OLA JOHNSON
Summary
A challenge-driven, adaptable, and enthusiastic individual who has a BSc in Healthcare & Health Science and valuable work experience in clinical research and the healthcare environment. I display intellectual agility, and confidence and also enjoy being an integral part of leading a team. Possesses the ability to work accurately and methodically even under pressure and able to communicate efficiently. I have a strong interest and great passion for drug development and clinical trials.
Overview
17
17
years of professional experience
1
1
Certification
Work history
SENIOR CLINICAL RESEARCH ASSOCIATE
KCR CRO
10.2023 - Current
- Fostered strong relationships with investigators, enhancing collaborative efforts.
- Performed Pre-Study visit, Site Initiation Visit, Routine monitoring visit and Close out visits.
- Maintained meticulous documentation for easy reference and audit readiness. Upload clinical trial documents in eTMF and review TMF for completeness.
- Managed clinical research projects to ensure compliance with regulatory bodies.
- Coordinated clinical study visits, ensuring smooth operations.
- Performed site initiations to ensure preparedness before study commencement.
- Streamlined communication amongst team members, fostering a cohesive work environment.
- Prepared Visit Reports and contributes information for Status Reports for sponsors.
- Monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements, and assurance of good site performance.
- Managed assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements.
- Reviewed and verify eCRFs and other clinical data, for completeness and accuracy; generate queries, resolved queries of CRF data with the study personnel.
- Performed necessary administrative functions (e.g. submission of expense reports, entering time).
SENIOR CLINICAL RESEARCH ASSOCIATE
Synteract, a Syneos Health Company
06.2022 - 10.2023
- Performed site monitoring visits (selection, initiation, monitoring and closeout visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines
- Work with sites to adapt, drive and track subject recruitment plan in line with project needs to enhance predictability
- Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues
- Review and verify eCRFs and other clinical data, for completeness and accuracy; generate queries, resolved queries of CRF data with the study personnel
- 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 as appropriate
- Monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements, and assurance of good site performance
- Create and maintain 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
- Collaborate and liaise with study team members for project execution support as appropriate
- Conduct appropriate IMP management at study sites
- Review site files to ensure they are accurate and complete and ensure the ongoing management of the Trial Master File
- Upload clinical trial documents in eTMF and review TMF for completeness
- Interaction and general communication with clinical investigational site staff including the Principal Investigator (PI)
SENIOR CLINICAL RESEARCH ASSOCIATE I
Synteract
03.2019 - 05.2022
- Managed all aspects of a clinical trial at all assigned clinical sites to ensure patient safety, adherence to appropriate safety regulations and data integrity
- Prepared and conducted study initiation, remote and on-site monitoring, and close-out monitoring visits at investigator sites
- Maintains/reviews regulatory documents as required
- Prepared Visit Reports and contributes information for Status Reports for sponsors
- Monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements, and assurance of good site performance
- Managed assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements
- Reviewed and verify eCRFs and other clinical data, for completeness and accuracy; generate queries, resolved queries of CRF data with the study personnel
- Upload clinical trial documents in eTMF and review TMF for completeness
- Performed necessary administrative functions (e.g Submission of expense reports, entering time)
CLINICAL RESEARCH ASSOCIATE II
Quintiles/IQVIA
01.2015 - 02.2019
- Managed all aspects of a clinical trial at all assigned clinical sites to ensure patient safety, adherence to appropriate safety regulations and data integrity
- Prepared and conducted study initiation, remote and on-site monitoring and close-out monitoring visits at investigator sites
- Maintains/reviews regulatory documents as required
- Prepared Visit Reports and contributes information for Status Reports for sponsors
- Monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements, and assurance of good site performance
- Managed assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements
- Reviewed and verify eCRFs and other clinical data, for completeness and accuracy; generate queries, resolved queries of CRF data with the study personnel
- Upload clinical trial documents in eTMF and review TMF for completeness
- Performed necessary administrative functions (e.g Submission of expense reports, entering time)
CLINICAL RESEARCH ASSOCIATE II
Clintec
02.2013 - 12.2014
- Performed Pre-Study visit, Site Initiation Visit, Routine monitoring visit and Close out visits
- Monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines, and other applicable regulatory requirements, and assurance of good site performance
- Managed assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements
