Clinical Research Data Entry
Resume:
KEHINDE O AWOBAJO
Somerset, NJ *8873
732-***-**** **************@*****.***
SUMMARY
Clinical Research Associate with expertise in conducting clinical research
trials by recruiting subjects for various clinical trials, preparing site
for site selection, monitoring trials and closing out visits. Working
knowledge of US FDA, EU and ICH regulations, CFRs, GCPs, auditing
procedures, drug development and research process. Detail oriented person
with the ability of identifying problems, analyzing it and providing
solutions. Result driven, analytical skills, positive attitude and a team
player.
TECHNICAL SKILLS AND LANGUAGE
Electronic Data Capture: Inform, ADEPT and Rave
IVRS: Clinphone and Ramos
Submission Management: eCTDXPress, ISIToolbox, Coredossier, ISIPublisher,
Core report and Insight publisher.
Document Management: Documentum (WebEDI)
Other: RSGT, ARISG, Novstyle, Microsoft Office: (Word, PowerPoint,
Access, Excel, Works, Outlook,), Lotus Notes and
Visio.
EXPERIENCE
Novartis Pharmaceutical Corporation, East Hanover, NJ 2006-Present
Clinical Research Associate
Conducting site monitoring visits to identify significant issues and
ensuring that all clinical aspects of the studies are being carried out in
accordance with GCP/ICH guidelines.
. Participating in the identification of potential investigators and
clinical sites.
. Conducting pre-study site visits, collecting and reviewing data, and
preparing evaluative reports.
. Conducting clinical site initiation visits.
. Advising and training site personnel on sponsor and regulatory
requirements for study conduct and preparing reports.
. Reviewing on-site files and records, case report forms, and source
documents for completeness, accuracy, consistency, and compliance.
. Identifying deficiencies and discrepancies, providing remedial training
and initiating corrective action as required.
. Providing site support for remote data capture.
. Monitoring data capture remotely and reviewing it for completeness and
consistency.
. Generating and resolving queries between monitoring visits.
. Attending investigator meetings.
Glaxo Smith Kline, Philadelphia, PA 2004 - 2006
Clinical Research Associate
Conduct site-monitoring visits to perform 100% source document
verification, protocol compliance, regulatory compliance, and drug
accountability.
. Co-monitoring and monitoring responsibilities on-site under the
assigned lead CRA's direction
. Performed Pre-study visits, Initiation visits, Routine Monitoring
Visits and Close-out visits.
. Verified documented informed consent for each subject and assured the
protection of the rights, safety and well being of human study`
subjects.
. Source Document Verification: Analyzed and evaluated clinical data, to
ensure investigator and site compliance.
KEHINDE O AWOBAJO
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. Source Document Verification: Analyzed and evaluated clinical data, to
ensure investigator and site compliance
with the study drug protocol, overall clinical objectives, and ICH Good
Clinical Practice (GCP) guidelines
. Conducted accountability of investigational product during study visits
and ensured the proper storage and handling of investigational product.
. Review of regulatory documents and essential clinical research
documents required for study initiation.
. Assisted team members and clinical team leader (CTL) with designated
administrative tasks in support of clinical trial execution and
management
. Maintained and managed data entry into subject enrollment tracking
systems
. Prepared, managed and distributed clinical documentation and reports as
needed
. Assisted with coordination and distribution of clinical trial supplies
(excluding investigational products)
. Managed case report forms (CRF) and clinical data flow
. Assisted with project meeting organization
. On-site assistance- accompanied Clinical Team Leader and CRA on site
visits and assisted with filing as directed
Aventis (Aerotek), Bridgewater, NJ 2004-2004
Regulatory Specialist
Re-organized and re-formatted all the electronic submissions in the DRA
archive department thereby shortened a 3 month contract to 2 months.
. Indexed submissions in an electronic format for the archiving group.
. Managed electronic files on finalized submissions.
. Coordinated with scientific editor to develop and update policies and
procedures for design and formatting of documents and artwork.
Pfizer Inc., (Atrium Staffing Resources), Bridgewater, NJ 2003 - 2004
Drug Safety Associate
Worked with Physicians, PharmD and Nurses on reviewing adverse even
reaction cases received from global tracking system by checking its
accuracy and completeness. Entered cases into RSGT and ARISG safety
docbase in a fast manner for physicians and the regulatory team before
cases are locked for completeness and sent to health authorities.
. Received regular recommendation/ovation from safety director(s) because
of consistency in identifying discrepancies and meeting timelines.
. Lead staff member, coordinated activities of fellow staff member and
ensured that work proceeded in an efficient manner.
. Assisted regulatory safety associates and physicians with
troubleshooting cases with discrepancies.
. Reviewed and data entry of adverse event drug safety reports using
ARISG and forwarding cases using tracking database RSGT.
. Responded to adverse event queries by providing solution or reason why
there is discrepancy in the report.
. Trained and provided guidance to fellow drug safety associates.
EDUCATION
Master of Business Administrator (MBA), Regis University, Denver, CO,
anticipated graduation 2011
Bachelor of Arts, Computer Science, Rutgers University, New Brunswick, NJ
Associate Degree (AS), Applied Science, County College of Morris, Randolph,
NJ
KEHINDE O AWOBAJO
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CERTIFICATE
2006 Adobe Certified Expert (ACE)
2004 Clinical Research Associate (CRA) and Clinical research coordinator
training, Rutgers University, Newark, NJ
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