ADEOLA ODUSANYA
Perth Amboy,New Jersey
Summary
Dedicated Senior Clinical Research Associate successful at evaluating sites, initiating trials, and managing closeouts. Experienced with Phase I-III trials and successful at adapting to new processes. Bringing excellent organizational, planning, and interpersonal skills gained during a 10+ year career.
Overview
22
22
years of professional experience
Work History
Sr. Clinical Research Associate
ICON Plc
03.2020 - Current
- Performs study initiation activities, reviewing with the site personnel the protocol, regulatory issues, and study procedures, and provides training on completion of the eCRF; monitoring activities, and study close-out activities
- Review the quality and integrity of the clinical data through the review of electronic CRF data perform on-site source verification and work with sites to resolve data queries
- Provide protocol and related study training to assigned sites and serve as the main liaison to participating clinical trial sites with a focus on data entry, query resolution, clinical sample shipment, recruitment, and overall site activity
- Ensures data cleaning process is performed and performs source data verification of study data entered into EDC
- Collaborate regularly with study lead and clinical study sites to ensure timely delivery of study milestones
- Contribute to the preparation and amendments of study-related documents (informed consent forms, clinical trial agreements, budgets)
- When applicable, coordinate recruitment plans with applicable sites
- Perform review and reconciliation of regulatory documents at the investigational site against the trial master file
- Verify laboratory and all applicable study data is reviewed by the investigator, properly captured in the case report form, and if necessary, is reconciled with the CRF
- Ensure study supplies are maintained in an ongoing manner
- Assist with organizing IRB/EC submissions with follow-through to ensure successful outcomes
- Work with the site to process and collect data related to resolving any issue
- Working efficiently and effectively with the site to resolve open queries through effective time management.
- Facilitated successful cross-functional collaborations for the completion of key projects, fostering strong working relationships among team member
- Contributed to protocol development, ensuring a well-designed study that met research objectives while adhering to ethical standards and regulations.
- Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
- Managed activities of vendors and investigators to ensure compliance with the study protocol and overall clinical objectives
- Provided input to Clinical Study Reports and Investigator Brochures, including data cleaning, listing review and report writing
- Provide oversight to vendors, specifically leading oversight activities related to clinical monitoring from site qualification to site closure visits and assure the integrity clinical data for accuracy, accountability and documentation through review of case report forms, source documents and medical records
- Collaborate with clinical , regulatory , and quality team members to ensure department/study activities comply with FDA regulations, guidelines and principles of ICH GCP and company SOP
Sr. Clinical Research Associate
Novartis Pharmaceuticals
08.2016 - 03.2020
- Performed site selection, initiation, monitoring, and close-out visits in accordance with the contracted scope of work and good clinical practice
- Provided monitoring visits and site management for a variety of protocols, sites, and therapeutic areas
- Administered protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
- Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations
- Participated in the investigator recruitment process
- Performed site evaluation visits of potential investigators
- Evaluated the capability of the site to successfully manage and conduct the clinical study
- Assessed & and managed test article/study supply including supply, accountability, and destruction/return status
- Reviewed & and followed up on on-site payment status and conduct on-site study-specific training (if applicable)
- Performed site facilities assessments and follow-up on CRF data entry, query status, and SAEs
- Built relationships with investigators and site staff
- Facilitated and supported sites with access to relevant study systems and ensure sites are compliant with project-specific training requirements
- Addressed and resolved issues at sites, including, questions, potential deficiencies in documentation, communication, and the need for additional training
- Escalated quality issues to Clinical Project Manager (CPM), Clinical Research Specialist (CRS), and/or line manager
- Managed the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution
- Created and maintained appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters, and other required study documentation
- Acted as a mentor for new clinical staff, provide assistance to the Clinical Project Manager and/or CRS with the design of study tools, documents, and processes
- Managed employee training for new clinical staff over a period of two weeks offering continuous guidance and mentorship on best practices while providing constructive feedback.
Clinical Research Associate II
Inventive Health
10.2015 - 07.2016
- Maintained appropriate professional relationships utilizing an assertive, business-like manner which fostered study compliance
- Managed and reviewed routing and moderately complex site data including case report form (CRF) completion and submission, data query resolution, and overall data integrity according to established practices with minimal to no guidance
- Provided training for site personnel on appropriate source documentation, CRF completion, data procedures and timelines, and query resolution
- Provided timely notification to appropriate study contacts of site status and trial-related needs
- Performed monitoring visits: ensured adherence to protocol, accurate data collection via comprehensive source document verification, and investigational product accountability.
