OLANREWAJU ONALA (MD)

HOUSTON, TX.

PHONE-346-***-****.

Email : adxjv3@r.postjobfree.com

With over 15 years of extensive experience in the healthcare industry and clinical practice, I am a highly skilled medical doctor with a strong background in clinical research and data analysis. I have a deep understanding of medical terminologies and regulatory guidelines in clinical research, including the FDA guidance and Good Clinical Practice (GCP). I have a good understanding of basic clinical research data such as adverse events, laboratory data, vitals, and demographic data. My expertise in data analysis includes the ability to analyze, derive datasets, create tables, merge tables, and create graphical representations. I am also experienced in data collection, collation, and cleaning, and have the ability to resolve data-related issues. I understand the importance of data integrity and have the ability to check it to ensure accuracy.

In addition, I have excellent organizational skills, an analytical mindset, and a strong attention to detail. I am able to make informed recommendations based on my analysis and have the ability to implement them effectively. I am confident that my skills and experience make me a valuable asset to any healthcare organization, and I am eager to bring my expertise to your team.

THERAPEUTIC AREAS

Diagnostics

Oncology/Hematology: Breast Neoplasms Phase III, Multiple Myolema

Urology: UTI

Women’s Health:

Infectious Disease: COVID-19 Phase II,

Endocrinology: Diabetes Mellitus

Cardiovascular: Hypertension

EXPERIENCE

OCTOBER 2019-PRESENT

CLINICAL RESEARCH ASSOCIATE II (MEDICAL DEVICE)

Cure Base

Responsible for monitoring the progress of Clinical Trials at Investigative sites, ensuring that they are being conducted, recorded, and reported in accordance with the Protocol, Standard Operating Procedures (SOP’s), IGH-GCP guidelines, and all applicable regulatory requirements.

Ensure the rights, safety and wellbeing of subject are being maintained at investigative sites.

Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents, and maintain the integrity of subject data.

Verify that the investigator has adequate qualifications and resources to participate in a clinical trial.

Review participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.

Assist in the identification of sites and investigators.

Work closely with sites developing subject recruitment strategies.

Timely completion of trip reports, confirmation letters, and follow-up letters for all visits

Assist with completion and retrieval of Regulatory Documents.

File, track and archive TMF documentation and reports

Maintain day-to-day contact with the study sites, including regular telephone contact with the sites as agreed with Sponsor and Project Management.

May 2017 -September 2018

CLINICAL RESEARCH COORDINATOR/ MEDICAL TECHNOLOGIST

BIO REFERENCE LABORATORY

Followed written lab procedures for the correct handling and processing of specimens. Performs lab procedures of moderate and high complexity in accordance with standards set forth in sectional laboratory procedures.

Coordinated with Principal Investigator and department to help ensure that clinical research and related activities are performed in accordance with federal regulations and Institution and sponsoring agency policies and procedures.

Maintained an up to date working knowledge of all technical procedures in the department and operations of all instrumentation. Reviews all pertinent SOPs. Manipulate and operate simple and complex laboratory equipment including computers; may perform maintenance and limited tear down and replacement of parts of laboratory equipment; problem-solve equipment malfunctions.

Arranged secure storage of study documents that will be maintained according to Institution policy or for the contracted length of time, whichever is longer.

Completed study documentation and maintains study files in accordance with sponsor requirements and Institution policies and procedures including, but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms, and investigational material accountability forms.

Worked with the PI to assure that the study follows all terms and conditions, including but not limited to education, IRB approval, conflict of interest disclosure, health and safety protections for participants and staff and any financial terms or conditions.

Performed quality control procedures established for each method and maintains accurate records. Reviews and analyzes quality control data, identifies QC trends or problems, makes judgments, and takes appropriate corrective action. Prior to releasing any test results. (If applicable)

Operated laboratory instruments and performs routine maintenance & procedural calibrations. Diagnoses, troubleshoots, and documents all lab instrument and / or reagent problems. Performs preventative and corrective maintenance/repairs and maintains records of actions. Contact technical services representatives when necessary to resolve problems.

Reviewed accuracy and completeness of results prior to releasing in the Laboratory Information System (if applicable). Recognizes unexpected or unreasonable results and/or testing delays.

Followed protocols for acceptance/rejection of patient results.

Located and transported specimens as per company standards and protocols.

Completed routine and STAT testing within acceptable turn-around time guidelines.

