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Work Background
Sr. Clinical Research Associate - Hematology/Oncology/CAR T / Regional Site Mgr.
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.
Senior Clinical Research Associate - Hematology/Oncology
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.
Clinical Research Associate - Hematology/Oncology
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.
Clinical Research Associate - Hematology/Oncology
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.
Clinical Research Coordinator / Research Nurse
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.
Clinical Research Coordinator / Research Nurse
Alexian Brothers Center for Psychiatric ResearchClinical Research Coordinator / Research Nurse
Feb. 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.
Registered Nurse - Psychiatric
Alexian Brothers Behavioral Health HospitalRegistered Nurse - Psychiatric
Mar. 2012 - Feb. 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.
Registered Nurse
ClearbrookRegistered Nurse
Feb. 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.
Registered Nurse
Maryville Children's Healthcare CenterRegistered Nurse
Feb. 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.
Medical Technologist
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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