Research Associate Clinical
Resume:
Tayo Ogun
Over ** years’ experience as a Clinical Research associate and Site manager
in Phases 1 to 4 of Clinical trials with a thorough educational knowledge and practical experience of Clinical research methods Site visits, data management, including regulatory requirements, guidelines and CRO oversight
********@*****.***
2405 Scarlet Oak Lane, Baltimore,
21229
WORK HISTORY
December 2018
Senior Clinical Research associate (Remote)
Pristine Clinical Research, Duluth, GA
•Clinical Site selection, Initiation, monitoring and closeout.
• Assisted element team to ensure project
requirements are met and clinical trials are conducted successfully.
• Ensures the team and sites keep to the standards of Good Clinical Practice (GCP) and the relevant
department’s Standard Operating Procedures (SOPs)
• Generated Budgets for proposed sites based on Fair Market Value (FMV).
• Communicate with Study investigators, Study site staff and CRO staff via phone, fax, email and/letters regarding ongoing activities in studies.
• Retrieval of Regulatory documents from sites prior to initiation and during study continuation.
• Investigator site Regulatory Binder Review and TMF updates
• Developed and maintained ongoing relationships
with institutions (CRO and Study Sites).
• Developed Site regulatory binders and their
corresponding hard copy and electronic TMFs.
• Ensure the accuracy of regulatory documents in
both hard copy and eTMF.
• Reviewed participating sites’ CTAs with the Legal Department before final approval
• Processed Purchase order numbers (PO number) and Invoices (using excel) for tasks completed by
participating sites.
• Daily monitoring of Study sites and eCRFs for new trends and adherence to Protocol amendments.
• Making suggestions to Project Manager on how to
efficiently manage the study.
• Established trial sites through site staff training, Investigational Product (IP) and trial materials
THERAPEUTIC AREAS
Infectious Disease: Influenza,
Meningitis, Covid
Dermatology: Psoriasis and
Rosacea
Urology: Overactive bladder
Cardiology: Hyperlipidemia,
Mixed Dyslipidemia,
Device: Lap Band, Bladder
Stimulator, Implantable cardiac
pacemaker.
In vitro diagnostics: Siemens
Advia Centaur Immunoassay
System.
CNS: Parkinson’s Syndrome,
Multiple Sclerosis, Epilepsy
Orphan Disease: Pediatric Severe
Combined Immunodeficiency
Neurology: Aneurism,
Amyotrophic lateral sclerosis,
Optic nerve research: Optic
Neuritis
EDUCATION
December 2019
Certificate in Analytics:
Optimizing big data
University of Delaware,
Wilmington
January 2006
Clinical Research Training
Medical Resources
Management, Miami Fl
management.
June 2017 to December 2018
TMF Analyst (In-House)
Glaxo Smith Cline, Collegeville, PA
• Consistently ensured that TMF is inspection ready and in alignment with the study agreed strategy
and applicable milestones.
• Ensured the clinical trial documentation is
consistent with trial master file agreements and
applicable Standard Operating Procedures
(SOPs), ICH GCP (Good Clinical Practice).
• Provision of project management expertise to
Study Accountable Person (SAP) and their study
team members globally as needed (e. g.
instream quality check of trial master file data,
drafting and preparation of documents etc.) to
support their study deliverable targets, to agreed quality and data integrity standards.
• Served as point of contact for the study teams
for TMF matters and liaise with TMF Subject Matter Experts (SMEs) and process owners to help their
understanding of requirements and associated
solutions to ensure trial master files are always
inspection ready.
• Assisted in the development and delivery of
training materials at the study level and provide
subject matter expertise.
• Understood all technical aspects of Pharma TMF
system and associated tools. Liaise with third
party providers, performing as part of the cross-
functional team.
• Ensured that the documents are filed to meet
the required timelines and the Analyst would
ensure there is no deviation from the plan and
follow up appropriately.
• Acted as the expert and point of contact for any audit and inspections and assist with the
development of correction action plans, if
related to any findings.
• Monitored and identified trends for a study under support.
• Drove the TMF completeness metrics and track
performance.
