Open To Work
JAMES ADEYEMI
Dallas-Fort Worth Metroplex,STATE_US
Summary
Detailed Oriented Clinical Research Expert with Strong Organizational and Interpersonal skills. Twelve plus years of clinical research experience in Phase II-IV trials. Advanced knowledge in ICH-GCP guidelines for clinical research. Proven track record of bringing poorly performing sites up to standard.
Tech-savvy innovator with hands-on experience in emerging technologies and passion for continuous improvement. Skilled in identifying opportunities for technological enhancements and implementing effective solutions. Adept at leveraging new tools and methods to solve problems and enhance productivity. Excels in adapting to fast-paced environments and driving technological advancements.
Possesses versatile skills in project management, problem-solving, and collaboration. Brings fresh perspective and strong commitment to quality and success. Recognized for adaptability and proactive approach in delivering effective solutions.
Organized and dependable candidate successful at managing multiple priorities with a positive attitude. Willingness to take on added responsibilities to meet team goals.
Detail-oriented individual with exceptional communication and project management skills. Proven ability to handle multiple tasks effectively and efficiently in fast-paced environments. Recognized for taking proactive approach to identifying and addressing issues, with focus on optimizing processes and supporting team objectives.
Demonstrates strong analytical, communication, and teamwork skills, with proven ability to quickly adapt to new environments. Eager to contribute to team success and further develop professional skills. Brings positive attitude and commitment to continuous learning and growth.
Proactive and goal-oriented professional with excellent time management and problem-solving skills. Known for reliability and adaptability, with swift capacity to learn and apply new skills. Committed to leveraging these qualities to drive team success and contribute to organizational growth.
Pursuing full-time role that presents professional challenges and leverages interpersonal skills, effective time management, and problem-solving expertise.
Equipped with strong problem-solving abilities, willingness to learn, and excellent communication skills. Poised to contribute to team success and achieve positive results. Ready to tackle new challenges and advance organizational objectives with dedication and enthusiasm.
Overview
13
13
years of professional experience
Work History
Independent Clinical Research Consultant
Self Employed
06.2024 - Current
- Full monitoring responsibilities.
- Clinical Research Related Experience
Process and Standards Lead
Pfizer via Parexel
11.2023 - 04.2024
- Represent Global Sites and Study Operations (GSSO) on Standard Operating Procedures (SOPs) and process review, determines impact and provides recommendations or suggestions as needed.
- Seek out, identify, and drive process improvements with a focus on standardization; the ability to work cross functionally is critical to build consistency in standard processes.
- Drive implementation of new and revised processes.
- Provide frequent communications or clarifications for the entire GSSO organization.
- Interface with Clinical Development Quality (CDQ) and the Business Process Owner Network (BPON) as point of contact for GSSO.
- Champion the implementation and use of harmonized consistent processes and excellence across GSSO deliverables related to cost effective, timely, and high-quality clinical trial data according to agreed global goals.
- Maintain the curricula for roles within GSSO (i.e., Study Manager, Site Oversight Leads, etc.) and for monitoring partners.
- Maintain the Educators and Accelerators across the roles within GSSO (i.e., Study Manager, Site Oversight Leads, etc.)
- Develop and facilitate training and education for the groups and roles within GSSO.
- Provide onboarding and ongoing training support for the groups and roles within GSSO.
- May be involved in mentoring of others and building/sustaining a mentoring and buddying process and plan for all GSSO.
- Coordinate education sessions, as needed.
- Facilitate the sharing of functional area expertise and best practices within GSSO.
- Serve as the initial point of contact and technical expert for questions about study management, monitoring and oversight related processes, systems, and responsibilities; may be required to primarily focus in one of these areas.
Site Relationship Partner/Manager
Pfizer via Parexel
07.2021 - 09.2023
- Usher investigator sites through site activation and study activities start up to close out.
- Review and approve site's informed consent documents by making modifications and corrections as necessary per approved study country informed consent template.
- Generate and complete Global Review and Approval Form for all approved informed consent documents.
- Maintain regular communications with investigator sites to gather status updates, informal and formal performance metrics, and study-level feedback.
- Enlisted as the main point of contact for all site- and study-level questions, consulting with and escalating to appropriate teams to respond and resolve questions. Effectively follow up and close issue status with investigators to ensure awareness of resolution.
- Inform and educate investigator sites of Client pipeline opportunities that may be a good fit.
- Lead effective site recruitment planning and implementation of plans at the country- and site-level, consistent with global plan and local targets.
- Responsible for proactively providing local intelligence.
- Provide country/regional level input to country outreach surveys including protocol feasibility, country Standard of Care (SOC), and medical practices.
- Provide country/regional level input to country strategy/planning and site recommendation through intimate understanding of country, sites, processes and practices, and associated site performance metrics.
- Review and manage site practices that differ from Client practices and consult with study teams and study management.
- Understand targeted site criteria as well as services delivered to target sites.
- Track that all such services are provided consistently and in a timely manner.
- Recommend potential targeted sites and conduct follow up with those sites as required.
Senior Clinical Research Associate
IQVIA Biotech
04.2021 - 07.2021
- Full Monitoring Responsibilities.
- Perform follow-up to ensure resolution of significant problems or issues noted at the site.
