Summary
Overview
Work History
Education
Skills
Timeline
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Adeola Odusanya

Perth Amboy,NJ

Summary

A Clinical Research Associate with considerable experience within the CRO and Pharmaceutical environment with strong clinical educational background and experience in engaging clinical trial environments and systems. Attentive and progressive experience with various electronic platforms and office systems − EDC (Oracle Clinical Remote Data Capture, and Medidata Rave) and CTMS (IMPACT and LOTUS).

Key therapeutic experiences are within neurology , immunology, , dermatology,urology, Mild Depression Disorder. Seeking to attain a position to advance my career and provide efficient and quality service. Conduct all activities according to the defined project-specific quality and performance standards, as well as relevant SOPs, ICH/GCP, and local requirements. Ensure quality and integrity of data, compliance with SOPs, ICH GCP guidelines, and regulatory requirements. Strong expertise in computer literacy and clinical trial management systems.

Overview

10
10
years of professional experience

Work History

Senior Clinical Research Associate

ICON PLC
03.2020 - Current
  • Serve as a leader and mentor to other CRAs in all aspects of the CRA role
  • Represent RAD and region at management meetings or other meetings as assigned and participate in decisions made at assigned meetings (e.g
  • Site selection, site issue resolution)
  • Assist with performance evaluation and management of CRAs
  • Manage assigned study sites and networks conducting phase I-IV protocols according to the monitoring plan including source document verification
  • Ensure the site Investigator Folder is up to date and mirrors the ICON VeevaVault TMF
  • Responsible for collecting regulatory documents from site and filing in the ICON TMF
  • Prepare and collect study site documents
  • Perform Initiation Visit and continue to train study personnel as needed on study protocol, procedures, study drug handling and storage, CRF completion, SAE reporting, GCP, and possibly the drug mechanism
  • Monitor site drug supply, storage, accountability documentation
  • Perform interim and final drug return
  • Coordinate timely shipment of clinical supplies and study drug to sites
  • Ensure proper storage, dispensation and accountability of clinical supplies and study drug
  • Maintain adequate site tracking records
  • Follow up of drug safety issues and safety reports in timely manner, if applicable.

Senior Clinical Research Associate

Novartis Pharmaceutical
08.2016 - 03.2020
  • Support the goals of the GenMed organization by initiating, monitoring, and closing out clinical study sites following GCP and ICH guidelines as well as Novartis SOPs and ensuring that study milestones are met
  • Central point of communication between Novartis and investigational sites for all clinical trial related activities
  • Mentor to CRAs
  • Trial Lead CRA role for a trial when assigned
  • Key areas of Responsibility:
  • Serve as a leader and mentor to other CRAs in all aspects of the CRA role
  • Represent RAD and region at management meetings or other meetings as assigned and participate in decisions made at assigned meetings (e.g
  • Site selection, site issue resolution)
  • Assist with performance evaluation and management of CRAs
  • Manage assigned study sites and networks conducting phase I-IV protocols according to the monitoring plan including source document verification
  • Ensure the site Investigator Folder is up to date and mirrors the Novartis TMF
  • Responsible for collecting regulatory documents from site and filing in the Novartis TMF
  • Prepare and collect study site documents
  • Perform Initiation Visit and continue to train study personnel as needed on study protocol, procedures, study drug handling and storage, CRF completion, SAE reporting, GCP, and possibly the drug mechanism
  • Conduct feasibility and screen potential Investigators and networks to evaluate their capabilities for conducting clinical trials
  • Nominate sites to participate in studies in con- junction with Medical Science Liaison and Clinical Research Medical Advisor colleagues
  • Responsible for utilizing and updating electronic systems to perform job functions (e.g
  • Outlook, WinFx, ClinTransfer, IMPACT, IWS, eTMF, webEDI, I.MAN, STARS, Vantage, SSU Database, Investigator Portal, LMS, ESOPs, iLearn, Expense reimbursement, CWT Horizon, Metrixx, Timecard, PMP, multiple eCRF applications)
  • Serve as a reference to other CRAs on electronic systems
  • May be responsible for assisting with the evaluation, design and implementation of new systems
  • Ensure that study milestones are met as planned (i.e
  • Database analyses, study startup, recruitment, closeout, etc.)
  • Ensure Unblinded study team processes are in place and training is developed and delivered
  • Track and document potential/actual unblinded event to completion
  • Assist in Risk Based Monitoring review and analysis related to protecting study unblinding
  • Monitor site drug supply, storage, accountability documentation
  • Perform interim and final drug return
  • Review Unblinded Site Monitoring Visit Reports and review randomization and/or IVRS specifications and ensure system accuracy and process compliance
  • Enforce and follow GCP and ICH requirements as appropriate
  • Prepare study monitoring reports, per Standard Operation Procedures (SOPs) and applicable regulations
  • May review and approve monitoring reports of junior CRAs as assigned
  • Manage data query resolution process with sites and track status updates (i.e
  • IWS)
  • Perform Site Closeout activities per SOPs and applicable regulations
  • Travel domestically (and possibly internationally) as needed to study sites and for training and meetings
  • A minimum of 50% overnight travel may be required
  • Attend and participate in disease indication and project specific training and general CRA training as required
  • Perform additional roles and functions for GenMed Clinical Operations as assigned such as a trial Lead CRA, systems super user, or committee member
  • Support the successful implementation of innovative processes and technologies.

