Opeyemi Edemirukaye
3 Crystal Place ,NJ
Summary
Accomplished Clinical Research Professional offering 11 years experience working with large, medium sized Global CROs and Pharmaceutical companies. With over 4 years experience working in CRA lead positions; acquiring vast knowledge in developing planning methods and techniques to meet research objectives. Very knowledgeable in monitoring and managing site operations across multiple phases and diverse therapeutic areas of Clinical trials.
Overview
11
11
years of professional experience
Work History
Senior Clinical Research Associate
Lisata Therapeutics
Bridgewater, NJ
11.2023 - Current
- Acts as primary liaison for assigned study sites to convey project information,
answer questions and resolve site-related issues in accordance with the clinical
monitoring plan - Attains thorough understanding of study management tasks and responsibilities
necessary to implement compliance with protocol/regulatory requirements and
applicable SOPs - Attends Investigator Meetings and study-specific training for assigned trials
- Knowledgeable of assigned protocol(s) and trial specific manuals/plans to ensure
quality and deliverables are met across assigned sites - Completes pre-study qualification visits, site initiation visits, routine monitoring
and close-out visits within established timelines, documents activities in reports
and as applicable in accordance with applicable SOPs and plans - Develops and maintains strong collaborative working relationships with clinical
investigative sites - Assures the trial site adequacy and applicable personnel qualifications on an
ongoing basis - Develops and executes corrective action plans at the site level, proportionate to
the risks identified - Accountable for data integrity, patient safety and regulatory compliance for all
assigned sites - Monitors recruitment and data quality while on site and remotely through systems
and communication with sites - Responsible for ongoing data review and source data verification to study-
specific targets and deadlines - Collaborates with data management to plan and meet data cut and lock
deadlines - Performs on-site drug accountability, reconciliation, and return, when applicable
- Verifies trial product receipt, handling, accounting, and storage meets protocol
requirements - Assists the study team in preparation for audits/inspections and is responsible for
the quality and completeness of site related performance and documentation
Senior Clinical Research Associate
ICON Plc
North Wales, PA
11.2021 - 11.2023
- Conduct overall site management and site visits (Pre-study, Initiation, Monitoring and Close out) in accordance with contracted scope of work and good clinical practice. Ensuring appropriate documentation of site management and monitoring findings are updated by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Maintainance of patient care protocols and clinical trial operations in compliance.
- Mentoring and training of new CRAs, conducting oversight visits and reviewing trip reports.
- Collaborate with sponsors and investigators to carry out efficient and fully compliant research trials.
- Perform Quality Oversight Visits for sites in preparation for Client and FDA audits.
- Participate in regulatory activities and submission by adhering to independent ethics committee and regulatory board.
- Develop logic models, performance measures and data collection programs.
- Participates in Vendor selection process and management
- Collaborate with project teams to contribute research methods for trials.
- Track study-specific trial management tools and systems.
- Communicate research and analytical findings to research team.
- Manage study site with strict adherence to data security measures.
- Perform ongoing management of the Trial Master File (TMF) and/ or investigator site files by ensuring essential documents are uploaded and filed appropriately.
Principal Clinical Research Associate
Pharmaceutical Product Development LLC
Wilmington, NC
07.2020 - 11.2021
- Managed the progress of assigned studies through tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
- Mentoring and training of new CRAs
- Conduct overall site management and site visits (Pre-study, Initiation, Monitoring and Close out) in accordance with contracted scope of work and good clinical practice.
- Performed Quality Oversight Visits for sites in preparation for Client and FDA audits.
- Conduct multiple onsite and remote visits within very strict timelines, performing data review and query resolution activities for Emergency Use Authorization of Study drug.
- Coordinate with the study team to ensure timely initiation and completion of clinical trials.
- Perform ongoing management of the Trial Master File (TMF) and/ or investigator site files by ensuring essential documents are uploaded and filed appropriately.