Reviewed Pending Logs, research, and resolves missing specimen issues. If unable to resolve the issue, then the issue must be given to someone on the next shift to continue the process to resolve. If no resolution can be found, the supervisor should be notified.

Participated in the evaluation and development of new procedures, methods, and instruments.

Followed written lab procedures for the correct handling and processing of specimens. Performs lab procedures of moderate and high complexity in accordance with standards set forth in sectional laboratory procedures.

Reviewed accuracy and completeness of results prior to releasing in the Laboratory Information System (if applicable). Recognizes unexpected or unreasonable results and/or testing delays.

Completed routine and STAT testing within acceptable turn-around time guidelines.

JANUARY 2014 -DECEMBER 2016

CHIEF MEDICAL OFFICER,

GENERAL HOSPITAL

Led and developed a team of state and regional medical directors.

Head of Department of Medical Outpatient/Ambulatory unit with Excellent result in reducing patient waiting time and overall treatment output.

Directed overall delivery of patient-focused care and Clinical research, planning, development, and execution.

Aid with healthcare projects through analytic software tools (Tableau).

Formulated procedure for extraction, transformation, and integration of healthcare data.

Provided leadership and management to the clinical division alongside the management team.

Coordinated with the technical team for research and evaluation of healthcare and operational problems.

Coordinated the critical review and revision of the existing systems for update and enhancement.

Coordinated the clinical research procedures and ensured data integrity.

Helped with quantitative data analysis with healthcare biometric and survey data.

Led key opinion leader’s interactions for multiple research projects.

Led the execution of the scientific and medical research plans for multiple therapeutics and disease areas, drugs, medical devices through efficient data analysis.

Provided medical insights and review for clinical research, synopsis, and design.

Provided medical lead on clinical research projects, including protocol development, data analysis,

Ensured research registries are conducted according to all applicable guidelines, regulations, and protocols.

JANUARY 2012 -DECEMBER 2013

DEPUTY DIRECTOR (MEDICAL)

BADAGRY GENERAL HOSPITAL

Led the execution of scientific and medical affairs plans for multiple therapeutic and disease area drug/devices conducted within the hospital.

Organized advisory boards, steering committee, and key opinion leader inputs on how to develop and implement improved screening, diagnosis, and treatment methods.

Provided medical insights and review for clinical research synopsis and design.

Managed team of Medical Doctors and Nurses.

Led key opinion leaders (KOL) interactions for multiple research projects and patient management.

Prepared overall medical affairs plan, strategy, and budget.

Participated site Sub-I for National Research on the effectiveness of Magnesium Sulphate (Mg2SO4) in the management of Eclamptic/Pre-Eclamptic patients in Nigeria.

February 2007 -DECEMBER 2011

ASSISTANT MEDICAL DIRECTOR

GENERAL HOSPITAL

Led Medical Affairs and investigator sponsored research projects.

Provided medical lead on clinical research projects including protocol development, data analysis.

Developed and implemented policies and procedures for development of medical and technical information for hospital, state, and government use.

Led clinical research projects including protocol development, data analysis, publication, improved hospital guidance for Tuberculosis treatment and management unit of the Hospital.

Provided daily clinical consultations for over 30 patients.

Led drug and device studies for screening, diagnosis and treatment of Diabetes and Hypertension.

Provided site clinical lead as a Sub-I for Clinical Research projects, including protocol development, data analysis on National Research on Perinatal morbidity and mortality in Nigeria, published in international journal of Obstetrics and Gynecology, July 2011.

JANUARY 2003 -DECEMBER 2006

SENIOR MEDICAL OFFICER

GENERAL HOSPITAL

Provided clinical consultations for over 30 patients thrice weekly.

Trained and supervised new recruited medical officers in providing high quality patient care.

Engaged in and supervised regular clinical ward rounds.

Supervised the Establishment of the Tuberculosis Treatment and management unit of the Hospital.

Steered the collation and evaluation of clinical data on the incidence and impact of some common diseases within the community.

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EDUCATION

MAY 1999

BACHELOR OF MEDICINE AND SURGERY

UNIVERSITY OF IBADAN, IBADAN, NIGERIA

SKILLS

MS Outlook, MS Word, MS Excel, MS PowerPoint,

EDC: iMedidata, IBM Clinical, Data labs, Rave Bio-Clinical Express

CTMS: Clin

Driving License: Full, Clean

REFRENCES

Available Upon Request.

Contact this candidate