Breana' Quick

Contract Clinical Research Associate on phases IA,IA/B, and B open-label multi-center trial evaluating pharmacokinetics, pharmacodynamics safety and efficacy in Oncology for adult subjects. Performing Site Management, Study Monitoring including on-site IMVs, remote SIVs, and COVs. Performing 100% and/or reduced SDV during on-site and remote visits using EDC (InForm), SharePoint, Pfizer Trial Master File (pTMF). Reviewing both electronic and on-site source for enrolled subjects, electronic and hard copies of the Investigator Site File (ISF). Performing IP accountability and management; supporting interim analysis and/or database locks; provide query resolution to sites.

Contract Clinical Research Associate on 5 phases II-III, randomized Clinical trials in Infectious/Parasitic diseases (COVID-19), Devices (Associate Sample Collection Program, Women’s Health-External Biospecimen Acquisition Program) in adult subjects. Performed Site Management and Study Monitoring for clinical studies conducted by Global Clinical Development (GCD). Performed on-site (IMV and COV), remote (SIV, IMV) and/or in-house monitoring activities. Performed start-up activities, Initiation, Interim monitoring visits. Performed 100% or reduced SDV during on-site and remote visits using EDC (ClindexLIVE), SharePoint and Veeva Vault for reporting. Reviewed on-site Investigator files and ensured subject safety by overseeing timely and accurate AE/SAE reporting and follow-up. Maintained regular site staff contacts, trainings and query resolution support.

In-House Clinical Research Associate on 1 phase II and randomized Cardiovascular study (Atrial fibrillation) in adults, for approximately 30-50 clinical sites with minimal to no guidance. Performed Site Management, Remote IMVs, reduced SDV, and in-house monitoring activities. Performed reduced SDV using EDC (iMedidata) eCRFs and in-house local CTMS system for reporting. Acted as primary study contact and guided site through study procedures. Independently assessed protocol and regulatory compliance, including but not limited document verification, informed consent process and human patient protection, data integrity, drug accountability and compliance, and review of investigator and regulatory files. Reviewed on-site Investigator files and ensured subject safety by overseeing timely and accurate AE/SAE reporting and follow-up. Maintained regular site staff contacts, trainings and query resolution support. Worked with sites to ensure data collection, entry and cleaning are complete, and that benchmarks/timelines for completion are maintained with minimal to no guidance. Provided training, assistance and follow-up for appropriate query resolution for appropriate resolution and source documentation.

Contract Clinical Research Associate III on 2 phase III, open-label and randomized Hematology/Oncology (Prostate cancer) Clinical trials in adult male subjects. Monitored the progress of clinical studies at investigative sites or remotely. Performed interim monitoring visits, 100% or reduced SDV during on-site and remote visits using EDC (DataLabs) and in-house local CTMS system for reporting. Maintained regular site staff contacts, trainings and query resolution support. Ensured clinical trial trials are conducted, recorded, and reported in accordance with the protocol, Standard Operating Procedures (SOPs), ICH-GCP and all applicable regulatory requirements. Conducted interim monitoring and co-monitoring visits with fellow study CRA colleagues. Reviewed on-site files and records, drug accountability, study supplies inventory, case report forms, and source documents for completeness, accuracy, consistency and compliance. Identified deficiencies/discrepancies and provided remedial training and/or initiated corrective action as required.

Clinical Research Associate III on 2 phase II-III randomized studies in Hematology/Oncology (Lung cancer-NSCLC and Melanoma) in adult subjects. Performed start-up activities, initiation and interim monitoring visits. Performed 100% or reduced SDV during on-site and remote visits using EDC (InForm) and in-house local CTMS system (Siebel) for reporting. Reviewed on-site Investigator files and ensured subject safety by overseeing timely and accurate AE/SAE reporting and follow-up. Used IVRS for IP set-up, accountability, and management. Maintained regular site staff contacts, trainings and query resolution support. Participated in local interim analysis. Trained study site personnel on the research protocol and study procedures, and electronic data capture as required. Conducted Interim Monitoring Visits according to sponsor SOPs. Submitted monitoring trip reports, follow-up letters, and phone report according to sponsor SOPs. Worked with sites to assure appropriate and timely submission IRB/IEC documents for approval.

