Seeking to obtain a clinical Research Position where my skills and experience in sight monitoring and management will be used to support clinical trials.
Overview
6
6
years of professional experience
Work History
Clinical Research Associate
ALKU
03.2022 - Current
Monitor assigned clinical trials to ensure sponsor and investigator obligations are being met and that sites are in compliance with protocol, applicable local regulatory requirements and ICH guidelines
Support the investigator selection process through site identification, evaluation, pre-study visits and feasibility studies of sites
Participate in the study start up activities and performed a range of tasks including budget/contract development and negotiations, site initiation visits, and GCP Instruction to Investigators/Research Personnel
Ensure that Serious Adverse Events are reported to the sponsor and IRB in a timely manner and that adverse events are documented in the source documents and CRFs.
Performed ongoing site monitoring visits to conduct source data verification, drug accountability, query generation and resolution, SAE verification and reporting oversight regulatory file review and oversight, document submission for central archiving, monitor reports, general site support and communication
Train and re-train new research personnel, including Study Coordinators, Investigators, and site pharmacists as required during the study
Work closely with other team members to ensure timely resolution of project and/or clinical issues and obtain direction from more senior clinical operations staff.
Study Coordinator
Torrance Memorial Medical Center
09.2019 - 03.2022
Organized and managed documentation related to clinical studies including protocols, consent forms, case report forms, investigator brochures, amendments
Ensured adherence to federal regulations regarding human subject protection during clinical trials
Participated in planning meetings with sponsors and CROs to discuss objectives of upcoming studies
Performed blood draws, ECGs, breathing tests, vital signs, etc
Submitted and managed study data for pharmaceutical sponsors
Reviewed and processed medical records
Performed study procedures and collected data from patients participating in a clinical trial.
Certified Nursing Assistant
Torrance Memorial Medical Center
12.2017 - 08.2019
Served as an advocate for each patient's needs during shift handoffs or interdisciplinary conferences with other healthcare professionals
Actively participated in interdisciplinary team meetings to discuss patient progress and develop effective care strategies
Checked patient vitals such as temperature, blood pressure, and blood sugar levels
Streamlined communication between nursing staff, patients, and families to ensure comprehensive understanding of care plans.
Utilized therapeutic communication, empathy and active listening skills to encourage and develop positive relationships with patients.
Documented patient information and care activities in electronic health record.
Followed directions of licensed nurses to administer medications and treatments.
Education
Bachelor of Science (B.S.) in Nursing -
Charles.R. Drew University of Medicine and Science
Los Angeles, CA
05.2024
Associate in Arts (A.A.) in Nursing -
Los Angeles Southwest College
Los Angeles, CA
01.2021
Bachelor of Arts (B.A.) in Industrial and Labor Relations -
Olabisi Onabanjo University
Ogun State, Nigeria
05.2012
Skills
Knowledge of ICH GCPs and the FDA regulations
Excellent oral and written communication skills
Knowledge of data recording and management
Sound analytical skills and detail-oriented
Great Interpersonal skills
Immense multi-tasking capability
Responsible for continued career development and training
Extensive knowledge of clinical trial process
Excellent organization, planning and problem solving abilities
Vast exposure to different clinical trial systems and tools (CTMS, EDC, IVRS, etc)
Timeline
Clinical Research Associate
ALKU
03.2022 - Current
Study Coordinator
Torrance Memorial Medical Center
09.2019 - 03.2022
Certified Nursing Assistant
Torrance Memorial Medical Center
12.2017 - 08.2019
Bachelor of Science (B.S.) in Nursing -
Charles.R. Drew University of Medicine and Science
Associate in Arts (A.A.) in Nursing -
Los Angeles Southwest College
Bachelor of Arts (B.A.) in Industrial and Labor Relations -