Summary
Overview
Work History
Education
Skills
Websites
Accomplishments
Timeline
Generic

Adelana Tade

Avon

Summary

Experienced Senior CRA III who has performed monitoring and site management activities in several therapeutic areas including Oncology with Indications in Lung Cancer, Multiple Myeloma, Acute Myeloid Leukemia and Solid Tumor, as well as Neurology, with indications in Schizophrenia, Huntington Disease, Dementia and Parkinson Disease for phase I-III clinical research projects. I have also participated in a Long-Time -Follow-Up study (post marketing phase) where I accessed the progress of clinical projects at assigned investigative/physician sites, ensuring clinical projects are conducted, recorded, and reported in accordance with the protocol, company and sponsors standard operating procedures (SOPs) & ICH-GCP. Therapeutic Summary Experienced Senior CRA III who has performed monitoring and site management activities in several therapeutic areas including Oncology with Indications in Lung Cancer, Multiple Myeloma, Acute Myeloid Leukemia and Solid Tumor, as well as Neurology, with indications in Schizophrenia. Oncology (5 years): Lung 5 Phase III, Multiple Myeloma 3 Phase I/II, Lymphoma 3 Phase I/III, Multiple solid tumors dose finding and Escalation Phase II. Neurology/CNS (3 Years): Schizophrenia Phase I/II, Huntington Disease Phase I/II, Parkinson Disease phase III Infectious Diseases (3 Years) Flu Phase III. Rare Disease (2 Years) Cystic Fibrosis Phase III. Medical devices (3years): Heart value, CGDM, IVD Cardiovascular (2.5yrs): Hypertension and Myocardial Infraction.

Equipped with strong problem-solving abilities, willingness to learn, and excellent communication skills. Poised to contribute to team success and achieve positive results. Ready to tackle new challenges and advance organizational objectives with dedication and enthusiasm.

Overview

9
9
years of professional experience

Work History

CRA III

Worldwide Clinicals
01.2022 - Current
  • Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
  • Followed drug storage procedures to comply with protocols and SOP requirements.
  • Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents, and data completion.
  • Traveled to investigative sites to conduct site qualification, initiation, interim monitoring, and close-out visits to maintain and enforce regulatory compliance.
  • Performs study initiation activities, Interim and study close-out visits while reviewing regulatory documents, as well as provide training on completion of the eCRF to site staffs.
  • Assures adherence to Good Clinical Practices, investigator integrity, and compliance with all study procedures through on-site and remote monitoring visits.
  • Performs study close-out visits per the study specific Clinical Monitoring Plan, including final investigational product reconciliation and disposition, site study file reconciliation, data query resolution through to database lock and resolution of outstanding action items.
  • Reviews the quality and integrity of the clinical data through (1) in house review of electronic CRF data and (2) on-site source verification, while working with sites to resolve data queries
  • Identified adverse events and reports per protocol guidelines.
  • Assisted in the planning and design of source documents for study protocols as required.
  • Provides trial status tracking and progress update reports to the Clinical Team Manager (CTM) as required. Ensures study systems are updated per agreed study conventions (e.g. Clinical Trial Management System, CTMS).

CRA III

Premier Research
07.2018 - 10.2021
  • Presents trial information at Site Initiation Visits or Investigators meetings.
  • Assists in the preparation and follow-up of in-house and on-site sponsored quality audits, as well as regulatory authority inspections.
  • Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
  • Traveled to investigative sites to conduct site qualification, initiation, interim monitoring, and close-out visits to maintain and enforce regulatory compliance.
  • Monitored studies utilizing various EDC systems (Medidata Rave, RDC, Inform) and various reporting systems such as Impact my sites and CTMS.
  • Followed drug storage procedures to comply with protocols and SOP requirements. Assists with development/review of study documents, including clinical trial protocols, ICFs, Case Report Forms (CRFs) and CRF Completion Guidelines, Clinical Monitoring Plan, and lab manuals.
  • Created and maintained database and records filing system to document data on specimen collection, processing, and storage.
  • Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents, and data completion.
  • Interfaced with clinical investigators and site staff to foster ethical research consistent with the protocol.

CRA I

Premier Research
10.2016 - 07.2018
  • Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
  • Followed drug storage procedures to comply with protocols and SOP requirements.
  • Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents, and data completion.
  • Traveled to investigative sites to conduct site qualification, initiation, interim monitoring, and close-out visits to maintain and enforce regulatory compliance.
  • Monitored site proficiency testing and pre-study testing.
  • Ensured sites are familiar and proficient with protocol and study procedures.
  • Executed site close-out monitor and archived all procedure files and data results at each site according to SOP and GCP requirements.
  • Executed site training, including protocol, study SOPs, site files and records, database and date entry requirements, and tested workflow training.
  • Monitored site proficiency testing and pre-study testing.
  • Ensured sites are familiar and proficient with protocol and study procedures.
  • Understood and applied knowledge regarding local, state, and country regulations and industry guidelines.
  • Knowledge of electronic systems e.g., e-CRF, electronic Trial File Master (e-TMF), and Clinical Trial Management System (CTMS).
  • Responsible for attending all required training, study-specific training, and assisting in training of other co-workers

Education

Bachelor of Science - Physics

Ahmadu Bello University
01.2013

Skills

  • Site Investigation Reports
  • Patient Safety
  • Site Visits
  • Product Inventories
  • Study Coordination
  • Schedule Monitoring
  • Monitoring Visits
  • Investigator Meetings
  • Site Selection
  • Time Management
  • Data Integrity
  • Site Safety
  • Regulatory Processes
  • Regulatory Compliance and Documentation

Accomplishments

  • Achieved sponsors recognition in timely query resolution by collaborating withsite in data lock deadlines.
  • Collaborated with team 5 senior CRAs to act as SWAT team for other studies through my ability to multitask.

Timeline

CRA III

Worldwide Clinicals
01.2022 - Current

CRA III

Premier Research
07.2018 - 10.2021

CRA I

Premier Research
10.2016 - 07.2018

Bachelor of Science - Physics

Ahmadu Bello University
Adelana Tade