- Conduct site closeout visit tasks including test article reconciliation, review of completeness of study files, and retrieval of all outstanding documents.
- Prepare timely, comprehensive, and detailed reports documenting visit findings.
- Ensure regulatory inspection readiness at assigned clinical sites.
Senior Clinical Research Associate
Worldwide Clinical Trial
06.2016 - 03.2021
- Full Monitoring Responsibilities.
- Serve as a mentor for newly hired CRAs.
- Conduct Accompany Site Visits/Co-Monitoring visits with newly hired CRAs.
- Conduct SWOT and Rescue visits for under/poorly performing sites.
Clinical Research Associate & Sr CRA
Quintiles (IQVIA)
09.2013 - 06.2016
- Identifying potential qualified investigators and clinical sites and conducting pre-study site visits.
- Conduct clinical site initiation visits, including training of site personnel on Sponsor and regulatory requirements for study conduct.
- Conduct monitoring visits including on-site review of source documents and case report forms for completeness, accuracy, consistency, and protocol compliance.
- Perform investigational product accountability to ensure adequate storage, dispensing, and subject compliance.
- Track essential documents during the length of the study at assigned sites.
- Perform follow-up to ensure resolution of significant problems or issues noted at the site.
- Conduct site closeout visit tasks including test article reconciliation, review of completeness of study files, and retrieval of all outstanding documents.
- Prepare timely, comprehensive, and detailed reports documenting visit findings.
- Ensure regulatory inspection readiness at assigned clinical sites.
Education
Expert Certification - Good Clinical Practice for Clinical Trials
Barnett International
Registered Respiratory Therapist - Respiratory Therapy
National Board For Respiratory Care
Respiratory Care Practitioner - Respiratory Therapy
National Board For Respiratory Care
Bachelor of Science - Respiratory Therapy
Texas State University
San Marcos, TXSkills
- Respiratory Disease - Asthma, COPD
- Central Nervous System - Multiple Sclerosis, Nicotine Dependence
- Cardiovascular - Hypertension, Myocardial Infarction, acute congestive heart failure, hypertension with chronic kidney disease
- Infectious Disease - HIV, Ear Infection, Hep C, Norovirus, Covid-19
- Ophthalmology – Glaucoma, Bacterial Conjunctivitis
- Endocrinology - Diabetes Type II, Diabetes Type I
- Gastrointestinal Disease – Ulcerative Colitis
- Cardiovascular – Angina, Hypertension, and weight management in obese adolescents
- Oncology – Metastasis Breast Cancer, Prostate Cancer, Colorectal Cancer
- EDC
- Inform
- Medidata/RAVE
- Trial Master i-CRF
- CTMS Siebel
- Prelude Vision
- CTMS
- Impact
- Oracle 40
- CTMS ANSWRS
- Infolink 2 (IL2)
- BIOCLINICA
- OnPoint
- IxRS/IRT
- Almac
- Clinphone
- Worldwide
- Clinical
- Oracle IRT
- IWRS
- HealthSouth Medical Center, Dallas TX, Lead Respiratory Therapist, May 2002 to September 2013
- Fully proficient in MS Office: Outlook, Word, Excel, and PowerPoint
- Friendly, positive attitude
- Teamwork and collaboration
- Customer service
- Problem-solving
- Time management
- Attention to detail
- Flexible and adaptable
- Dependable and responsible
- Verbal communication
- Problem resolution
- Decision-making
- Organization and time management
- Active listening
- Calm under pressure
- Organizational skills
- Computer skills
- Critical thinking
- Excellent communication
- Multitasking Abilities
- Multitasking
Recognition and Awards
Embrace Teamwork Award, May 8, 2020., Above and Beyond Award, December 20, 2019., High Five from President and COO, May 04, 2017., STAR Performance Award, December 20, 2016., Tenacious Performance Award, January 12, 2021., Customer Relationship, Leadership, Quality Focused, Teamwork and Collaboration, Communication, and Innovation, February 9, 2022., Leadership, Quality Focused, Teamwork, Collaboration, Communication. March 21, 2022, Team Player, May 25, 2022., Customer Relationship, Leadership, Quality Focused, Team Player, Communication, and Innovation, June 10, 2022., Customer Relationship, Teamwork and Collaboration, June 20, 2022., Customer Relationship, Teamwork, Leadership and Collaboration, March 2023.
Languages
English
Timeline
Independent Clinical Research Consultant
Self Employed
06.2024 - Current
Process and Standards Lead
Pfizer via Parexel
11.2023 - 04.2024
Site Relationship Partner/Manager
Pfizer via Parexel
07.2021 - 09.2023
Senior Clinical Research Associate
IQVIA Biotech
04.2021 - 07.2021
Senior Clinical Research Associate
Worldwide Clinical Trial
06.2016 - 03.2021
Clinical Research Associate & Sr CRA
Quintiles (IQVIA)
09.2013 - 06.2016
Expert Certification - Good Clinical Practice for Clinical Trials
Barnett International
Registered Respiratory Therapist - Respiratory Therapy
National Board For Respiratory Care
Respiratory Care Practitioner - Respiratory Therapy
National Board For Respiratory Care
Bachelor of Science - Respiratory Therapy
Texas State University