Summary
Overview
Work history
Education
Skills
Languages
Timeline
Generic

Carole Aramide

Chatham,Kent

Summary

A Clinical Research professional with years of experience in several positions as a clinical Research Associate and as a Clinical Trial Administrator, A Thorough Knowledge of ICH-GCP guidelines, clinical monitoring experience in phase II and III clinical trials and monitoring procedures obtained in current and previous roles on various multi-site clinical trials.

I have been involved in performing OMV, Remote Monitoring, SIV,COV, management of SDV, management of IMPs, participant consent, pharmacy and investigator site file review, query resolution and processing.


THERAPEUTIC EXPERIENCE:

Therapeutic Area Indication Phase SItes Type


Respiratory Pneumonia III 4 SIV, IMV

Infectious Disease Hepatitis B Virus II 5 IMV

Cardiovascular Hypertension II 3 IMV, COV

Oncology Prostrate II 4 IMV

Overview

15
15
years of professional experience

Work history

SCRA (Part-time)

PHARMALYS
London
09.2022 - Current
  • Perform routine site visits, including Pre-study, Initiation, Routine, and closeout visits, to include monitoring of informed consent procedures compliance with protocol, GCP/ICH guidelines, and other applicable regulatory requirements, and assurance of good site performance.
  • Document each visit with an effective monitoring visit report and submit to the reviewer for review and approval within contractual timeless.
  • Authoring and sending follow up letter to investigative site documenting the visit and outstanding topics to be addressed within contractual timelines.
  • Develop study specific tools for tracking and report for project managers.
  • Assist project management team with review of study documents when required.
  • Participate in company-required training programs.

SCRA

IQVIA
London
03.2022 - 09.2022
  • Responsible for all aspects of study site monitoring including conduct or pre-study and initiation, routine monitoring and close-out of clinical sites, maintenance of study files, site payment etc.
  • Identified, selected, initiated, and closed-out appropriate investigational sites for clinical studies with UK and Ireland.
  • Developed study forms, tools and assisted in development of SOPs.
  • Worked with sites to adapt , drive, and track subject recruitment plan, Co-monitoring, training, and mentoring of junior members in the team.
  • Provided protocol and study training to assigned sites, create and maintain monitoring visit reports and action plans, Ensure the study staff who will conduct the protocol have received the proper materials and instructions to safely enter patients into the study.
  • Responsible for developing, Maintaining, and tracking study budgets and financial reporting, including invoice and PO management/reconciliation, accrual tracking and reporting, and re-forecasting.
  • Oversees and tracks study status and timelines, and feeds data into performance metrics reporting for assigned clinical projects.
  • Participated in development of clinical study documents including ICF, Monitoring plans, recruitment plans, and other program/study related documents.

SCRA

Pharmalys
London
06.2021 - 03.2022
  • Perform routine site visits, including Pre-study, Initiation, Routine and closeout visits, to include monitoring of informed consent procedures, compliance with protocol, GCP/ICH guidelines, and other applicable regulatory requirements and assurance of good site performance.
  • Document each visit with an effective monitoring visit report and submit to the reviewer for review and approval within contractual timelines.
  • Develop study specific tools for tracking and report for projects managers.
  • Participate in feasibility studies.
  • Presenting study materials at investigator/study launch meetings when required.

SCRA

Jansen(ICON)
London
08.2020 - 04.2021
  • Conducting remote and onsite monitoring, initiation and site closure visits in accordance to study protocol.
  • Ensuring all site visit activities are performed in adherence to ICH-GCP standards.
  • Conducting site feasibility assessment to assess investigational site facilities.
  • Conducting source data review and verification as required per study monitoring plan/guideline.
  • Ensuring all SAE/AE reporting are within reporting timelines and are in accordance with the trial specifications.
  • Performing study IMP accountability and reconciliation to ensure all site IMP are appropriately handled, and accurately inventoried.
  • Performing routine ISF review and reconciling all documents with the TMP in preparation for inspection readiness or audit review.

