Data Entry Clinical Research

Olorunyomi Ifeoluwapo

Chicago IL 312-***-**** adrnn1@r.postjobfree.com

Objective

A driven and result oriented clinical trial manager with over 8 years of clinical research experience. Supports critical initiatives in engineering and sciences that advance how science serves the world. ICH and GCP certified with experience in phases I-IV clinical trials.

Therapeutic Areas of Experience

Rare Disease: Fabry’s Disease

Oncology: Solid Tumor, Non-Small Cell Lung Cancer, CAR T Cell Lymphoma, Prostrate Cancer and Glioblastoma

Neurology: Major Depression and Bipolar Disorder

Infectious Disease: COVID-19

In Vitro Diagnostics: Capillary Prototypes

Knowledge & Skills

Solid understanding of the clinical study process.

Proficient working knowledge of the regulations (Food and Drug Administration (FDA), Good Clinical Practice (GCP), International Committee on Harmonization (ICH), ISO, etc).

Organizational awareness to operate in cross-functional teams and provides leadership to other clinical staff members.

Effective communication and time management skills.

Commits to work in a safe environment that is quality- and customer-focused.

Excellent ability to take and maintain initiative.

Possesses strong interpersonal skills with the ability to interact with peers, medical professionals, consultants, and Regulatory Agencies as required.

Excellent ability to plan, problem solve with the use of critical thinking skills.

Phases I-IV clinical trials.

Ability to travel as needed.

Work Experience

Clinical Trial Manager/Clinical Study Manager, 06/2018 to Current

Syneos Health – Chicago, IL

Designs, implements and manages clinical studies.

Manages clinical studies and ensures they are carried out in accordance with the Protocols, Good Clinical Practices (GCP's), Standard Operating Procedures (SOP's) and other regulatory requirements.

Collaborates in the development, approval, and distribution of study-related documents including study protocols, informed consent documents, case report forms, study plans, study manuals, training materials, and other study tools to investigational sites and review committees.

Monitors on-going compliance to study protocols and site adherence to global regulatory guidelines.

Prepares and participates in presentation of protocols and other study requirements at study initiations at investigational sites when needed.

Manages the distribution, collection and tracking of regulatory documentation to ensure compliance at both the sites and Sponsor Central File, and for audit readiness.

Tracks and reports progress of studies including patient enrollment/screening, patient accountability, device accountability, etc.

Works with Data Management as needed to ensure proper data is provided for their input analysis and output of reports.

Prepares and provides timely reports to management.

Assists in the development and management of study budget.

Maintains registrations on Clinical trial.gov.

Reviews Monitoring Trip Reports provided by Field Monitors.

Selects and qualifies clinical trial investigational sites, including managing aspects related to physician relationships, and manage IRB/EC approvals (initial and ongoing).

Participates in the development and implementation of internal policies & procedures to optimize management of clinical trials; contribute to process improvement.

Oversees and participates, as needed, in site close-out visits, report reviews, and follow-up to resolve final site issues.

Works with Regulatory Affairs as needed to provide accurate and timely reports, such as annual reports or safety reports to the FDA and other regulatory bodies.

Senior Clinical Research Associate, 03/2017 to 06/2018

Syneos Health (formley INC Research) – Chicago, IL

Assessed the suitability of clinical sites to conduct specific studies.

Initiated selected clinical study sites by providing training related to the protocol and management of the study.

Performed routine monitoring of clinical study sites to ensure subject safety and protocol compliance.

Responsible for the verification of data entered on the CRFs is consistent with clinical notes and other source documents.

Collect completed CRFs and queries from clinical sites.

Wrote monitoring visit reports and ensured the accountability of all test articles.

Closed-out of clinical sites upon completion of the study.

Assisted with study file audits and site audit preparation.

Developed and maintained routine contact with clinical study investigators and staff.

Assisted with protocol, case report form and source document template development.

Ensured compliance with appropriate regulatory (GCP, FDA, ICH, HBP, etc.) and internal guidelines.

Assisted with final report preparation.

Assisted with internal SOP/guideline development.

Coordinated supplies forecasting and distribution and communicated across departments and conducted project team meetings concerning status of the study and specific sites.

Assisted in the occasional mentoring and training of Clinical Research Associates on monitoring procedures.

Clinical Research Associate I/II, 04/2014 to 03/2017

AstraZeneca – Chicago, IL

Managed assigned investigational sites.

Performed monitoring of assigned investigational sites, including: site qualification visits, initiation visits, routine monitoring visits, and close-out visits.

Supported Project Management in the conduct of site feasibility assessments (may include participating in or managing the site selection process, analyzing patient recruitment and retention rates).

Organized and performed site initiation visits and site training activities.

Functioned as the primary point of contact with the site.

Coordinated, organized, and managed clinical study coordinator teleconferences on a routine basis.

Monitored site recruitment and enrollment activities. When applicable, coordinated recruitment plans with applicable sites.

Performed review and reconciliation of regulatory documents at the investigational site against the trial master file.

Verified biological sample collection, storage, and shipping procedures at the site as required per study protocol.

Verified laboratory and all applicable study data was reviewed by the investigator, properly captured in the case report form, and if necessary, is reconciled with the CRF.

Ensured study supplies are maintained in an ongoing manner.

Prepared and organized local institutional review board (IRB)/ethics committee (EC) submissions in collaboration with the site(s) and Clinical Trials Associates, as necessary.

Clinical Research Data Coordinator, 05/2013 to 04/2014

Northwestern University, Feinberg School Of Medicine – Chicago, IL

Reviewed, synthesized and abstracted information from medical records (clinic notes, pathology reports, radiology reports, patient questionnaires, etc.) to extract industry, cooperative, and investigator-initiated trial data as specified by research protocol into sponsor Electronic Data Capture (EDC) to support all research studies.

Completed study visits and/or element completion in CTMS to correspond to EDC data entry.

Completed all data entry (EDC and CTMS) within 72 hours of study visit.

Performed quality assurance checks to ensure the accuracy of data entered.

Worked with providers/coordinators to identify and address data discrepancies and queries.

Prepared documents and coordinated the study team, including principal investigators and pharmacists, for internal and/or external compliance monitor review/audit.

Performed as a liaison between sponsored trial monitors and provider/coordinators.

Worked with providers to identify data points to answer queries and perform query function to export data requests.

Provided weekly/monthly enrollment reports and other reports as needed.

Certifications

Good Clinical Practice (2022)

Basic Life Support and AED- American Heart Association (2022)

Registered Nurse (2022)

Languages

English

Native or Bilingual

Yoruba

Native or Bilingual

Technology

CTMS: VeevaVault and Impact

EDC: Medidata Rave, Inform, DataLabs and Trialmaster

eTMF: VeevaVault

IWRS: Suvoda and Oracle

Microsoft: Office, Excel and Powerpoint

Education

Bachelor of Science: Nursing

Chamberlain College of Nursing - Addison, Illinois

Bachelor of Science: Medicine and Surgery

LAUTECH - Nigeria

Contact this candidate