Sola Olaniran
Ramsey
Summary
Senior CRA responsible for oversight and monitoring activities that will lead to the successful execution of clinical studies. Prepares, leads, and executes clinical operations study tasks, including documents, initiation, monitoring, and completion of clinical studies for verification and/or validation.
Overview
13
13
years of professional experience
Work History
Senior Clinical Research Associate
Novartis Pharmaceuticals
09.2022 - Current
- Frontline liaison between Novartis and sites to ensure successful collaboration, meeting Novartis expectations on milestones and deliverables with a true ownership mindset.
- Manages assigned study sites, conducting phase I-IV protocols according to the Monitoring Plan and Novartis procedures.
- Performs Site Initiation Visits, and ensures site personnel is fully trained on all trial-related aspects. Performs continuous training for amendments and new site personnel as required. Re-trains site personnel as appropriate.
- Conducts continuous site monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol, ICH/GCP, global and local regulation including Health Authorities, IRB/EC, data privacy requirements, global and local processes as applicable. Documentation according to GDP and Novartis standards.
- Identifies deficiencies in site processes and monitor site processes performed outside the site, works in close collaboration with site on risks mitigation and process improvements.
- Promotes a compliance culture advocating adherence to highest standards and ethical integrity, always ensuring human subject protection and reliability of trial results.
- Identify deficiencies in site process, work in close collaboration with site on risk mitigation.
- Establish a strong partnership and true collaboration with the site, to increase patient density and decrease issues at site.
- Early engagement with site on patient inventory and patient flow in advance of SIV in close collaboration with global and local study team.
- Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements.
- Attends onboarding-, disease indication and project specific training and general CRA training as required.
- Proactively collaborates with the SSO Clinical Project Manager (CPM) and CRA Manager as well as MSL, CRMA and medical advisor to ensure optimal recruitment, site development and data quality.
- Ensures that relevant site insights are shared with internal stakeholders such as site partnership manager, medical advisor, MSL and CRMA etc. to improve one Novartis approach to sites.
- Participates in audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines.
- Collaborates with internal stakeholders and site personnel to manage data query resolution process and to ensure timely and accurate data entry.
- Ensures the site Investigator Folder is up to date. Responsible for collecting essential documents from site and accountable to keep sTMF(s) up to date.
Senior Clinical Research Associate
TrialSpark (Clinical Resource Network)
11.2021 - 09.2022
- Served as a primary point of communication between TrialSpark and clinical sites including dissemination of information to the project team, investigators, study coordinators, and physicians.
- Participates in the investigator recruitment process. Performs site evaluation visits of potential investigators. Evaluates the capability of the site to successfully manage and conduct the clinical study.
- Reviews the quality and integrity of the clinical data through direct data capture (DDC) and on-site source verification. Works with sites to resolve data queries.
- Conducts qualifications, initiation, and interim visits. Ensures all appropriate site staff are trained, have access to required electronic systems, and are informed of data collection, GCP, protocol, and reporting requirements.
- Resolve Queries of CRF data with study personnel
- Managed assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements.
- Ensures that required essential documents are complete and in place, according to ICH-GCP and applicable regulations. Conducts on-site file reviews per project specifications.
- Facilitates effective communication between investigative sites, the client company, and the TrialSpark project team through written, oral, and/or electronic contacts.
Senior Clinical Research Associate
Merck
03.2020 - 11.2021
- Managed clinical study sites with strong customer service orientation.
- Managed site selection, subject recruitment, study payments, monitoring, and closeout visits.
- Provided or led project-specific clinical study support.
- Developed project-specific documents, protocols, informed consents, monitoring plans, study budgets, and other study-related documents.
- Proactively identified and resolved clinical project issues and participated in process improvement initiatives, as applicable.
- Engages with study investigators, vendors, and internal/external stakeholders.
- Critically reviewed on-site files and source documents for completeness, accuracy, and compliance.
- Identified deficiencies and discrepancies and provided effective remedial training/corrective action as required.
- Established and manages clinical trial master files (TMF).
- Assisted in developing clinical trial timelines and effectively demonstrated adherence to deliverables.
- Worked closely with Clinical Data Management to develop case report forms and manage study data in electronic data capture systems. Effectively manage query resolution.
- Coordinated and participated in investigator meetings and other site training activities.
Clinical Research Associate II
Merck
03.2017 - 03.2020
- Organized and performed monitoring and logistics of clinical trials.
- Participated in the selection of investigative centers and in contract negotiation, including costs.