January 2016 to June 2017
Senior Clinical Research Associate (in-house)
Thomas Jefferson University Hospital, Philadelphia, PA Master of Science Zoology
University Of Ibadan, Nigeria,
Ibadan
Bachelor of Science Fisheries and
Wildlife Management
University Of Agriculture
Abeokuta, Nigeria
• Developed data management planning
documents such as Database Design
Specifications (DDS)
• Exported Specifications; and case report forms
(CRFS) and instructions.
• Created procedures, user manuals, training
materials, and other data management
documents for the assigned clinical trials.
• Communicated with database programmer,
sponsors and internal staff regarding study
specifics.
• Prepared reports and correspondence for data
management section as needed.
• Oversaw data management personnel and
coordinate review teams within the data
management section to validate databases by
performing User Acceptance Testing (UAT) and
Edit Check Testing (ECT)
• Created data management timelines and
monitor adherence to established timelines, as
well as, recommend corrective action as
necessary
June 2015 to December 2015
Senior Clinical Research Associate (in-house)
Advance Clinical, Philadelphia, PA
• Worked closely with management teams to
plan, develop, coordinate and execute
technical strategies aligned to client's vision,
mission and purpose.
• Ensured that proper data management
governance and best practice processes are
applied to study data.
• Reviewed and approved user access requests
for the CRM and Telephony systems and
manage the process of provisioning access.
• Managed the user roles in CRM including the
permissions granted to roles as well as the
linking of users to system roles.
• Input into and support the development,
implementation and ongoing administration of
a Data Management Policy alongside
Information Security resources.
• Planed, managed, and requested resource as
required for assigned studies.
• Maintained a consistent, manageable workflow
for Data Management project team by
monitoring enrollment information and
communicating with project team to actively
influence data collection.
April 2012 to April 2015
Senior Clinical Research Associate (Remote)
Icon Clinical Services, North Wales, PA
• Conducted site qualification, initiation,
monitoring and close-out visits.
• Home Based senior regional CRA.
• Monitored and Managed 14 clinical research
sites.
• Maintained ongoing clinical research site
correspondence and site files.
• Reviewed and tracked IP supply and patients'
recruitment and visits through the IVRS.
• Reviewed patient charts and clinical research
data. •
• Completed visit reports and maintained study-
related databases.
• Performed source document verification,
reviewed electronic Case Report Forms (CRFs)
and performed query resolution in a timely
manner.
• Oversaw drug accountability and safety at
investigative sites.
• Ensured Serious Adverse Event (SAE) reporting
according to project specifications.
• Responded to requests from investigative sites
in a timely fashion.
• Mentored junior level CRAs and serve as a
resource for new employees.
• Served as a resource for and interacted with
other functional areas to resolve site issues and
facilitate project timelines.
November 2010 to February 2011
Senior Clinical Research Associate (Remote)
PRA International, Raleigh NC
• Assured that all relevant members of the
internal team and sponsor are informed of
progress and status of assigned projects with
recommendations for any anticipated
outstanding issues.
• Monitored and Managed 15 clinical research
sites.
• Conducted investigator recruitment and
essential document collection activities as
assigned, including review, and tracking
activities.
• Assisted with initial study submission as
necessary.
• Conducted site qualification, initiation,
monitoring and close-out visits.
• Reviewed site-specific informed consent forms
against required elements and finalize with
internal team, sponsor and site.
• Forwarded documents to be filed in the project
master file and/or at the sponsor as outlined in
the Investigator Documentation Plan
• Assisted in identifying and implementing best
practices and continuous improvement plans
within the department/company
• Maintained working knowledge of the
Company's standards/SOPs and FDA/ICH
guidelines and regulations.
• Performed ongoing review of TMF to assure
quality of the documentation files and
compliance with company SOPs, GCP and ICH
Guidelines.
• Accountable to provide and develop
regulatory documentation to support study start
up activities, including all site supplies.
• Acted as primary liaison for assigned study sites to convey project information, answer
questions and in accordance with the CTM
escalation pathway to the Lead CRA. Resolve
site related issues.
