Summary
Overview
Work History
Education
Skills
Certification
Therapeutic Area of Experience
Timeline
Generic

Oluwatobi Bamgbola

Toronto,Canada

Summary

Experienced Clinical Research Associate bringing more than5 years experience in conducting clinical trials in Oncology, Neurology, Psychiatric Disease, Infectious, Respiratory and Cardiovascular Diseases.

Overview

14
14
years of professional experience
1
1
Certification

Work History

Clinical Research Associate II

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06.2017 - Current
  • Participates in the design and review of clinical trial documents/plans and reports in collaboration with the clinical team
  • Performs assessments and ensures adherence to protocols, procedures and project plans
  • Oversees and coordinates subject recruitment/retention strategy and related initiatives
  • Reviews, tracks and provides guidance on monitoring visit reports from CROs as needed to ensure applicable regulatory and protocol compliance, issue resolutions as well as quality site management and reporting
  • Provides ongoing review and tracking of protocol deviations and issue resolution
  • Reviews and works with CRO team to ensure TMFs remain current throughout the conduct of assigned clinical trials
  • Ensure all essential documentation and communication is maintained as part of the clinical files
  • Reviews data and resolution of queries; assists in data review and the preparation of reports as needed
  • Maintains tracking tools related to study data, contracts, enrollment and clinical materials
  • Support clinical team in all CRO/vendor activities
  • Organizes meetings, and responsible for internal communications
  • Prepares meeting agendas and minutes
  • Prepares presentations in PowerPoint

Clinical Research Associate I

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05.2014 - 06.2017
  • Ensured continued acceptability of the investigator, clinical site team and facility
  • Reviewed clinical data, source documentation, CRF, and investigative site regulatory files
  • Worked closely with data management and site to resolve discrepancies
  • Ensured investigational product accountability accuracy and oversaw investigational product inventory
  • Liaised with vendors such as central laboratories as required to ensure protocol adherence and ensure investigational sites have appropriate clinical supplies
  • Met with clinical study sponsor representatives, as requested
  • Submission of routine monitoring visit reports and follow-up letters as per required timelines
  • Ensured resolution of issues with investigative sites
  • Maintained strictest confidentiality
  • Throughout the conduct of the clinical trial assesses adherence to PRA's SOPS, GCP and all applicable regulatory requirements
  • Conducted all activities according to defined project-specific quality and performance standards as well as relevant standard operation procedures (SOPs), good clinical practices (GCPs) and local requirements
  • Participated in training sessions and workshops by presenting reports from any conferences attended
  • Reported general issues directly to management promptly for efficient problem-solving and resolutions

Clinical Research Coordinator

Sunnybrook Health Sciences Centre
01.2011 - 05.2014
  • Enrolled subjects into the studies
  • Collected initial subject health and demographic information by interviewing subjects and by accessing other appropriate sources
  • Administratively and clinically managed an average of six to eight clinical trials
  • Adhered to Research SOP's
  • Reviewed subject comprehensive medical documentation to determine protocol eligibility under the supervision of the Principal Investigator
  • Provided appropriate community resource referrals to subjects, caretakers, and family members at conclusion of subject's participation in study, as appropriate
  • Adhered to Good Clinical Practices and the study protocols
  • Ensured scientific integrity of data and protect the rights, safety, and well-being of patients enrolled in clinical trials
  • Discussed study protocols with patients and verified the informed consent documentation
  • Provided patient with written communication of their participation (i.e
  • Copy of the signed informed consent)
  • Ensured patient's referring physician received notification of patient's participation in studies as requested by the patient
  • Met with patient for each visit and maintained accessibility to discuss any questions/concerns regarding the study
  • Dispensed study medication in a professional and accountable manner following protocol requirements
  • Collected, processed, and shipped blood/urine specimens at scheduled patient visits
  • Performed ECGs and obtained vital signs of patients
  • Scheduled all patient research visits and procedures consistent with protocol requirements
  • Completed and maintained case report forms per FDA guidelines, and reviewed them against the patient's medical record for completeness and accuracy
  • Administered questionnaires/diaries per protocol
  • Ensured that non-serious and serious adverse events were properly documented and reported in the required timeframe
  • Screened all laboratory results when received and followed protocol procedure regarding abnormal results
  • Ensured all laboratory results were given to appropriate doctors for review of clinical significance, then file results in the patient study binder

Education

Bachelor of Science - Marketing (Minor in Biology)

Osun State Polytechnic

Skills

  • 5 of clinical monitoring experience
  • Excellent knowledge of ICH/GCPs and clinical monitoring procedures
  • Excellent understanding of the therapeutic area for assigned clinical projects
  • Experience using Electronic Data Capture (EDC) and clinical trial management systems
  • Excellent attention to detail and the ability to work individually within a multi-disciplinary team as well as with external partners and vendors
  • Possesses strong written and verbal communication and presentation skills
  • Proven track record of positive site and PI interactions
  • Strong research, analytical, critical-thinking and problem-solving skills
  • Excellent organizational and prioritization skills with the ability to handle multiple tasks and meet deadlines while working independently
  • Effective interpersonal skills: shows confidence with subject matter and a 'calm under pressure' approach and style

Certification

  • CPI-Crisis Prevention Intervention license Canada
  • Certification Dominion College - Toronto, Canada
  • Cardio Pulmonary Resuscitation –First Aid Red Cross Canada
  • ICH/GCP CERTIFIED - CITI

Therapeutic Area of Experience

  • Oncology: Melanoma, Leukemia, Prostrate Cancer, Throat Cancer, Breast Cancer and CAR-T
  • Psychiatry: Bipolar Disorder, Multiple Personality Disorder and Major Depressive Disorder
  • Neurology: Multiple Sclerosis, Migraine and Parkinson Disease
  • Infectious Disease: HPV
  • Cardiovascular Disease: Myocardial Infraction
  • Respiratory Disease: Asthma

Timeline

Clinical Research Associate II

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06.2017 - Current

Clinical Research Associate I

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05.2014 - 06.2017

Clinical Research Coordinator

Sunnybrook Health Sciences Centre
01.2011 - 05.2014

Bachelor of Science - Marketing (Minor in Biology)

Osun State Polytechnic

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Oluwatobi Bamgbola