- Ensure appropriate documentation of site management and monitoring findings are updated by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Identified potential threats to properly manage project risks.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Trial Manager (CTM), Clinical Research Specialist (CRS) and/or line manager.
Senior Clinical Research Associate
SynteractHCR
Carlsbad, CA
05.2019 - 06.2020
- Conduct overall site management and site visits (Pre-study, Initiation, Monitoring and Close out) in accordance with contracted scope of work and good clinical practice.
- Coordinate with the study team to ensure timely initiation and completion of clinical trials.
- Perform ongoing management of the Trial Master File (TMF) and/ or investigator site files by ensuring essential documents are uploaded and filed appropriately.
- Ensure appropriate documentation of site management and monitoring findings are updated by submitting regular visit reports, generating follow-up letters and other required study documentation.
- Manage the progress of assigned studies through tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.
- Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), Clinical Research Specialist (CRS) and/or line manager.
- Mentor and coach new clinical staff members
Senior Clinical Research Associate
Marinus Pharmaceuticals
Radnor, PA
12.2019 - 04.2020
- Performed pre-study, closeout and interim visits to check on study activities.
- Evaluated proof of eligibility and consent for participants.
- Reviewed site regulatory binder to check collection procedures and completeness of paperwork.
- Identified potential threats to properly manage project risks.
- Checked electronic data capturing systems for integrity and compliance.
- Participated in regulatory activities and submission by adhering to independent ethics committee and regulatory board.
- Tracked study-specific trial management tools and systems.
- Managed study site with strict adherence to data security measures.
- Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
Senior Clinical Research Associate III
IQVIA
Raleigh, NC
09.2014 - 05.2019
- Managed site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work while ensuring good clinical practice.
- Administered protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
- Improve site quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate 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.
- Ensure appropriate documentation quality regarding site management, monitoring visit findings and action plans by submitting timely visit reports, generating follow-up letters and other required study documentation.
- Improve relationships through liaising with customers and external vendors
- Coordinate with the Clinical Project Manager and/or CRS with design of study tools, documents and processes.
Clinical Research Associate II
Covance Clinical Research
Madison, WI
04.2013 - 09.2014
- Manage all aspects of site monitoring responsibilities for clinical trials, according to company SOPs, ICH/GCP guidelines, including general on-site monitoring responsibilities and problem solving.
- Manage protocols from different study sponsors, ensuring all sponsor-specific guidelines and adherence to timelines.
- Coordinate with Project Managers, Investigators, site staff, Data Management; monitor data and prepare and submit detailed reports of study conduct.
- Independently performed CRF review, query generation and resolution against established data review guidelines on company or client data management systems
- Assess the implementation of Project Plans related to the Clinical Monitoring responsibilities
- Coordinate with company and sponsor quality assurance teams to assess site issues, overall study conduct and site performance.
- Assist with training of new clinical research associates.
Education
Bachelor of Science - Cell Biology And Genetics
University of Lagos
Lagos, NigeriaSkills
- Sponsor/CRO Collaboration
- Critical Thinking
- Attention to Detail
- Records Management (Paper and Electronic)
- TMF Management
- Vendor Selection/ Management
- Site Audit Preparation (FDA and BIMO)
- Clinical Contract Processing
- Excellent communication skills
- Patient Recruitment Strategies
- Case Report Management
- Supervision & Leadership
- Documentation Requirements
- Site and Study Management
- Monitoring Visits
- Data Quality and Management
- Team Management
Therapeutic Experience
- Infectious Disease: Covid 19 (Adult population Phase II), Covid 19 (Pediatric population Phase II), Covid 19 (IVD) Pediatric Hepatitis B (Phase II, III); HIV (Phases I-IV)
- Oncology: Breast Cancer (Phase III), Bladder Cancer (Phase III), Ovarian Cancer (Phase III), Lymphoma (Phase IB & II), NSC Lung Cancer (Phase III), Cholangiocarcinoma (Phase II).
