Gabriel Orakwe
East Orange,New Jersey
Summary
As a seasoned Clinical Research Associate with extensive experience, I bring exceptional analytical and communication skills to the table, coupled with an in-depth understanding of FDA regulatory requirements. My strengths lie in my ability to maintain superior organizational and record retention capabilities, as well as effectively managing time. Moreover, I possess strong expertise in designing clinical research projects and project plans, making me a valuable asset to any research team.
Overview
13
13
years of professional experience
Work History
Clinical Research Associate
Atlantic Health System
Freehold, NJ
01.2020 - Current
- Adhered to good clinical practices, operating procedures and regulatory requirements.
- Supports the development of clinical trial protocols; participates in the development of the overall clinical plan, drafts protocols, collaborates on statistical analysis plans, and coordinates the protocol review and approval process, to include submissions to regulatory agencies.
- Participates in the identification of potential investigators and clinical sites, both nationally and internationally; conducts pre-study site visits, collects and reviews data, and prepares evaluative reports; participates in the final selection of investigators and study sites.
- Assists with the development and implementation of study-specific monitoring and reporting procedures, methods, guidelines, and tools; participates in the establishment of baseline parameters and edit check specifications, and in the development of subject tracking systems.
- Conducts clinical trial site initiation visits; advises and trains site personnel on sponsor and regulatory requirements for study conduct; participates and/or conducts site meetings and multicenter investigator meetings and prepares reports.
- Conducts site monitoring visits and follow-up to identify significant problems and issues and to ensure that all clinical aspects of studies are being carried out in accordance with state and federal regulations, guidelines and policies.
- Reviews on-site files and records, case report forms, and source documents for completeness, accuracy, consistency, and compliance; identifies deficiencies and discrepancies, and provides remedial training and/or initiates corrective action as required.
- Ensures appropriate transmission of clinical case data to the data management centers; reviews case report queries and problems, and clarifies and/or obtains changes to data as appropriate.
- Interfaced with clinical investigators and site staff to foster ethical research consistent with research plans
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues
Clinical Research Coordinator
Frontage Lab
Secaucus, NJ
03.2018 - 12.2019
- Facilitated the recruitment and enrollment of participants for Oncology Clinical Trials by developing effective outreach strategies and collaborating with healthcare providers and patient advocacy groups.
Accurately recorded and managed clinical research data in accordance with the study protocol and regulatory requirements using electronic data systems such as EDC or CTMS.
Coordinated patient visits and procedures related to research, ensuring timely and efficient scheduling and communication with the clinical team and study participants.
Provided expert guidance and support to study participants by addressing their inquiries and concerns regarding the research procedures and potential risks or benefits.
Maintained strict compliance with local and federal laws and regulations, as well as Good Clinical Practice (GCP) guidelines and sponsor-specific SOPs, by performing regular site monitoring and quality checks.
Oversaw the recruitment, training, and performance of study staff members, ensuring their competence and adherence to the study protocol and ethical standards. - Maintained compliance with protocols covering patient care and clinical trial operations
- Screened patient records, databases, and physician referrals to identify prospective candidates for research studies
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols
- Collected data and followed research protocols, operations manuals, and case report form requirements
CNA
Promedica Senior Care
East Orange, NJ
04.2013 - 01.2018
- Assisted patients with shaving, bathing and oral hygiene to promote healthy habits and overall wellness.
- Facilitated activities of daily living, personal hygiene management, feeding and ambulation.
- Conducted routine checks on patient vitals, blood pressure, blood sugar and heart rate.
- Exhibited compassionate care and communication regarding issues surrounding death and dying.
- Responded to patient alarms and needs-assessment requests to identify course of treatment.
- Rendered hands-on nursing care under direct RN supervision, adhering to medical center policies and procedures.
- Maintained accurate, timely flow of information by completing thorough patient records and updating healthcare team on patient status.
- Consulted with nurses to develop patient care plans and evaluate treatment options.
- Offered immediate assistance in emergency and routine paging situations to evaluate needs and deliver care
- Delivered individualized patient care by recording vital signs, documenting observations, administering treatments, and evaluating patient needs
- Checked patient vitals such as temperature, blood pressure, and blood sugar levels
Optical Receptionist
Community Health Centers
Newark, NJ
09.2010 - 03.2013
- Created and maintained accurate and confidential patient files according to regulatory mandates.
- Maintained office supplies inventory by checking stock and ordering new supplies as needed.
- Managed front office customer service, appointment management, billing and administration tasks to streamline workflow.
- Adhered to HIPAA requirements to safeguard patient confidentiality.
- Called patients to schedule appointments, consistently double-checking information and availability.
- Helped patients complete paperwork and explained processes and procedures.
- Answered 50 average daily phone calls to schedule appointments and address patient inquiries.
- Completed claims forms for different types of appointments and worked on resolutions for denials or other insurance issues.
- Coordinated office schedules for new patients, diagnostic assessments and procedures.
Education
Bachelor of Science - Biological And Physical Sciences
University Of Benin
Nigeria07.2005
Skills
- Interactive management
- Patient safety
- Patient recruitment strategies
- Research and Development
- Site management
- Clinical research monitoring experience
- Microsoft- Word, Excel, powerpoint, one note
- CTMS - SIEBEL, Bioclinica
- EDC - Medrio, Medidata rave, Oracle
- ETMF - Veeva Vault
- Oncology, Cardiology, Rare Disease and vaccine expertise
Timeline
Clinical Research Associate
Atlantic Health System
01.2020 - Current
Clinical Research Coordinator
Frontage Lab
03.2018 - 12.2019
CNA
Promedica Senior Care
04.2013 - 01.2018
Optical Receptionist
Community Health Centers
09.2010 - 03.2013
Bachelor of Science - Biological And Physical Sciences
University Of Benin
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