AKINWOLE FELIX ALEWI
New Jersey,NJ
Summary
Research Director offering more than 8 years' experience and success in coordinating, conducting and managing hundreds of clinical trial studies from initial sponsor negotiations through to initiation and closeout. Proven leader and skilled in recruiting, training and certifying high performing research and clinical staff. Well versed in good clinical practices (GCP), International Conference on Harmonization (ICH) and institutional review board (IRB) standards. Excited to bring talent, expertise and a results-driven attitude to a growing clinical research organization.
Overview
11
11
years of professional experience
42
42
years of post-secondary education
1
1
Certificate
Work History
Awareness Campaign Assistant
Thaniel Lewis Oil Nigeria Limited
Lagos, Nigeria
08.2010 - 03.2011
- Assisted in media awareness in western part of Nigeria
- Assisted in the day-to-day operations for the duration of the event
- Demonstrated accuracy and thoroughness; monitored own work to ensure quality
- Helped and participated in promoting volunteering through publicity strategies and campaigns.
- Drove data-influenced decisions for campaigns and businesses.
- Safeguarded campaign set up for successful measurement by developing learning plans and allowing for measurability.
- Liaised between account holders and representatives to resolve issues and maintain satisfaction of over [Number] customers.
Assistant Quality Control Officer
Sozo Networks
06.2011 - 08.2012
- Coordinated, and assisted in screening volunteers for the teaching program for youths in the rural areas
- Organized regular outreach drive towards training and mentoring low income teenagers
- Mentored and organized events to attract new volunteers.
- Approved incoming materials by confirming specifications and taking measurement tests.
- Multitasked to handle changing priorities and prioritized workflow to meet critical deadlines.
- Stayed abreast of internal policy, standards, onboarding process and system changes.
- Created and maintained several databases to track statistical data.
- Served as point of contact for individuals seeking [Type] warranty information and worked to resolve customer conflicts and product issues.
- Planned and implemented performance improvement and quality assurance programs.
Clinical Trial Administrator
Drugfield Pharmaceuticals Ltd
11.2012 - 10.2014
- Provided administrative support to clinical trial sites and clinical research associates
- Assisted in the running of clinical trials, writing trial protocols, collection of trial data and writing reports documenting trial outcomes
- Prepared essential clinical trial documents, attended study meetings and arranged investigator meetings, generated filing indexes and maintained currents lists of correspondence
- Tracked and filed clinical trial documents that dealt with suspected unexpected serious adverse reaction (SUSAR) notifications.
- Translated data collection needs into clinic-side standards and tools, collaborating with resources beyond intramural setting.
- Documented patient responses to therapy and adjusted plans of care per protocol specifications, standards of practice and other guidelines.
- Applied sound judgment and clinical expertise in situations lacking established guidelines to inform treatment protocols.
- Managed protocols relating to human subjects research and collection and processing of human samples procured under auspices of NIH IRB-approved clinical research protocols.
- Wrote expert documents relevant to research, clinical care and related subjects.
- Collaborated with team members to comprehend operational demands and manage resource allocation.
Biomedical Scientist (Research Assistant)
Lagos State University Teaching Hospital
Lagos, Nigeria
12.2014 - 06.2016
- Investigating blood samples, tissues, urine for chemical constituents using contemporary computer-aided and computerized testing methods
- Examining cultures grown from samples, identification of blood groups and interpreting results for and liaising with other medical staff in the hospital
- Monitoring the effects of treatment and prescriptions in collaboration with other medical staff
- Sustaining accurate records and writing reports on diagnosis and observations from treatments and prescriptions under close supervision of senior colleagues
- Liaising with General Resources Management personnel about renovations when necessary and provision of necessary infrastructure to create a conducive ambience to patients and work area for the staff, also relates with corporate human resources on personnel questions and issues.
Research Officer
National Agency For Food And Drug Administration And Control
Isolo, Lagos
07.2016 - 11.2017
- Agency for Food and Drug Administration Control NAFDAC (Breast Cancer Awareness Program), Helped plan and promote the event; ensured everything was organized, from recruiting and motivating teams and sponsors to planning day-of-event ceremonies
- Wrote contents for blog posts, magazines and marketing copy to promote the organization’s activities
- Educated the public about prevention and detection to reduce risk of the disease
- Updated the organization website and social media pages with new content on Breast Cancer.