- Endocrinology: Diabetes – Type II (Phase II, III), Hyperglycemia (IVD)
- Gastroenterology/Hepatic: Gastroparesis (IVD-Phase II), Fatty Liver Disease (Phase II)
- Neurology/Psychiatric (includes CNS): Stroke (Phase II); Alzheimer’s, Schizophrenia (Phase I, II, III), Alcohol Dependence (Phase II)
- Ophthalmology: Diabetic Macular Edema (Phase III), Glaucoma (Phase III), Sjogren's (SHOW-grins) syndrome (Phase I), Macular Degeneration (Phase 1), Dry Eyes (Phase II)
- Pediatric Rare Diseases (CDKL5, Status Epilepticus, Tuberous Sclerosis Complex (TSC), PCDH19)
- Cardiovascular: Myocardial Infarction, Hypertension, Hyperlipidemia (Phase II, III)
- Hematology: Hemophilia (Phase I, II)
- Immunology: Sjogren’s Syndrome (Phase I)
- Respiratory: Asthma (Phase II, III), Idiopathic pulmonary fibrosis (Phase II)
- Orthopaedics / Rheumatology: Total Knee replacement (Medical Device), Axial Spondyloarthritis (Phase II)
- Medical Devices: Covid-19 (Phase II), Influenza (Phase II), Hypertension (Phase II), Gastroparesis (Phase II).
Software Proficiencies
- Electronic Data Capture (EDC): Medidata Rave 5.0, INFORM, eClinical OS, Medrio, Zelta.
- CTMS: ICOMaster, eClinical, Siebel, Edge, Trial Tracker Simple Trials, Bioclinica
- Electronic Trial Master File (eTMF): Veeva Vault, Apttus, Florence, Simple Trials
- IVRS/IWRS: Bracket, Clinphone, Oracle, Endpoint, Suvoda
- Electronic Medical Record (EMR): EPIC, RedCap, Cerner, Medhost
- Microsoft applications (Excel, Word, PowerPoint, Sharepoint and Outlook)
Certifications & Memberships
- PMP Certification - Ongoing
- Barnett International: Good Clinical Practice For Clinical Trials- Expert (2021)
- Association of Clinical Research Professionals (ACRP) – 2023, Member
- The Society of Clinical Research Associates (SoCRA)
References
- Will be provided upon request
Timeline
Senior Clinical Research Associate
Lisata Therapeutics
11.2023 - Current
Senior Clinical Research Associate
ICON Plc
11.2021 - 11.2023
Principal Clinical Research Associate
Pharmaceutical Product Development LLC
07.2020 - 11.2021
Senior Clinical Research Associate
Marinus Pharmaceuticals
12.2019 - 04.2020
Senior Clinical Research Associate
SynteractHCR
05.2019 - 06.2020
Senior Clinical Research Associate III
IQVIA
09.2014 - 05.2019
Clinical Research Associate II
Covance Clinical Research
04.2013 - 09.2014
Bachelor of Science - Cell Biology And Genetics
University of Lagos
Similar Profiles
Anthony J. Varano, Jr.Anthony J. Varano, Jr.
Co-Founder, CEO & Investor at Cervello Therapeutics & Resero TherapeuticsCo-Founder, CEO & Investor at Cervello Therapeutics & Resero Therapeutics
Jennifer ClaytonJennifer Clayton
Vice President - Sales/Marketing/HR at Transdermal Therapeutics, Inc.Vice President - Sales/Marketing/HR at Transdermal Therapeutics, Inc.
ANA JAPARIDZEANA JAPARIDZE
HR Manager at Ariceum Therapeutics GmbHHR Manager at Ariceum Therapeutics GmbH
PARVEEN KUMARIPARVEEN KUMARI
Volunteer Daycare Assistant at Little Sprouts Childcare CentreVolunteer Daycare Assistant at Little Sprouts Childcare Centre
Maddison GrayMaddison Gray
A/g Assistant Director - National Redress Scheme at Department of Social ServicesA/g Assistant Director - National Redress Scheme at Department of Social Services