Clinical Research Associate
Parexel International
11.2012 - 10.2015
- Ensured protocol adherence, conducting regular site visits and providing training to study staff as needed.
- Managed multiple projects simultaneously while maintaining a high level of attention to detail and meeting deadlines.
- Served as inhouse support by conducting outbound. inbound calls from study sites to:
- Review recruitment plan and enrollment updates
- Address /resolve issues pending from the previous visit
- Address protocol questions, check on site staff assignments, review site payment status, follow up on data entry, query status and SAE's
- Developed strong relationships with investigators and site personnel to ensure ongoing compliance with study requirements.
- Assessed safety reporting requirements for each study, ensuring proper documentation and notification procedures were followed consistently.
Regional Site Manager
Research Pharmaceutical Services
01.2011 - 08.2012
- Achieved departmental goals by developing and executing strategic plans and performance metrics.
- Enhanced customer satisfaction by resolving disputes promptly, maintaining open lines of communication, and ensuring high-quality service delivery.
- Followed drug storage procedures to comply with protocols and SOP requirements.
- Interfaced with clinical investigators and site staff to foster ethical research consistent with research plans.
- Liaised with clinical investigator to identify, assess and resolve site performance, quality and compliance issues.
- Submitted routine Monitoring reports and follow-up letters to facilitate internal and external communication.
Clinical Trial Assistant
I3 Pharma
10.2010 - 12.2011
- Performed eTMF Review and QC activities using the sponsor system and tools
- Supported clinical trial execution by coordinating with cross-functional teams and ensuring regulatory compliance.
- Maintained internal metrics based on established guidelines
- Responsible for executing assigned tasks to ensure project deliverables are met
- Performed QC on all studies including site, protocol and country level documents( using a randomized sampling of at least 5% of total documents.
- Provided an inventory listing, documenting missing documents with discrepancies
Stability Chemist
Givaudan Fragrances
02.2002 - 06.2010
- Enhanced product quality by developing and optimizing chemical processes and procedures.
- Maintained laboratory documenation with details of test procedures , raw data and final results in accordance with regulatory guidelines
- Performed calibration , standardization and routine maintenance of instrumentation
- Performed other QC activities such as method transfer within Quality
- Responsible for performing testing of Stability Product, following SOP and written procedures QCM for clear, concurrent documentation performed during testing to calculate and report results on applicable specifications.
- Followed GMP regulations
Education
Bachelor of Arts - Chemistry
Hunter College of The City University of New York, New York, NY
01.2002
Skills
- Monitoring Visits
- Reviewing Data Standards
- Trip Reports
- Site Management
- Action Planning/Time Management
- Trial Oversight
- Deep understanding of ICH GCP Compliance
- Research Experience
- Veeva Vault, Rad (TMF)
- Medidata Rave, Siebel, IMPACT, Veeva Vault (CTMS)
- Oracle Inform, Medidata, (EDC)
- MS Suites (Word, Excel, PowerPoint, Project, Publisher, Access & Outlook)
Therapeutic Experience
- Medical Device: Cardiovascular: Atrial Fibrillation Hypertension, Diabetes (Type 2), Acute Coronary Syndrome, Knee Replacement, Phase II-III
- Ophthalmology AMD and wet/dry degeneration experience. Biomarkers of retinal diseases, Phase III
- Central Nervous System/Neurology: Parkinson's Disease, Rheumatoid Arthritis, Multiple Sclerosis, Schizophrenia, Depression, Phase II, Alzheimer Disease Phase II
- Oncology: Multiple Myeloma, Solid Tumor, T-cell lymphoma Small Cell Lung Cancer, Phase I, Renal Clear Cancer Phase III
- Urology: Urinary disease, Phase II, Idiopathic Overactive Bladder, Benign Prostatic Hyperplasia
- Dermatology: Psoriasis, Phase III, Severe Acne
Work Availability
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Sr. Clinical Research Associate
ICON Plc
03.2020 - Current
Sr. Clinical Research Associate
Novartis Pharmaceuticals
08.2016 - 03.2020
Clinical Research Associate II
Inventive Health
10.2015 - 07.2016
Clinical Research Associate
Parexel International
11.2012 - 10.2015
Regional Site Manager
Research Pharmaceutical Services
01.2011 - 08.2012
Clinical Trial Assistant
I3 Pharma
10.2010 - 12.2011
Stability Chemist
Givaudan Fragrances
02.2002 - 06.2010
Bachelor of Arts - Chemistry
Hunter College of The City University of New York, New York, NY