- Built institution's research portfolio in accordance with long-term strategic plan.
- Established strategic goals for broad-scale research through acquisition of appropriate funding and program support.
- Planned and initiated research study protocols, monitored regulatory and subject binders and organized, implemented and administered data collection and analysis systems.
- Directed multiphase clinical research trials from startup to closeout by overseeing training and certifying staff, recruiting patients for trials and managing sponsor relationships.
- Coordinated with advanced practitioners and physicians during pre-study visits, staff orientation, study startup to close out, drug accountability, patient screening, enrollment and follow up, study reimbursement and data collection, sustaining HIPAA requirements at all times.
Clinical Reseach Associate
LabCorp
Union, NJ, NJ
08.2018 - 04.2022
- Collaborated with multidisciplinary team to evaluate patient data and determine patient care plans.
- Monitored patients, evaluated results and recommended further courses of treatment to quickly improve patient outcomes.
- Evaluated nursing practices and processes and made changes.
- Used [Software] to track patient status, treatments and outcomes while maintaining complete data confidentiality in compliance with HIPAA regulations.
Clinical Research Associate
DeTect
Guilford, CT
11.2020 - 11.2021
- Collaborated with clinical study site and sponsor to troubleshoot and provide solutions to study-related issues.
- Coordinated and scheduled protocol-related visits and required testing to demonstrate vigilance in patient safety, protocol compliance and data quality.
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
- Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
- Leveraged [Type] knowledge, expertise and problem-solving techniques to resolve investigative site issues.
- Set up and disbanded trial study centers to manage clinical study activities for [Number] sites.
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
- Processed specimens for clinical trials, sample storage and assay to provide registry of samples for test development, validation and analysis.
- Maintained site monitoring schedules to facilitate effective communication with members of clinical team.
- Adhered to procedures, practices and regulatory requirements to maintain health, safety and environmental compliance.
- Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
Education
Bachelor of Science - Microbiology
University of Ilorin
Master of Science - Public Health
Southern New Hampshire University
Manchester, NH 10.2021 - 04.2023
Associate of Science - Clinical Research
Climnical Rtresearch Fastrack
Arizona City, AZ 04.2020 - 06.2020
Associate of Science - Contact Tracing
Johns Hopkins University
Baltimore, MD 08.2020 - 09.2020
Skills
Microsoft Office (Word, Outlook and PowerPoint) Excel Spreadsheet and databasePhotoshop, Windows OS and Mac OS, Biomedical applications like Soft Work, Matlab, and Adobe PhotoshopSoft: Time management Skills, Good Interpersonal, Analytical and Communication Skills, Organizational Skills, Teamwork and detail oriented
Interviewing skills
Research protocols
Fact checking
Campaign development
Certification
[Clinical Research], [Clinical research Fast-rack
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Master of Science - Public Health
Southern New Hampshire University
10.2021 - 04.2023
Clinical Research Associate
DeTect
11.2020 - 11.2021
Associate of Science - Contact Tracing
Johns Hopkins University
08.2020 - 09.2020
[Clinical Research], [Clinical research Fast-rack
06-2020
Associate of Science - Clinical Research
Climnical Rtresearch Fastrack
04.2020 - 06.2020
Clinical Reseach Associate
LabCorp
08.2018 - 04.2022
Research Officer
National Agency For Food And Drug Administration And Control
07.2016 - 11.2017
Biomedical Scientist (Research Assistant)
Lagos State University Teaching Hospital
12.2014 - 06.2016
Clinical Trial Administrator
Drugfield Pharmaceuticals Ltd
11.2012 - 10.2014
Assistant Quality Control Officer
Sozo Networks
06.2011 - 08.2012
Awareness Campaign Assistant
Thaniel Lewis Oil Nigeria Limited
08.2010 - 03.2011
Bachelor of Science - Microbiology
University of Ilorin