SOLOMON ADELOWO
Chicago,IL
Summary
Experienced, motivated, result-driven Clinical Research Professional with over 12 years of clinical research experience and 7 years of Clinical Research Management.
Overview
13
13
years of professional experience
Work History
Manager, Clinical Research Validation Specialist & Rush's PRS Administrator for Clinicaltrials.gov Site
RUSH UNIVERSITY MEDICAL CENTER- OFFICE OF RESEARCH AFFAIRS
11.2017 - Current
- Facilitates accurate, timely maintenance, and harmonization of clinical trial data/information via various databases, systems like CTMS-OnCore, Data Management System (RedCap), and Institution's Research Portal system
- Manages and/or leads small teams within assigned functions including validation and triage responsibilities
- Effective application of GCP methodology during synchronization/review of clinical trials contract and budgeting language, coverage analysis, IRB process to include a review of IRB application as well as approved and amended submissions, and elements of Informed Consents to each database/system to validate information in all systems
- Trained and supervised newly hired Sync Specialists and managed sync work queues and day-to-day processes
- Manages team that reviews coverage analyses, budgets & contracts, including regulatory documents with a particular focus on compliance with government, sponsor, legal, and institutional policies, and procedures for the most complex clinical research studies
- Decision maker for colleagues in the Office of Research Affairs and the Clinical Departments to resolve inconsistencies with contractual language, the coverage analysis, the budget, or study regulatory documents
- Delegates the final approval on harmonization of research-related documents and ensures documents are ready for signature by the institution's authorized signatory
- Implements solutions to Identified business problems related to the harmonization process and ensures solutions to such challenges are in line with all regulations and Rush policy
- Also, implemented strategies for the research validation team to ensure accountability and consistency
- Delegates the training of faculty and staff to ensure compliance with institutional, sponsor, and federal regulations related to harmonization for research
- Contributes to the facilitation of the development of educational workshops on related policies and procedures
- Implements strategy to focus on harmonization review turnaround times with a focus on streamlining the review process
- Participate in various interdepartmental meetings across the institution and provide updates and guidance when necessary
- As the institutional PRS administrator, I oversee and manage about 400 registered studies on clinicaltrials.gov for the institution, while maintaining over 95% compliance rate.
Clinical Research Regulatory Coordinator
ELMHURST-EDWARD HEALTH- CANCER CENTER
07.2014 - 09.2017
- Oversaw a little over 260 clinical research regulatory compliance aspects, including document preparation, submission, and management for a specified portfolio of clinical trials.
- Coordinated and prepared on-time submission of regulatory documents to the Institutional Review Board (IRB), NCI CIRB, Cooperative groups, industrial clinical research sponsors, and Contract Research Organizations (CROs) as necessary to meet all internal and external regulatory compliance standards.
- Performed initial review, preparation, and submission of research protocols, informed consent documents, Investigator brochures, patient education materials, study case review forms (CRFs), IRB submissions during study start-up, amendments, annual continuing reviews, study closures, serious adverse events, and protocol deviation reporting.
- Prepared and participated in numerous internal (IRB) and external (CROs, sponsors, vendors) site visits and audits.
- Oversaw maintenance and compliance of about 20 research staff credentialing, study-related, and CITI training, including annual recertification, etc., ensuring compliance per GCP and FDA.
- Prepared and submitted more than 100 informed consent documents and study budgets to ensure that they followed institutional, local, and federal policies and regulations per GCP.
- Participated in about 100 oncology tumor board meetings to identify potential research patients for enrollment.
Clinical Research Compliance and Regulatory Coordinator (Contract Job)
NORTHWESTERN MEMORIAL HOSPITAL
05.2013 - 03.2014
- Provided guidance and consultations to research staff, medical students medical residents, and newly employed research staff on research study submission, COI, HIPAA and IRB, Medicaid/Medicare, grants submissions, and leased research equipment to ensure compliance with regulations and guidelines.
- Reviewed and facilitated several research grant submissions such as grant application letter of intent, sub-award agreement endorsement request, and proposed budget for accuracy and final endorsement
- Facilitated well-organized Standard Operative Procedure for the Office of Research.
- Conducted about 150 patient chart audits electronically via the electronic medical record (EMR) system and EDW (electronic Data warehouse) to make sure all necessary research results, information, and necessary forms were properly documented and complete.
- Reviewed all IRB applications to ensure compliance with hospital policies and regulations, and applicable federal/state research laws
- Presented high-risk studies to Sr. VP of Medical Affairs/Human Subject Protections Officer for determination.
- Revised and endorsed IRB applications for IRB approval and performed comprehensive clinical trial coverage analysis on each IRB application to determine what items/services were billable to Medicare (or other payers) before the study began enrollment.
- Utilized extensive clinical expertise and knowledge of all medical specialties/ancillary departments in performing coverage analyses
- Conducted comprehensive review of consent forms, Clinical Trial Agreements /contracts, study budgets, and protocol schema to ensure consistency with billing template.
- Provided billing template to the researchers to ascertain items and services associated with the project were billed to the appropriate parties.
- Guided researchers in alerting subjects to their financial liability
- Facilitated short-term placement/lease agreements for execution for all research study CAPITAL equipment between the Hospital and the sponsor/vendor, to make sure that all equipment follows the state, federal, city of Chicago, and Biomedical regulations and standards.
