Lumi Rence
Irvington
Summary
Experienced in Clinical Research with focus on study planning, data collection, and trial management. Familiar with regulatory guidelines and clinical procedure oversight. Strong communication skills coupled with ability to manage multi-faceted projects effectively contribute to comprehensive execution of clinical research studies. Previous work has demonstrated significant improvements in efficiency and accuracy of data collection processes.
Overview
11
11
years of professional experience
Work History
Clinical Research Associate II/ Senior CRA
Innovent Bio
01.2020 - Current
- Monitored and analyzed site performance metrics to identify areas for operational improvement.
- Proactively identified study-related issues and escalated them to the relevant team.
- Managed study supplies (ISF, CRF, etc.), drug supplies, and ensured drug accountability at study sites to support study integrity.
- Perform source data verification according to SDV plan.
- Provide the required monitoring visit reports within required timelines.
- Work with data management to ensure quality of the study data.
- Ensure timely delivery of proper applications/documents for submission to Regulatory Authorities.
- Trained and mentored new members of local study delivery team to enhance team capabilities.
- Contribute to process improvements, knowledge transfer and best practice sharing.
Clinical Research Associate I
Syneos
01.2018 - 01.2020
- Performs and coordinates assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices
- Conducts site visits (pre-study, initiation, interim and close-out visits) to ensure protocol compliance, accurate and thorough data collection, and appropriate study conduct in accordance with Federal Regulations and Good Clinical practices.
- Assist with study start-up process including site contracts/budgeting, negotiation, and IRB submissions
- Developed collaborative relationships with investigative sites and client personnel, ensuring effective monitoring and adherence to study timelines.
- Proactively identifies and works to resolve enrollment and data completion issues.
- Collaborates with team to maintain consistent CRF data quality and discrepancy resolution across sites.
- Oversaw recruitment efforts to meet study goals to meet study recruitment goals by mitigating issues
- Collaborated with team to ensure consistent CRF data quality and timely resolution of discrepancies across sites.
- Assist in the development of study or project plans like Monitoring plan, eCRF completion guidelines, Data management plan and Safety management plan etc.
- Assists with the preparation of study start up materials and tools as requested.
- Attends investigator’s meetings as requested. Assists with preparation as required.
- Reviewed clinical data listings for accuracy and compliance.
- Participated in investigator meetings to discuss study progress as requested. Assists with preparation as required.
Clinical Study Associate
AstraZeneca
01.2016 - 01.2018
- Be responsible for setting up and administrating the eTMF or set up the paper TMF files
- Maintained and completed the paper and electronic TMF for documents and appropriate filing.
- To maintain and complete the paper and electronic TMF for documents and appropriate filing of documents
- Identified and prepared documents for country requirements in the framework of regulatory submissions.
- Identified and prepared documents for country-specific regulatory submission requirements
- Reviewed and conducted quality checks on the TMF for quality and completeness before audits and inspections.
- To set up, organize and maintain clinical study documentation (e.g., Main Study Files, CRFs, etc.) including preparation for internal/external audits, final reconciliation and archival.
- To process Data Collection Forms i.e. log in, tracking, quality control as appropriate for the study.
- Assisted in quality control audits of clinical study documentation including Main Study Files and CRF Files.
Education
Bachelor of Science -
Associate in health science -
Certified clinical research associate -
ACRP
Skills
- Regulatory submissions
- Clinical monitoring
- Source data verification
- Data management plan
- Drug accountability
- Site management
- Effective communication
- Problem solving
- Good clinical practice
- Accountability
- Data collection
- Site monitoring
- Source document verification
- Clinical trial management
- Electronic data capture
Therapeutic Area Of Expertise
- Cardiovascular - Hypertension, Myocardial infarction
- Medical Device - Mitral Valve, In Vitro diagnostics, GI Stent
- Endocrine - Diabetes Mellitus Type 2
- Respiratory – Asthma
- Oncology – Triple Negative Breast Cancer, Ovarian cancer, prostate cancer
- Neurology - Alzheimer's disease, Multiple sclerosis, Stroke
- Infectious Diseases - HIV
Summary Of Experience
- Cardiovascular - Hypertension, Myocardial infarction
- Medical Device - Mitral Valve, In Vitro diagnostics, GI Stent
- Endocrine - Diabetes Mellitus Type 2
- Respiratory – Asthma
- Oncology – Triple Negative Breast Cancer, Ovarian cancer, prostate cancer
- Neurology - Alzheimer's disease, Multiple sclerosis, Stroke
- Infectious Diseases - HIV
Timeline
Clinical Research Associate II/ Senior CRA
Innovent Bio
01.2020 - Current
Clinical Research Associate I
Syneos
01.2018 - 01.2020
Clinical Study Associate
AstraZeneca
01.2016 - 01.2018
Bachelor of Science -
Associate in health science -
Certified clinical research associate -
ACRP