Independent Contractor Clinical Research Associate on 1 phase III open-label and randomized Clinical trial in Endocrinology/Metabolic Disease (Obesity) in adult subjects. Performed start-up activities, initiation, interim and close-out monitoring visits. Performed 100% SDV during on-site visits using EDC and paper CRFs and in-house local CTMS system for reporting. Reviewed on-site Investigator files and ensured subject safety by overseeing timely and accurate AE/SAE reporting and follow-up. Used IVRS for IP set-up, accountability and management. Maintained regular site staff trainings and query resolution support. Participated in the study development and start-up process including reviewing protocols, designing and/or reviewing case report forms, preparing Informed Consent Forms (ICFs), developing study documents, organizing and presenting at Investigator meetings, working with management on monitoring strategy, and/or developing project-specific CRA training.

In-House Clinical Research Associate on 1 phase II and randomized Cardiovascular and Endocrine study (Lipid Disorders, Acute Coronary Syndrome) in adult subjects. Performed Site Management, remote monitoring visits (RMVs), bi-weekly calls, reduced SDV using EDC (InForm) eCRFs and in-house local CTMS system for reporting. Collected, compiled, documented and supported clinical research data via remote site monitoring. Reviewed on-site Investigator files and ensured subject safety by overseeing timely and accurate AE/SAE reporting and follow-up. Maintained regular site staff contacts, trainings and query resolution support. Evaluated and assured quality of data collected; ensured that all data and study documents are handled consistently with the demands of regulatory agencies with respect to data protection.

Senior Lead Clinical Research Associate on 5 phases II-IV double-blind, open label and randomized Clinical trials in Hematology/Oncology (Breast-Adjuvant/Metastatic, Colon, Gastrointestinal, Melanoma, Lung-NSCLC) in adult subjects. Performed start-up activities, initiation, interim and close-out monitoring visits. Perfomed 100% or reduced SDV during on-site and remote visits using EDC (InForm) and paper CRFs and in-house local CTMS system for accurate AE/SAE reporting and follow-up. Used IVRS for IP set-up, accountability and management. Maintained regular site staff contacts, trainings and query resolution support. Performed timely and accurate Clinical Trials Management System (CTMS) data entry per department training. Assisted Clinical Trial Manager (CTM) in researching and confirming audit follow-up items. Engaged in Lead CRA monitoring activities, when assigned, including creation of Clinical Monitoring Plan, Monitoring Tools. Provided input into case report forms and study-related guides, co-monitored and performed study-specific training for new CRAs staff as needed. Assisted CTM with vendor management (i.e., central laboratories), trip report review as needed and facilitated communication of study related activities to study team.

Clinical Research Associate Field Trainer on 5 phases II-IV double-blind, open label and randomized clinical trials in Hematology/Oncology (Breast-Adjuvant/Metastatic, Colon, Gastrointestinal, Melanoma, Lung-NSCLC) in adult subjects. Performed start-up activities, initiation, interim, close-out monitoring visits and SWAT monitoring. Performed 100% or reduced SDV during on-site and remote visits using EDC (InForm) and paper CRFs and in-house local CTMS system for accurate AE/SAE reporting and follow-up. Used IVRS for IP set-up, accountability and management. Maintained regular site staff contacts, trainings and query resolution support. Performed timely and accurate Clinical Trials Management System (CTMS) data entry per department training. Assisted Clinical Trial Manager (CTM) in researching and confirming audit follow-up items. Developed on-site training assessment checklists for all types of monitoring visits that are utilized to assess contractor, regional, and permanent CRAs. Developed/Revised Standard Operating Procedures (SOPs) and Working Practice Documents (WPDs) for all types of monitoring visits-PSSVs; SIV; IMV, COV; scheduling monitoring visits/submitting trip reports. Created/Implemented monthly Lunch and Learn seminars for Global Clinical Operations for entire NC office.