• Attained thorough understanding of study and
Site management tasks and responsibilities
necessary to implement compliance with
protocol/regulatory requirements and
company SOPs.
• Collaborated with the Lead CRA to
obtain/share trial specifics issues across all study sites concentrating on areas related to quality,
site performance and metrics
• Responsible for communicating issues in
accordance with the CTM escalation pathway
to the Lead CRA and CRAs as appropriate
April 2010 to November 2010
Senior Clinical Research Associate (Remote)
Pharm-Olam International, Huston, TX (Remote)
• Home based CRA working on a Phase II Urology
and Phase II/III GI – Lap banding study in
patients with BMI equal to or greater than 40.
• Monitored and Managed 14 clinical research
sites. • Conducted interim monitoring and
Close out visits.
• • Resolved data queries and confirmed site
generated data using Inform eDC
• Scheduled site visits for junior CRAs to meet up with sponsor scheduled timeline for database
lock.
• Assisted Project Manager with vendor requests.
• Implemented and monitored clinical trials to
ensure sponsor and investigator obligations are
being met and are compliant with applicable
local regulatory requirements and ICH
guidelines.
• Visited sites to assess the qualification of
potential investigative sites, initiated studies
• Instructed site personnel on the proper conduct
of studies, to review data and ensure accuracy
of data collected and to terminate studies.
• Provided regular clinical status information to
team members and project management
team.
• Performed billable work in accordance with
Pharm Olam policies, procedures, and
Standard Operating Procedures (SOPs).
• Worked closely with other team members to
ensure timely resolution of project and/or
clinical issues and obtained direction from more
senior clinical operations staff.
• Conducted site qualification, initiation,
monitoring and close-out visits.
• Communicated common site trends to Lead
CRA and other project team members.
• Performed source document verification,
retrieved Case Report Forms (CRFs).
• Performed query resolution in a timely manner
and tracked drug accountability and safety at
investigative sites.
• Ensured Serious Adverse Event (SAE) reporting
according to project specification
April 2008 to April 2010
Senior Clinical Research Associate (Remote)
AAI Pharma/ZEECRO, Wilmington/NC
• Home based CRA responsible for the
management and monitoring of sites
participating in clinical trials in the Northeastern region.
• Monitored and Managed 14 clinical research
sites.
• Ensured study documents (e.g., Case Report
Forms, Source Documents and Serious Adverse
Events reports) are reviewed and tracked to
ensure completeness and accuracy in line with
protocol stipulated standards.
• Reviewed and clarified data changes at
individual sites; issued and resolved queries
using the eDC system.
• Assisted site personnel and lead team members
in reviewing subject recruitment strategies to
ensure timely randomization and study progress
• Utilized the Inform eDC system for source
verification and submission of sites' data.
• Assisted Clinical Project Manager in preparing
necessary tools to maintain consistency in study
data across all sites and monitors.
• Tracked and managed drug and clinical
supplies distribution.
• Assisted in the development of and
compliance with study timelines.
• Ensured site visits are conducted in compliance
with study protocol, FDA regulations and ICH
requirements relative to clinical research.
• Assisted with vendors' management and
associated data.
• Conducted Qualifying site visits, Site initiation visits, Interim monitoring visits and Site Close out visits.
July 2006 to April 2008
Clinical Research Associate (In-house)
Pharmanet, Blue Bell, PA
• Improve knowledge of diseases and conditions
under study by attending bimonthly training
sessions.
• Maintained site documentation with 98%
accuracy, performing reviews of Case Report
Forms (CRF), source document verification and
query resolutions.
• Conducted site monitoring visits based on site
specific enrollment figures to verify constant
adherence to Good Clinical Practice (GCP)
and International Conference on
Harmonization (ICH) guidelines.
• Applied protocol stipulated standards and my
employer's SOPs to correctly evaluate quality
and integrity of study site practices, promptly
escalating issues to Study Manager for
resolution.
• Supervised full monitoring cycle of 18 sites
across 3 protocols from initiation to close-out.
• Optimized patient care by promptly reporting
critical test results to Medical Monitor to
minimize treatment delays.
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