- Assisted project managers in the coordination of clinical trials and with regulatory filing submissions.
- Participated in writing important documents related to clinical trials, including source documents and other trial documentation and follow-up reports.
- Ensured that the trials run smoothly in the different investigative centers.
- Worked in close collaboration with the different project team members to ensure all monitoring activities are conducted according to study requirements.
- Managed and trained site personnel on therapeutic area, protocol requirements, proper source documentation, and case report form completion.
- Managed, prepared, sent, tracked, and returned investigational supplies at individual sites.
- Monitored and documented investigational product dispensing, inventory, and reconciliation.
- Monitored and documented laboratory sample storage and shipment.
Clinical Research Associate I
PPD
05.2015 - 03.2017
- Served as a primary point of communication between PPD and clinical sites including dissemination of information to the project team, investigators, study coordinators, and physicians.
- Participated in initial/ongoing training of site personnel and helped generate initial/ongoing study excitement and promote achieving enrollment targets for sites.
- Maintained site upkeep of data query resolution and ongoing entry and updates of site information in databases and IRB interface.
- Conducted Site Initiation Visits, Interim Monitoring Visits, and Site Close-out Visits.
- Assisted in the collection and maintenance of essential study site regulatory documents and participated in IRB submissions.
- Participated in the development and execution of patient recruitment efforts with each site.
- Ensured quality of data submitted from assigned study sites and assured timely submission of data, including appropriate reporting and follow-up for all safety events.
- Prepared and submitted quality written reports in a timely, concise, and objective manner.
- Worked with study sites to ensure compliance with the protocol and overall clinical objectives while maintaining rapport.
- Participated in the development, maintenance, and distribution of Clinical Standard Operating Procedures (SOPs), Case Report Forms (CRFs), and other documents.
Clinical Research Coordinator
Mayo Clinic
01.2013 - 05.2015
- Conducted clinical studies according to FDA/GCP and ICH regulations and guidelines.
- Provided medical care to patients, always ensuring patient safety comes first.
- Performed all defined study activities.
- Recorded all patient information and results from tests as per protocol on required forms.
- Completed IP accountability logs and associated information.
- Reported suspected non-compliance to relevant site staff.
- Ensured that IRB approval is obtained prior to study initiation and IRB requirements are met throughout the study.
- Promoted the company and built a positive relationship with patients to ensure retention.
- Attended site initiation meetings and all other relevant meetings to receive training on protocol.
- Called patients, did patient bookings, and followed-up calls to confirm bookings or provide information or results.
Education
Master of Science - Nursing
Rasmussen University
Bloomington, MNBachelor of Science - Nursing
Rasmussen University
Bloomington, MNBachelor of Science - Health Care Management
Rasmussen University
Saint Cloud, MNSkills
- 8 years of clinical research experience
- Detail-oriented
- Regulatory compliance
- Excellent organizational skills, strong interpersonal and communication skills, and strong problem-solving skills
- Flexibility with changing priorities
- Phases I-III clinical research experience
- Ability to efficiently perform and prioritize multiple tasks
- Familiarity with medical and pharmaceutical industry, and related terminology and practices
- Extensive knowledge of FDA regulations and their practical implementation
- Ability to travel, including by air or by car, on short notice
- Computer proficiency in Microsoft Word, Excel, and PowerPoint
- Ability to understand complex written and oral instructions
Therapeutic Areas
- Oncology: Solid Tumor, Leukemia, Non-Small Cell Lung Cancer, Breast Cancer, and Colon Cancer
- Infectious Disease: Chlamydia and Herpes
- Neurology: Parkinson's Disease, Multiple Sclerosis, and Schizophrenia
- Endocrinology: Diabetes
- Medical Device: Cardiac Pacemaker
- Cardiology: Cholesterol, Heart failure, Atrial Fibrillation
Timeline
Senior Clinical Research Associate
Novartis Pharmaceuticals
09.2022 - Current
Senior Clinical Research Associate
TrialSpark (Clinical Resource Network)
11.2021 - 09.2022
Senior Clinical Research Associate
Merck
03.2020 - 11.2021
Clinical Research Associate II
Merck
03.2017 - 03.2020
Clinical Research Associate I
PPD
05.2015 - 03.2017
Clinical Research Coordinator
Mayo Clinic
01.2013 - 05.2015
Master of Science - Nursing
Rasmussen University
Bachelor of Science - Nursing
Rasmussen University
Bachelor of Science - Health Care Management
Rasmussen University