- Obtained and reviewed regulatory and administrative documents from investigative sites
- Reviewed and verify CRFs and other clinical data, for completeness and accuracy; generate queries
- Resolved Queries of CRF data with the study personnel
- Performed necessary administrative functions (e.g Submission of expense reports, entering time)
- Prepared Visit Reports and contributes information for Status Reports for sponsors
- Trained/Mentored junior CRAs on monitoring, internal procedures, and query resolution
CLINICAL RESEARCH ASSOCIATE
Clintec
01.2012 - 02.2013
- Managed all aspects of a clinical trial at all assigned clinical sites to ensure patient safety, adherence to appropriate safety regulations and data integrity
- Managed query resolution process with sites and Premier Research Data Management
- Assists project team with assessing project feasibility and recruitment
- Prepared and conduct on-site qualification, study initiation, interim monitoring, and close-out monitoring visits at investigator sites
- Maintains/reviews regulatory documents as required
- Prepared Visit Reports and contributes information for Status Reports for sponsors
- Assists in the preparation and development of materials for Investigators' Meeting; participates in Investigators' Meeting as designated by Project Manager
- Managed investigative sites via telephone calls between visits
CLINICAL TRIAL ASSISTANT
Leeds Teaching Hospital
12.2010 - 01.2012
- Performed clinical research database duties such as ensuring all study data is processed, entered, and validated in accordance with clinical study guidelines
- Assists with protocol deviation tracking and adverse event reporting
- Coordinate with the clinical project team the distribution, retrieval and review of regulatory documents required for initiation of a clinical trial
- Assisted clinical research associates in preparing and tracking investigational product supplies, packaging, and shipment requests and circulating these requests for appropriate approvals
- Secured necessary administrative (non-drug) supplies for clinical trials and processes site requests for shipping supplies
- Ensured required clinical trial documents (GCP Certificate, CVs etc.) are current
- Supports clinical monitoring staff for visit preparation regarding regulatory document tracking and other study file correspondence
- Performed additional duties and assignments as requested
SUPPORT WORKER
Four Seasons Health Care
07.2008 - 11.2010
- Assisted permanent staff members with the provision of care to service users
- Assisted service user with all activities of daily living to include personal hygiene, nutrition
- Moving and Handling of the service users, including where necessary the use of hoist, slide sheets
- Made Report on the service user's condition to a more senior staff
- Maintained the health and safety of clients and others in the work environment
- Full training in moving and handling, Food hygiene, health and safety, safeguarding in vulnerable adults and children and First aid
- Certificate awarded
Education
Bachelor of Science - Healthcare and Health Science
The Open University
Certificate - Health Science
The Open University
Skills
- Proficient in
- Microsoft Office Suite (Word, Excel, PowerPoint)
- Good Clinical Practices
- Trial management
- Informed consent
- Research SOPs understanding
- Study protocols
- Report writing
- Subject tracking tools
- Database locking
- Coordinating site operations
- Pre-study visits
- Teamwork and Collaboration
- Interpersonal Communication
- Attention to Detail
Certification
- Serious Breaches
- RECISIT 1.1 Criteria
- General Data Protection Regulation (GDPR)
- General ICH- GCP
- Oncology Training
- Investigational Medicinal Product Monitoring
Therapeutic Areas
- Dermatology/ Lymphoedema/ III
- Infectious Disease/ Hepatitis C Virus/ III
- Endocrinology/ Growth Hormone Deficiency/ III
- Gastrointestinal/ Crohns Disease/ II
- Cardiovascular/ Myocardial Infarction/ II
- Neurology/ Neuropathic Pain/ III
- Oncology/ Metastatic Breast cancer/ IV
- Oncology/ B-Cell Chronic Lymphocytic Leukemia/ I
- Oncology/ Gastric cancer/ III
- Oncology/ Carcinoma of unknown primary site/ III
- Hematology/ Hemophilia A / II & III
- Oncology/ Ovarian Cancer/ III
- Liver Disease/ Non-alcoholic Fatty Liver Disease/ II
- Rare & Orphan Disease/ Wilson Disease/ III
- Infectious Disease/ Hepatitis B/ I & II
- Oncology/ Cutaneous & Mucosal Melanoma/ II
- Oncology/ Relapsed & Refractory Diffuse Large B-Cell Lymphoma/ III
- Neurology/ Muscular Dystrophy Duchenne/ II
- Oncology/Hemato-oncology / Solid Tumors / I/II
- Oncology/Hemato-oncology / Advanced Solid Tumors / I
- Oncology/Hemato-oncology / Solid Tumors / I
References
References available upon request.
Timeline
SENIOR CLINICAL RESEARCH ASSOCIATE
KCR CRO
10.2023 - Current
SENIOR CLINICAL RESEARCH ASSOCIATE
Synteract, a Syneos Health Company
06.2022 - 10.2023
SENIOR CLINICAL RESEARCH ASSOCIATE I
Synteract
03.2019 - 05.2022
CLINICAL RESEARCH ASSOCIATE II
Quintiles/IQVIA
01.2015 - 02.2019
CLINICAL RESEARCH ASSOCIATE II
Clintec
02.2013 - 12.2014
CLINICAL RESEARCH ASSOCIATE
Clintec
01.2012 - 02.2013
CLINICAL TRIAL ASSISTANT
Leeds Teaching Hospital
12.2010 - 01.2012
SUPPORT WORKER
Four Seasons Health Care
07.2008 - 11.2010
Bachelor of Science - Healthcare and Health Science
The Open University
Certificate - Health Science
The Open University
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