Lead Clinical Research Associate on 1 phase II and randomized Clinical trial in Adjuvant/Metastatic breast cancer in adult female subjects. Assisted with interviewing, selecting, training, mentoring and development of new employees (e.g., co-monitoring). Assisted study-assigned Clinical Trial Manager (CTM) with review of monitoring visit reports. Created/generated for study team members the protocol Monitoring Plan/study specific monitoring tools. Assisted with on-site audit responses.

Clinical Research Associate II on 1 phase III randomized Hematology/Oncology Clinical trial in kidney cancer for adult subjects. Performed start-up activities, Initiation, Interim and Close-Out monitoring visits. Performed 100% or reduced SDV during on-site and remote visits EDC and paper CRFs and in-house local CTMS system for reporting. Reviewed on-site Investigator files and ensured subject safety by overseeing timely and accurate AE/SAE reporting and follow-up. Used IVRS for IP set-up, accountability and management. Maintained regular site staff contacts, trainings and query resolution support. Recruited Investigators for participation in clinical trials.

Clinical Research Associate II on 1 phase III-IV and randomized, open label Clinical trial in Respiratory (Asthma)in adult subjects. Performed start-up activities, initiation, interim and close-out monitoring visits. Interacted with physicians, investigators, site staff and vendor/CRO personnel and performed study initiation, routine and study close-out monitoring visits to ensure compliance with GCPs for clinical studies and

investigation entities filed under U.S IND, IDE, or other FDA requirements. Performed 100% SDV during on-site visits using EDC and paper CRFs and in-house local CTMS system for reporting. Reviewed on-site Investigator files and ensured subject safety by overseeing timely and accurate AE/SAE reporting and follow-up. Maintained regular site staff contacts, trainings and query resolution support. Reviewed source documents and Case Report Forms (CRFs) of each patient in accordance with Federal regulations and monitoring guidelines to ensure accuracy.

Clinical Research Associate on 3 phases II-III double-blind and randomized Clinical trials in Genitourinary (Women’s Health, Contraception, Menopausal Disorder, Sexual Dysfunction) in female adult subjects. Performed start-up activities, initiation, interim and close-out monitoring visits. Performed 100% or reduced SDV during on-site and remote visits using EDC and paper CRFs and in-house local CTMS system for reporting. Reviewed on-site Investigator files and ensured subject safety by overseeing timely and accurate AE/SAE reporting and follow-up. Used IVRS for IP set-up, accountability and management. Maintained regular site staff contacts, trainings and query resolution support. Reviewed/tracked regulatory documents. Identified, documented, and resolved deficiencies relating to subject enrollment, study data and study conduct. Maintained study-specific Project Management Database.

Clinical Research Associate on phases II-III Oncology studies in adult subjects. Educated ancillary staff in the requirements for pathology, laboratory, radiation therapy submissions mandated by protocols-maintained a good working relationship with those departments so those protocol requirements would be prompt and accurate. Served as an additional resource to patient to answer questions regarding study participation. Completed and submitted on-study forms and other required documents for each patient entered on study according to protocol mandated time frame which included: mandatory submissions such as pathology specimens or blood samples; coordinated shipments with ancillary departments, and/or took direct responsibility for preparation and shipping so those specimens were viable upon receipt at final destination. Submitted all appropriate treatments forms, toxicity forms, measurement forms, etc. as specified by protocol and within the time frame specified by the protocol. Submitted off-treatment data at the appropriate time, as required by protocol: Long-term survival follow-up required extensive time acquiring medical records from other physician offices, patient and/or family contact, or correspondence with regulatory agencies to acquire knowledge about the patient's survival status.