experience, become involved, when required, in other areas of study management and staff training and contribute to the review of the company systems and procedures as appropriate. Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues. Study Assignments
Project Description: Phase III Active - Controlled Study in patients with CLOSTRIDIUM DIFFICILE ASSOCIATED; Phase III, randomized, double-blind, dose-controlled study to assess the efficacy and safety of AQUAVAN injection for minimal to moderate sedation in patients undergoing flexible Bronchoscopy; areas (hormone replacement therapy, osteoporosis prevention, cholesterol-lowering, perimenopause, dysmenorrheal, acne treatment with OCPs, family planning, fibroids, polycystic ovarian syndrome, vaginitis, obesity, hypoactive sexual desire disorder, endometriosis, menopause). A 12-Week, Double-blind, Patients with Type 2 Diabetes Mellitus. Responsibilities:
- Conducts site initiation with study personnel to ensure an accurate understanding of the protocol, study procedures, case report form, adverse event reporting, and use and storage of clinical trial materials.
- Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures.
- Conducts interim monitoring visits according to the sponsor SOPs and individual study SPAs.
- Reviews the quality and integrity of the clinical data according to sponsor SOPs and SPA guidelines through (1) on-site source verification and (2) in-house review of electronic CRF data.
- Submits monitoring trip reports, follow-up letters, and phone reports according to sponsor SOPs and builds and maintains long-term professional relationships with clinical investigators.
- Reviewed eCRFs (Electronic Clinical Record Forms) off-site and during on-site visits through careful and consistent evaluation against protocols and source documents – per FDA and ICH guidelines.
- Study Sites handled: USA (6 Sites)
INC
Job Title:
Senior Clinical
Research Associate
July 2000 – August
2003
Job Description:
Identify, select, initiate, and close out appropriate investigational sites for clinical studies. Monitor those sites to ensure that studies are carried out according to the study protocol, INC SOPs/WPs, applicable regulations, and the principles of ICH- GCP Depending upon experience, become involved, when required, in other areas of study management and staff training and contribute to the review of the company systems and procedures as appropriate. Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues. Study Assignments
Project Description: Irritable Bowel Syndrome with Constipation (IBS-C). A Double-Blind, in Patients with Irritable Bowel Syndrome with Constipation (IBS-C), Monitored several sites that participated in a clinical trial for a prospective, multinational, multicenter, double-blind, Placebo-controlled Dose to Assess the Safety and Efficacy of Plecanatide in Patients with IBS-C; Monitored several sites that participated in a clinical trial for a prospective, multinational, multicenter, double-blind, randomized, active-controlled trial.
Francis_Beatriz_15-Dec-2024 Page 9 of 11
Responsibilities:
- Conducts site initiation with study personnel to ensure an accurate understanding of the protocol, study procedures, case report form, adverse event reporting, and use and storage of clinical trial materials.
- Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures.
- Conducts interim monitoring visits according to the sponsor SOPs and individual study SPAs.
- Reviews the quality and integrity of the clinical data according to sponsor SOPs and SPA guidelines through (1) on-site source verification and (2) in-house review of electronic CRF data.
- Submits monitoring trip reports, follow-up letters, and phone reports according to sponsor SOPs and builds and maintains long-term professional relationships with clinical investigators.
- Reviewed eCRFs (Electronic Clinical Record Forms) off-site and during on-site visits through careful and consistent evaluation against protocols and source documents – per FDA and ICH guidelines.
- Study Sites handled: USA (10 Sites)
RPS
Job Title:
Senior Clinical
Research Associate
January 1998 – July
2000
Job Description:
Identify, select, initiate, and close out appropriate investigational sites for clinical studies. Monitor those sites to ensure that studies are carried out according to the study protocol, RPS SOPs/WPs, applicable regulations, and the principles of ICH- GCP Depending upon experience, become involved, when required, in other areas of study management and staff training and contribute to the review of the company systems and procedures as appropriate. Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues. Study Assignments
Project Description: HIV-Infected. A Randomized, Monitored multiple sites that participated in a clinical trial for the long-term safety and efficacy study as initial treatment in HIV-Infected patients Responsibilities:
- Conducts site initiation with study personnel to ensure an accurate understanding of the protocol, study procedures, case report form, adverse event reporting, and use and storage of clinical trial materials.
- Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures.
- Conducts interim monitoring visits according to the sponsor SOPs and individual study SPAs.
- Reviews the quality and integrity of the clinical data according to sponsor SOPs and SPA guidelines through (1) on-site source verification and (2) in-house review of electronic CRF data.
- Submits monitoring trip reports, follow-up letters, and phone reports according to sponsor SOPs and builds and maintains long-term professional relationships with clinical investigators.
- Reviewed eCRFs (Electronic Clinical Record Forms) off-site and during on-site visits through careful and consistent evaluation against protocols and source documents – per FDA and ICH guidelines.
- Study Sites handled: USA (5 Sites)
Francis_Beatriz_15-Dec-2024 Page 10 of 11
Ely Lilly Research Laboratories
Job Title:
Senior Clinical
Research Associate
September 1995 -
January 1998
Job Description:
Identify, select, initiate, and close out appropriate investigational sites for clinical studies. Monitor those sites to ensure that studies are carried out according to the study protocol, Lili Research SOPs/WPs, applicable regulations, and the principles of ICH- GCP Depending upon experience, become involved, when required, in other areas of study management and staff training and contribute to the review of the company systems and procedures as appropriate. Provide a benchmark of monitoring competence to inexperienced/less experienced colleagues. Study Assignments
Project Description: Division of Mental Health Psychiatric – CNS Psychosis associated with Dementia Monitored several sites participating in the following Therapeutic Areas:
• Lilly Research Laboratories, Olanzapine versus Placebo in the Treatment of Patient with Psychosis associated with Dementia
• Protocol Olanzapine versus Placebo in the Treatment of Psychosis and Behavioral Disturbance Associated with Alzheimer's Disease.
• (Lilly Research Laboratories), Treatment of Bipolar I Mania
• (Lilly Research Laboratories), Combination Therapy in the Treatment of Bipolar I Depression
• (Lilly Research Laboratories), Treatment of Treatment-Resistant Depression without Psychotic Features Responsibilities:
- Conducts site initiation with study personnel to ensure an accurate understanding of the protocol, study procedures, case report form, adverse event reporting, and use and storage of clinical trial materials.
- Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures.
- Conducts interim monitoring visits according to the sponsor SOPs and individual study SPAs.
- Reviews the quality and integrity of the clinical data according to sponsor SOPs and SPA guidelines through (1) on-site source verification and (2) in-house review of electronic CRF data.
- Submits monitoring trip reports, follow-up letters, and phone reports according to sponsor SOPs and builds and maintains long-term professional relationships with clinical investigators.
- Reviewed eCRFs (Electronic Clinical Record Forms) off-site and during on-site visits through careful and consistent evaluation against protocols and source documents – per FDA and ICH guidelines.
- Study Sites handled: USA (12 Sites)
Contact this candidate