CRA

Navitas
London
08.2018 - 08.2020
  • Perform routine site visits, including Pre-study, Initiation, Routine, and closeout visits, to include monitoring of informed consent procedures, compliance with protocol, GCP/ICH guidelines, and other applicable regulatory requirements, and assurance of good site performance.
  • Document each visit with an effective monitoring visit report and submit to the reviewer for review and approval within contractual timelines.
  • Develop study specific tools for tracking and report for projects managers.
  • Participate in feasibility studies.
  • presenting study materials as investigatory/study launch meetings when required.
  • perform necessary administrative functions (e.g.) submission of expense reports.

CTA, Lead CTA

CDR
London
06.2011 - 08.2018
  • Assisted Clinical Research Associates and Regulatory study start-up with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.
  • Assisted the clinical team in the preparation, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures.
  • Assisted with periodic review of study files for completeness.
  • Assisted CRAs and RSU with preparation, handling and distribution of clinical trial supplies and maintenance of tracking information.
  • Assisted with tracking and management of case report forms (CRFs), queries and clinical data flow.
  • Acted as a central contact for the team for designated project communications, correspondence, and associated documentation.
  • Accompanied CRAs on site visits to assist with clinical monitoring duties upon completion of required training and with required approval.
  • Performed assigned administrative duties to support team members with clinical trial execution.

Project Support Officer

London Independent Hospital
London
05.2008 - 06.2011
  • Provided high quality reports which include project status, executive summary report, project gate, milestones on all aspects of the FM.
  • Supported the program Manager and Team Managers in the production and maintenance of project plans.
  • Developed and maintaining the project library, filing, recording, and reporting system, documenting procedures in accordance with agreed methodology.
  • Updated and maintained the risk, Action and issue and dependency Logs (RAID Log), making sure that risks and issues are assigned for mitigating actions. Review actions and chase owners for completion.
  • Liaised with the finance and project managers to ensure that project is within budget, checking forecasts versus actuals and ensuring variance is justified.
  • Supported project managers on identifying, documenting, and managing inter-project dependencies and controlled all project dependencies, issues, and risks.
  • Met daily with project team to review project plans and status, preparing meeting agendas and taking meeting minutes as required, distributing minutes to attendees.
  • Managed SharePoint site i.e. granting access / permissions and ensuring docs are stored in the correct location.

Education

Bachelor of Science - Biochemistry

Ogun State University
Nigeria

Bachelor of Science - Management

Greenwich School of Management
London

CRA Academy
United State

Skills

  • Over 3 years experience of site management and Monitoring of clinical trials
  • Experience monitoring global studies (Phases II & III) from site initiation to maintenance phase and close-out
  • Good Knowledge of ICHG CP guidelines, MHRA, Ethics committee & HRA
  • Strong leadership and interpersonal skills
  • Excellent Oral and written communication skills
  • Excellent self-management, Organizational skills and detailed oriented
  • Computer skills: MS Word, Outlook, Excel, PowerPoint, Access, OneNote
  • Proficient in the usage of: EDC-Medidata Rave, Inform, CTMS, IWRS-Bracket, Cenduit & BioClinica, eTMF-Veeva Vault

Languages

English
Beginner

Timeline

SCRA (Part-time)

PHARMALYS
09.2022 - Current

SCRA

IQVIA
03.2022 - 09.2022

SCRA

Pharmalys
06.2021 - 03.2022

SCRA

Jansen(ICON)
08.2020 - 04.2021

CRA

Navitas
08.2018 - 08.2020

CTA, Lead CTA

CDR
06.2011 - 08.2018

Project Support Officer

London Independent Hospital
05.2008 - 06.2011

Bachelor of Science - Biochemistry

Ogun State University

Bachelor of Science - Management

Greenwich School of Management

CRA Academy

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Carole Aramide