Profile

A Professional Clinical Research Associate with diverse experience in coordinate the collection, distribution, and storage of data obtained during clinical trials conducted in medical and pharmaceutical research programs. Having intensity for providing excellent health care to patients with leadership skills required motivating other staff members to strive to deliver services above standard levels of service. Proven communicator with excellent written and verbal speaking and comprehension skills. Thorough, detail-oriented, and able to manage time wisely. Strives to be friendly and upbeat to facilitate a comfortable working environment for all involved.

Skills

3 years of clinical research experience.

Excellent knowledge of ICH and GCP.

Experience performing site qualification, study initiation, site training, interim monitoring and study close-out visits, and completing timely and accurate site visit reports.

Excellent communication and time management skills.

Ability to perform up to 80% of travel.

Experience in phases I-III clinical trials.

Therapeutic Area

Oncology: CAR T Cell Leukemia, Solid Tumor, Breast Cancer and Melanoma

Neurology: Huntington Disease, Parkinson Disease, Multiple Sclerosis and Schizophrenia

Infectious Disease: HIV and Hepatitis B

Respiratory: COPD and Asthma

Ophthalmology: Age-related macular degeneration

Work Experience

PPD (Chicago, IL) Jan 2020 - Present

Clinical Research Associate II

Conducts a thorough comparison (monitor) of case report forms against medical records on complex trials at multiple sites.

Routinely reviews site compliance data and worked to identify compliance risks and issues.

Monitors and manages study sites, ensuring site's completion of regulatory activities and integrity of clinical data in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs).

Ensures that trials stay on track with clinical objectives and comply with federal regulations, analyze data, creates comprehensive reports, makes presentations and monitors individual cases.

Ensures compliance of the trial conduct with the protocol and the applicable guidelines and regulations.

Participates in the development and preparation of study documents such as Protocol, Case Report Forms, Informed Consent, and Subject Questionnaire.

Independently performs site qualification, study initiation, site training, interim monitoring and study close-out visits, and completes timely and accurate site visit reports.

Maintains regular contact and communication with sites (investigators and other personnel) during the course of studies to ensure compliance with the protocol and to identify any issues.

PPD (Chicago, IL) Mar 2018 - Jan 2020

Clinical Research Associate I

Conducted all visit types on an ongoing and as needed basis.

Identified protocol concerns, notified inspectors of challenges, or aided with problem-solving activities, such as protocol revisions.

Prepared study-related documentation such as process worksheets, procedural manuals, adverse event reports, institutional board approval documents, and progress updates.

Evaluated research questionnaires to be checked and proposed improvements.

Ordered, interpreted, evaluated, and completed QA data tests.

Developed, established, and preserved research conditions that are acceptable for the style of analysis.

Northwestern University (Chicago, IL) Oct 2017 - Mar-2018

Clinical Research Coordinator

Reviewed all the elements of the screening process with the Principal Investigator that being: inclusion/exclusion criteria, completed informed consent, documentation of the event, and the patient willingness to participate in the study.

Performed accurate and complete data entry, case report form completion, and query management.

Performed tasks required by protocol, which may include obtaining patient medical history, systems review, and cognitive assessment on patients.

Participated in monitoring visits, site initiation visits,, implementing trials in accordance with study timelines.

Organized and implemented study procedures for clinical trials and other human subject studies, such as contacting subjects for scheduled clinical visits, and organizing study visits (e.g. for sample collection, survey collection) to fulfill protocol requirements.

Created plans and communicated deadlines to ensure projects were completed on time.

FIIRO-Federal Institute Of Industrial Research: Lagos, Nigeria Jan 2012 - Oct 2017

Microbiologist

Provided technical assistance to all research support staff and schedule all research subjects.

Prepared all documents for manuscripts and maintained an inventory of all ordered equipment and supplies and ensured compliance with all federal policies and mandates.

Managed regular communication with all students and laboratory staff to perform various experiments.

Managed all lab equipment and associate supplies.

Planned and carrying out trials.

Monitored the impact of industrial waste on the local ecosystem.

Evaluated companies GMP, HACCP process, and company SOP to meet microbiology standard.

Assisted students with all biological sample preparation and laboratory procedures for their project.

Nigeria Bottling Company (Cocacola) : Lagos, Nigeria Apr 2008 - Mar 2010

Laboratory Technologist

Responsible for conducting qualitative and quantitative testing of raw materials and finished goods.

Conducted package quality inspection and quality audits and isolate product that does not meet standards.

Maintained the highest possible housekeeping standards to prevent microbial contamination.

Maintained clean work environment and sterilized all lab equipment.

Submitted samples for microbiological testing, maintained test results.

File and maintain retained samples.

Systems Or Technology Experience

EDC: Medidata Rave, DataLabs and IMB

eTMF: VeevaVault

CTMS: Siebel and VeevaVault

Education

Yaba College Of Technology Lagos State, Nigeria 2005

Bachelors of Science In Microbiology

Yaba College Of Technology Lagos State, Nigeria 2001

National Diploma In Science Laboratory Technology

Contacts

Ph: 773-***-****

Address: 106 meadowdale ct apt 107, Carpentersville, Illinois, 60110

Email: adldlk@r.postjobfree.com

Olajumoke Babalola

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