Summary
Overview
Work History
Education
Certification
Therapeutic Expertise
Timeline
Generic

Eliza Ese

Phoenix

Summary

Dedicated Senior Clinical Research Associate, successful at evaluating sites, initiating trials, and managing closeouts. Experienced with Phase I–IV trials and successful at adapting to new processes. I bring excellent organizational, planning, and interpersonal skills gained during my career. Seasoned Senior Clinical Research Associate with a background in managing and overseeing clinical trials. Strengths include thorough knowledge of clinical trial protocols, patient interaction, data management, and regulatory compliance. Previous roles have demonstrated strong leadership skills, efficiency in monitoring activities related to clinical studies, and the ability to maintain high-quality standards for all research projects. Proven track record of significant contributions towards improving processes and streamlining workflow within previous organizations.

Overview

12
12
years of professional experience
1
1
Certification

Work History

Senior Clinical Research Associate

Bristol Myers Squibb
04.2021 - Current
  • Anticipated, recognized, and resolved issues in the assigned study sites.
  • Performed all site monitoring visit activities, including all study visit types (PSV, SIV, IMV, and COV).
  • Verifies Serious Adverse Event (SAE) reporting according to trial specifications and ICH-GCP guidelines.
  • Mentors junior-level CRAs and serves as a resource for new employees.
  • Implements and monitors clinical trials to ensure that sponsor and investigator obligations are met, and comply with applicable local regulatory requirements and ICH-GCP guidelines.
  • Assess the qualifications of potential investigative sites, initiate clinical trials at investigative sites, and instruct site personnel on the proper conduct of clinical trial data collection, either on-site or remotely.
  • Reviews and verifies the accuracy of clinical trial data collected, either on-site or remotely.
  • Provides regular site status information to team members, trial management, and updates to trial management tools.
  • Works closely with other clinical team members to facilitate the timely resolution of trial and/or clinical issues.
  • Performs source document verification and query resolution.
  • Ensured the integrity of the data submitted on Case Report Forms (CRFs) or other data collection tools by carefully reviewing source documents and monitoring for missing or implausible data.

Senior Clinical Research Associate

Amgen
07.2018 - 04.2021
  • Led Phase II/III site monitoring for cardiovascular and neurology trials across the U.S. sites.
  • Delivered high-quality data through detailed source reviews, AE/SAE reporting, and IP accountability.
  • Conducted regulatory submissions, coordinated SIVs and monitoring visits, and ensured GCP compliance.
  • Reviewed regulatory documentation/files at the site for completeness, and collected updated forms as applicable.
  • Reviewed protocol violations with investigators, and implemented corrective actions to ensure future compliance with the protocol and applicable regulations (FDA, GCP, ICH, IRB).
  • Controlled trial supplies ordering, dispatch, return, and destruction, as applicable.
  • Ensured that proper, essential documents were in place before trial start-up, and on an ongoing basis throughout the study, as part of the continuous file audit review process.
  • Conducted and ensured proper trial closeout and retrieval of trial materials, as per the Monitoring Plan.
  • Maintained frequent telephone contact and/or email contact with the study team and the investigative sites to ensure prompt resolution of any issues, and to fulfill the requirements of the contract.
  • Monitored safety events reported by investigators or found during monitoring visits.

Clinical Research Associate

PPD
06.2015 - 07.2018
  • Conducted pre-study, initiation, monitoring, and closeout visits for research sites, and prepared required documentation.
  • Conducted site initiation visits, trained site personnel on sponsor and regulatory requirements for study conduct, participated in and/or conducted site meetings, and prepared site initiation visit reports and associated documentation.
  • Conducted site monitoring visits and follow-ups to identify significant problems and issues, and to ensure that all clinical aspects of the studies are being carried out in accordance with the study.
  • Partnered with cross-functional teams (e.g., clinical data management, medical teams) for query management, data reviews, and resolution.
  • Conducted reviews of documentation needed for internal and external audits to ensure all essential Clinical Trial Master File (TMF) documents are compliant with Good Documentation Practices, SOPs, and U.S. regulations.
  • Delivered technical training on GCPs, protocols, database, compliance, device accountability, adverse event reporting, study investigation protocols, amendments, and regulatory documentation requirements, as well as training and proctoring new employees on trial and study-related activities.
  • Verified trial/study data, including maintaining appropriate regulatory documents, both internal and external, auditing to ensure the site has the appropriate regulatory documentation to conduct the trial/study, and ensuring that source documentation is properly recorded.
  • Performed adverse event (AE) and serious adverse event (SAE) reporting and follow-up.
  • Assessed patient recruitment and retention. Performed onsite pre-study, initiation, interim, and close-out monitoring visit activities as assigned to ensure facilities are adequate, investigative site staff are adequately qualified, and the site's activities are in compliance with the clinical trial protocol and all applicable governmental and regulatory/ethics regulations.

Clinical Research Coordinator

Cleveland Clinic
05.2013 - 06.2015
  • Interacted and collaborated with sponsors, performance sites, local IRB, Office of Sponsored Research, or Clinical Trials Office to address operational and logistical issues as needed to ensure the successful conduct of clinical trials.
  • Assisted Principal Investigators with the management of study activities, including assisting in the coordination of conference calls, preparation of a quarterly newsletter, and interfacing with the data management team and performance sites.
  • Ensured that schedules, follow-up, and completion of research protocols progress as planned. Works with staff to resolve day-to-day problems.
  • Implemented the process of protocol for various clinical trials; coordinated sponsor-conducted initiated visit(s); assisted in the execution of new IRB applications, and processed annual reviews for the IRB committee regarding consent.
  • Collaborated with the PI and/or Research Nurse in the submission of protocols, amendments, notices, suspensions, and terminations to the IRB for review and approval.
  • Interacted with patients prior to entering the study and throughout the entire treatment. Monitored the occurrence of adverse events and reported them according to the guidelines of the FDA, the sponsoring drug company (if applicable), and the IRB.
  • Supported and corresponded with investigative sites as necessary, including ordering study drugs and other trial-related supplies.

Education

B.S. - Public Health

Southern New Hampshire University
04.2023

B.S. - Biomedical Science

South Africa
06.2013

Certification

  • ACRP Certified Professional
  • Valid Driver’s License | 80% Travel-Ready

Therapeutic Expertise

  • Cardiovascular: Pulmonary Hypertension, ARDS
  • Immunology: Rheumatoid Arthritis, Psoriasis
  • Oncology: Breast, Colorectal, Lung Cancer, Non-Hodgkin Lymphoma
  • Neurology: Parkinson’s, Alzheimer’s, Multiple Sclerosis
  • Dermatology: Atopic Dermatitis, Eczema, Palmoplantar Pustulosis
  • Ophthalmology & Infectious Diseases

Timeline

Senior Clinical Research Associate

Bristol Myers Squibb
04.2021 - Current

Senior Clinical Research Associate

Amgen
07.2018 - 04.2021

Clinical Research Associate

PPD
06.2015 - 07.2018

Clinical Research Coordinator

Cleveland Clinic
05.2013 - 06.2015

B.S. - Public Health

Southern New Hampshire University

B.S. - Biomedical Science

South Africa

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Eliza Ese