Senior Clinical Research Associate

Inventive Health
10.2015 - 04.2016
  • Assist with the development of study manuals, annotated CRFs, monitoring conventions, tracking forms, site study tools, and other study materials;
  • Develop and implement innovative approaches for and participates in site recruitment, selection and initiation activities
  • Assist with investigator meeting activities including organization, preparation and attendance
  • Conduct site management activities, including but not limited to site selection visits, site initiation visits, site training, site routine monitoring visits, and site close out visits
  • Ensure the integrity of clinical data and adherence to applicable regulatory, protocol, and company guidelines
  • Establish and maintain good rapport with study sites
  • Write study visit reports and follow up letters within the timeline established by applicable SOPs and guidelines
  • Coordinate timely shipment of clinical supplies and study drug to sites
  • Ensure proper storage, dispensation and accountability of clinical supplies and study drug
  • Maintain adequate site tracking records
  • Conduct and assist with administrative activities as a member of the project team
  • Mentor for Site Manager, when assigned
  • Conduct on the job training and formal training to other CRAs and Clinical Trials Assistants
  • Collaborate with Regional Monitoring Manager or Clinical Operations Manager /study teams to resolve site issues
  • Review study visit reports, follow-up letters and site communication generated by other CRAs for timeliness, quality, consistency, and appropriate documentation and resolution of issues, with support from Clinical Team Lead, Regional Monitoring Manager or Clinical Operations Manager as needed
  • Participate in routine study progress meetings, face to face or via teleconference.

Regional Clinical Research Associate III

PAREXEL International
11.2012 - 10.2015
  • Conduct the remote clinical monitoring aspect of designated projects
  • Build relationships with investigators and site staff remotely
  • Perform remote clinical monitoring activities (issue resolution, patient enrollment management, handling protocol- and/or ICF- and/or contract amendments, drug / supply management and ensuring timely data entry at a site level)
  • Update all relevant tracking system on an ongoing basis, including the maintenance of site staff details
  • Serve as primary in-house site support by conducting outbound and receiving inbound calls from study sites to:
  • Review recruitment plan and enrollment updates
  • Address/resolve issues pending from the previous visit
  • Address protocol questions
  • Check on site staff assignment
  • Assess drug/study supply status
  • Request outstanding documents
  • Review site payment status
  • Follow-up on data entry, query status and SAEs
  • Follow-up on appropriate site related questions
  • Ensure proper storage, dispensation and accountability of clinical supplies and study drug
  • Maintain adequate site tracking records
  • Follow up of drug safety issues and safety reports in timely manner, if applicable
  • Assist with data query form (incl
  • Query process)
  • Perform telephone monitoring activities in order to obtain study status information
  • Development and implementation of corrective actions when appropriate
  • Prepare /review all patients tracking records
  • Input and maintain study information concerning subject status of financial reimbursement to sites
  • Conduct and assist with administrative activities as a member of the project team
  • Mentor for Site Manager, when assigned
  • Conduct on the job training and formal training to other CRAs and Clinical Trials Assistants
  • Collaborate with Regional Monitoring Manager or Clinical Operations Manager /study teams to resolve site issues
  • Participate in routine study progress meetings, face to face or via teleconference
  • Conduct site management activities, including but not limited to site selection visits, site initiation visits, site training, site routine monitoring visits, and site close out visits

Education

Bachelor of Arts - Chemistry And Mathematics

Hunter College of The City University of New York
New York, NY
06.2002

Skills

  • THERAPEUTIC AREAS
  • Urology- Idiopathic Overactive Bladder, Benign Prostatic Hyperplasia
  • Dermatology-Moderate to Severe Acne, Psoriasis
  • Ophthalmology- Corneal Hypoesthesia, Dry eyes
  • Neurology- Post Herpetic Neuralgia, Depression,
  • Cardiovascular-Congestive Heart Failure, Coronary Heart Spasm
  • Oncology- Non Small Lung Cancer, Renal Clear Cancer, indolent Non Hodgkin Lymphoma, Multiple Myeloma, Chronic Lymphocytic Leukemia
  • Central Nervous System- Alzheimer Disease

Timeline

Senior Clinical Research Associate

ICON PLC
03.2020 - Current

Senior Clinical Research Associate

Novartis Pharmaceutical
08.2016 - 03.2020

Senior Clinical Research Associate

Inventive Health
10.2015 - 04.2016

Regional Clinical Research Associate III

PAREXEL International
11.2012 - 10.2015

Bachelor of Arts - Chemistry And Mathematics

Hunter College of The City University of New York

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Adeola Odusanya