Naga Igie
Newark,NJ
Summary
Dedicated Clinical Research Specialist offering resilience, resourcefulness, and a goal-oriented approach in today's dynamic healthcare landscape. Data-driven and efficient communicator committed to driving innovation, aspiring to make a lasting impact on future generations.
Overview
5
5
years of professional experience
1
1
Certificate
Work History
CRA/Site Manager
Janssen Pharmaceuticals
Raritan, NJ
11.2019 - Current
- Provide site management and monitoring support for sponsored clinical trials
- Perform CRF reviews, query generation, recommend or carryout training/resolution against data review guidelines utilizing Jenssen’s data management systems
- Performs site management activities, including but not limited to site qualification visits (QV), site initiation visits (SIV) and interim monitoring visits (MV) at assigned clinical sites; generated visit/contact report in a timely manner
- Retrieve and process regulatory documents for investigational studies in compliance with monitoring guidelines
- Performs IP reconciliation and accountability
- Participates in various sponsor/project team communication and training sessions, prepare for and attend Investigator meetings
- Responsible for the evaluation of clinical data to ensure investigator and site compliance with the study drug protocol, overall clinical objectives, FDA regulations, ICH/GCP Guidelines
- Develops patient recruitment strategies in conjunction with the clinical site to meet enrollment timelines
- Ensure compliance with the approved standard operating procedures (SOPs), protocol/amendment(s), GCP, and the applicable regulatory requirement(s).
Clinical Research Training/Internship
Mainseed Research Group
Alpharetta, GA
01.2019 - 11.2019
- Core Competencies Covered: ICH GCP E6 R(2) FDA Regulations 21CFR 11, 50, 54,56 and the Common Rule 45CFR46 Data Management Informed Consent Process Clinical Trial Operations from feasibility through close-out
- GDP following ALCOA-C principles Identification and reporting of AEs and SAEs Quality Assurance, Monitoring and Query Resolution Comprehension and Execution of Clinical Trial Protocols Maintaining regulatory binder, housing essential documents including but not limited to 1572, DOA, Training Logs and other Investigator Site File (ISF) documents
CLINICAL RECRUITER
Mainseed Research Group
Alpharetta, GA
12.2018 - 11.2019
- Quality Assurance, Monitoring and Query Resolution Efficiently recruited top talents for leading pharmaceutical, biotechnology, medical device and CRO companies across the Northeast, Southeast, Northwest and Midwest
- Performed full-cycle recruiting and successfully placed Scientific, Regulatory Affairs and Drug Safety professionals
- Developed best strategies to source candidates in a timely and efficient way
- Utilized Job Boards (Monster, LinkedIn, ZipRecruiter, Indeed, CareerBuilder, etc.), internal and personal databases (Oracle PeopleSoft and Microsoft Excel) and internal and external referrals to source candidates
- 1 of 3 members of a scientific team, focused on managing all scientific requisitions and developed internal strategies in order to place the best candidates in the most efficient way in our client’s sites
- Gathered market knowledge and stayed abreast of industry updates
- Contributed in brainstorming activities and data analysis for process improvement.
Education
Bachelor of Science - Biochemistry
Ambrose Ali University
MBA - Masters in Business Administration
Cambridge College
Boston, MASkills
- Therapeutic Experience with Phases II & III
- Progressive On-site Co-monitoring experience
- Strong experience with GCP, FDA regulations and ICH guidelines
- Strong leadership and interpersonal skills
- Strong problem-solving skills
- Excellent self-management, organizational skills and detailed oriented
- Computer Skills: MS Office, InForm , DataLab, Medidata rave, Omnicomm TrialMaster, Bioclinica Express, Pioneer (CTMS) Oracle-Seibel (CTMS) , IMPACT (CTMS)
- Proficient in EHR (Electronic Health Record) cloud based software, eg Revolution and Infinity
- Proficiency in fabrication engineering processes Eg lathe machine engine block re-sleeving, welding, cutting, grinding etc
- Beginner knowledge in French
Certification
- GCP
- ICH
Timeline
CRA/Site Manager
Janssen Pharmaceuticals
11.2019 - Current
Clinical Research Training/Internship
Mainseed Research Group
01.2019 - 11.2019
CLINICAL RECRUITER
Mainseed Research Group
12.2018 - 11.2019
Bachelor of Science - Biochemistry
Ambrose Ali University
MBA - Masters in Business Administration
Cambridge College
Highlights
- Proficient in MS Office Suite
- Excellent verbal and written communication skills
- Social media expertise (Facebook, LinkedIn, Twitter)
- Operating systems: Windows, Linux, and Mac OS
- Service-oriented and customer-focused
- Bilingual: English and Edo
Clinical Research Training
Mainseed Research Group, Alpharetta, GA, 01/2019-11/2019, ICH GCP E6 R(2), FDA Regulations 21CFR 11, 50, 54,56 and the Common Rule 45CFR46, Data Management, Informed Consent Process, Clinical Trial Operations from feasibility through close-out., GDP following ALCOA-C principles, Identification and reporting of AEs and SAEs, Quality Assurance, Monitoring and Query Resolution, Comprehension and Execution of Clinical Trial Protocols, Maintaining regulatory binder, housing essential documents including but not limited to 1572, DOA, Training Logs and other Investigator Site File (ISF) documents
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Therapeutic Area
- Respiratory – Asthma (Phase 2), COPD (Phase 2), COVID-19 (Phase 2 Infectious Disease)
- Neurology – Ataxia Telangiectasia (Phase 3 Rare Genetic disease for adult & Pediatric population - orphan Drug)
- Oncology – Non Small Cell Lung Cancer (NSCLC) (Phase 3)
Quote
there are no geniuses, there's only those that are willing to try and those that are not willing to.
Naga
OTHER TECHNICAL AND RELEVANT SKILLS
– Proficient in EHR (Electronic Health Record) cloud based software, e.g. Revolution and Infinity.
– Proficiency in fabrication engineering processes. E.g. lathe machine engine block re-sleeving, welding, cutting, grinding etc.
– Beginner knowledge in French.
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