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Work Background
inSeption GroupSr. Clinical Research Associate - Hematology/Oncology/CAR T / Regional Site Mgr.
Mar. 2023Chicago, Illinois, United States• Managing key deliverables for inSeption Group and their stakeholders, including study activities, timelines, and schedules on the country level. • Serving as Lead CRA while managing groups of 2-5 co-monitors, including scheduling, organization of workload, compilation of findings, and execution of trip reports.
• Overseeing management, communication, and integrity of the study at assigned sites; serving as a key liaison for the study sponsor and team by fostering excellent relationships with site PI and staff. • Actively ensuring the rights, safety, and well-being of patients in accordance with the study protocol and ICH-GCP requirements.
• Executing hands-on activities from study concept to study closeout, including: - Site Identification, Qualification, and Selection - Site Start-Up Essential Document Review and Approval (ICH-GCP Guidelines) - Site Initiation, Training, and Activation - Site Screening and Enrollment - Interim Monitoring & Regulatory Review – Remote and Onsite visits. - Site Closeout • Proactively managing the collection and reporting of quality and timely data collection, query resolution, reporting of protocol deviations, and SAEs/AESIs. Escalating any issues, as appropriate.
• Monitoring of eCRFs, source data, and query resolution. Ensuring completion and reconciliation of the Investigator Site File and Trial Master File. Comprehensive recording of visit findings via written reports.
• Tracking Biologic samples, as well as managing receipt, storage, handling, dispensing, resupply, and destruction of all site supplies, as needed. • Generating and analyzing site metrics reports; identifying and reporting any trends identified.
• Implementing all written plans provided by the study team toward the management of the sites.
• Serving as a trainer and mentor for junior staff.
ICON plcSenior Clinical Research Associate - Hematology/Oncology
Aug. 2021 - Mar. 2023United States- Overseeing study start-up, site initiation, interim monitoring, and close-out activities for Phase I-III Oncology studies. - Proven record of effectively meeting timelines and exceeding expectations of leadership as Lead CRA of a team tasked by the Sponsor with reviewing study conduct, data reporting, and data monitoring of a study due to an excessive backlog of data entry and review from previous CRO. - Reviewing the performance of studies at assigned sites ensuring the rights and well-being of patients are protected in accordance with the protocol.
- Ensuring accurate and timely reporting of data, query resolution, reporting of protocol deviations, and SAEs/AESIs. Escalating issues, as appropriate.
- Ensuring compliance with standard operating procedures, protocol/amendments, GCP and the applicable regulatory requirements, and completeness and quality of the electronic Trial Master File.
IQVIAClinical Research Associate - Hematology/Oncology
Aug. 2020 - Aug. 2021Chicago, Illinois, United States- Overseeing study start-up, site initiation, interim monitoring, and close-out activities for Phase I-III Oncology studies. Reviewing the performance of studies at assigned sites ensuring the rights and well-being of patients are protected in accordance with the protocol.
- Ensuring accurate and timely reporting of data, query resolution, reporting of protocol deviations, and SAEs/AESIs. Escalating issues, as appropriate.
- Ensuring compliance with standard operating procedures, protocol/amendments, GCP and the applicable regulatory requirements, and completeness and quality of the electronic Trial Master File.
Syneos HealthClinical Research Associate - Hematology/Oncology
Mar. 2018 - Jul. 2020North Chicago, Illinois- Overseeing study start-up, site initiation, interim monitoring, and close-out activities for Phase I-IV Oncology studies. Reviewing the performance of studies at assigned sites ensuring the rights and well-being of patients are protected in accordance with the protocol.
- Ensuring accurate and timely reporting of data, query resolution, reporting of protocol deviations, and SAEs/AESIs. Escalating issues, as appropriate.
- Ensuring compliance with standard operating procedures, protocol/amendments, GCP and the applicable regulatory requirements, and completeness and quality of the electronic Trial Master File.
Advocate Medical Group Oncology (Previously Oncology Specialists, SC)Clinical Research Coordinator / Research Nurse
Nov. 2015 - Mar. 2018Park Ridge, IllinoisServing as a Clinical Research Nurse Coordinator at a thriving community Oncology practice, (acquired by Advocate Medical Group). Performing all duties related to clinical trials coordination, including: intense knowledge of numerous complex oncology protocols involving solid tumors or hematologic malignancies; all procedures from start-up to closeout.
Alexian Brothers Center for Psychiatric ResearchClinical Research Coordinator / Research Nurse
Mar. 2014 - Oct. 2015Hoffman Estates, IL• Coordinating patient care for those participating in inpatient and outpatient clinical research trials.
• Maintaining accurate clinical data and documentation, providing ongoing nursing assessments and patient teaching, maintaining study drug accountability, and maintaining communication with all members of the clinical trials team.
Alexian Brothers Behavioral Health HospitalRegistered Nurse - Psychiatric
Mar. 2012 - Mar. 2014Hoffman Estates, IL• Providing for the medical and psychiatric needs of adult clients in an acute-care inpatient setting, including meeting the diverse needs of clients with bipolar disorder (manic and depressive phase), schizophrenia, psychosis, suicidal/homicidal ideation, substance abuse, eating disorders, self-injurious behavior, and various mood disorders. • Serving as Charge Nurse for a team of 2-6 staff members, working together to manage a safe, therapeutic milieu. Providing safe medication administration.
• Utilizing CPI principles to provide for patient safety. Safe utilization of physical and mechanical restraint, when necessary.
• Maintaining a positive, therapeutic relationship with patients in a clinical setting, as demonstrated by a supportive, genuine, understanding, respectful, and empathic role in the care of clients.
• Utilizing the nursing process to assess the mental and physical health needs of our clients, and developing a plan of care based on nursing diagnoses.
• Educating clients to enable them to be active in their own care, and to understand the role of medication within that plan of care.
ClearbrookRegistered Nurse
Mar. 2011 - Apr. 2012Arlington Heights• Providing and coordinating medical care for developmentally disabled adult clients in a 92-bed intermediate care facility. • Serving as Charge Nurse for overnight shift, supervising clients and support staff.
• Utilizing the nursing process to provide quality nursing care and case management for clients in a fast-paced environment.
• Nursing management of the diverse behavioral and mental health needs of the clients.
Maryville Children's Healthcare CenterRegistered Nurse
Mar. 2011 - Nov. 2011Chicago, IL• Providing long-term acute and specialized clinical care for medically fragile children, ages newborn through 21, who may be technology dependent (e.g. ventilators, apnea monitoring). • Providing training for parents, caregivers, and siblings to help them become more confident when attending to the fragile child's specialized needs.
Clinical Microbiology LabMedical Technologist
Jul. 1995 - Dec. 2010Various• Served as a Microbiologist, as well as a generalist in Blood Bank, Hematology, and Chemistry, for several area hospitals, including Children’s Memorial Hospital, Loyola University Medical Center, West Suburban Medical Center, and MacNeal Hospital.
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