- Arranged several teleconference meetings with sponsors/pharmaceutical companies and the hospital's research staff to discuss issues at hand and attended several IRB monthly panel meetings.
Research Assistant/Coordinator (Non-Paid Volunteer/Internship)
UNIVERSITY OF CHICAGO MEDICAL CENTER
01.2012 - 12.2012
- Developed questionnaires and conducted telephone interviews with research participants.
- Screened over 100 research participants to determine their eligibility to be a part of the research study (inclusive criteria).
- Assisted with analyzation and interpretation of qualitative and quantitative statistical data to formulate results. for at least 10 research studies.
- Helped to develop and review research studies for IRB submission.
Education
Doctor of Health Science (DHSc), Research Concentration -
Walden University
Minneapolis, MN01.2026
Master of Science – Clinical/ Health Informatics -
Walden University
Minneapolis, MN12.2015
Completed Clinical Research Coordinator courses - Clinical Research
Northwestern University-NUCATS
Northwestern University07.2015
Bachelor of Science - Bioscience -
DePaul University
Chicago, IL03.2013
School of Surgical Technology -
Naval School of Health Science
Portsmouth, VA06.2005
Skills
- Strong leadership
- Outstanding written and verbal communication
- Robust Project, Timelines, People, and Resources Management
- Familiarity with various clinical research databases and software
- Strong presentation
- Management of clinical trial operations for Phase I-IV clinical research studies
- Research budget proficiency
- New staff hiring and performance evaluations
- Clinical trial oversights
- Extensive knowledge of FDA regulations, GCP & ICH guidelines
- Research Compliance and Audits
- Expert in clinicaltrialsgov registration and management
- Extensive organization
- Proficient in Microsoft Office
- Multitasker with attention to every small detail
Accomplishments
- Successfully developed and implemented more than 10 departmental and Institutional SOPs, job aides, and research educational materials.
- Played a vital role in the development and implementation of Research Operations; Research Portfolio; and/or ORA Management data, metrics, and/or KPIs to support greater transparency and accountability across the institution.
- Initiated or co-facilitated research-related institutional DEIJ initiatives for example: Lyft, UberHealth, and Kaizen Health, were identified as transportation providers for research subjects to facilitate participation in clinical research; Implemented Advarra Subject Compensation System to more quickly and accurately pay subjects removing barriers for bank accounts and other systemic banking issues that disproportionally impact lower-income individuals.
- Reviewed more than 1000 research legal, financial, and regulatory documents to ensure that they were compliant with the institutional, local, state, and federal laws/policies.
- Successfully led the facilitation of the first Clinicaltrials.gov (CT.gov) initiatives and improvement workshop with five other institutions, which led to a significant improvement in the institutional compliance rate from 53% to 99% within 3-4 months.
- Developed and institutionalized a CT.gov- auto-generated question set with real-time responses for registration determination. Since the implementation, we've been able to improve our registration requirement compliance score by 90%.
- Recognized for my clinical trials management and compliance skills and experience, I took on additional job titles (dual role) that saved the institution more than $80,000 annually (FTE salary).
- Supervised and managed a team of 8-10 staff with a 100 % retention rate through a work-life balance module.
- Played a key role in the successful development of a corrective action plan (CAPA) and addressed all the audit findings which resulted in the end of a long-time suspension and, also, facilitated the institution's first-ever industrial sponsor studies with a high enrollment and retention rate and outstanding data, patient and regulatory reporting.
- Act as a consultant/advisor to the leadership on areas of uncertainty by providing them with comprehensive and calculated risk analysis to help facilitate their decision-making.
- Reviewed more than 100 research medical journals and publications to ensure that they're in alignment with the information from clinicaltrials.gov.
- Successfully facilitated and implemented a work improvement process which helped streamline the institutional review process and improved organization study activation turnaround for contract execution and patient recruitment by 56%.
Awards
- MAGI (Model Agreements & Guidelines International) - Active member
- PRIM&R (Public Responsibility In Medicine And Research) - Active Member (In progress)
- SOCRA (The Society of Clinical Research Associates)- Active member (In progress)
- ACRP (Association of Clinical Research Professionals)-Active Member
- NIH-IPPCR Certificate (Introduction to the Principles and Practice of Clinical Research) - June 2018
- Red Cross Certified Basic Life Support Instructor (Inactive)
- AHIMA-Active member
- DePaul University Dean's List
- Honorable Discharge from the United States Military with decorated medals
Timeline
Manager, Clinical Research Validation Specialist & Rush's PRS Administrator for Clinicaltrials.gov Site
RUSH UNIVERSITY MEDICAL CENTER- OFFICE OF RESEARCH AFFAIRS
11.2017 - Current
Clinical Research Regulatory Coordinator
ELMHURST-EDWARD HEALTH- CANCER CENTER
07.2014 - 09.2017
Clinical Research Compliance and Regulatory Coordinator (Contract Job)
NORTHWESTERN MEMORIAL HOSPITAL
05.2013 - 03.2014
Research Assistant/Coordinator (Non-Paid Volunteer/Internship)
UNIVERSITY OF CHICAGO MEDICAL CENTER
01.2012 - 12.2012
Doctor of Health Science (DHSc), Research Concentration -
Walden University
Master of Science – Clinical/ Health Informatics -
Walden University
Completed Clinical Research Coordinator courses - Clinical Research
Northwestern University-NUCATS
Bachelor of Science - Bioscience -
DePaul University
School of Surgical Technology -
Naval School of Health Science
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