Kelvin Wairimu
Federal Way,WA
Summary
Data Analyst who is well-versed in various statistical methods such as descriptive and influential statistics. Skillful in identifying data issues and monitoring existing metrics.
Overview
6
6
years of professional experience
Work History
Clinical Research Assistant
Care Access
06.2022 - Current
- Recruit study patients by calling subjects from database and potential volunteers (phone, email, post, etc.) and document contact accordingly.
- Screen patient referrals, databases and physician requests to identify prospective candidates for research studies.
- Conduct informed consent and research interviews with research participants.
- Managed 5 active sites and coordinated all the necessary appointments with my study coordinators.
- Extract data from source documents and complete case report forms.
- Perform clerical duties in preparation of regulatory documents, obtained signatures from required and appropriate personnel as requested.
- Data entry in electronic case report forms.
- Schedule study visits with subjects, contact with reminders.
- Request medical records of potential and current research participants.
- Process study payments, update subject compensation tracker.
- Perform clerical duties, such as data entry, answering phones and filing.
Medical Research Assistant
University of Washington East Lake Research Lab
04.2021 - 05.2021
- Ensuring that all patients have signed Informed Consent form prior to their participation in the study
- Data management of diseases reports
- Monitoring of patients records electronically using EDC systems
- Management of courier services in relation to blood sample transportation
- Follow-up and resolve any issues arising from monitoring visits
- Track completed CRFs sent to Data Management issued and resolved data queries
- Used critical thinking to break down problems, evaluate solutions and make decisions.
- Maintain in-house project files to ensure complete documentation, including all correspondence according to
- IRB protocols
- Arranged monitoring visits at appropriate time intervals (depending on rate of recruitment, number of patients enrolled and complexity of the study during remote surveys)
- Ensured that Serious Adverse Events are reported according to SOPs
- In house phlebotomy services with over 3000 successful blood draws
- Carefully handled and disposed of biological hazardous materials following strict safety procedures to avoid contamination.
- Trained and mentored new staff to achieve efficiency and maintain daily operational consistency.
Clinical Research Associate
The Clinical Research Training Institute
Houston, TX
11.2020 - 04.2021
- Site monitoring, review and verification of site procedures and documentation
- Support protocol and adherence to federal regulations as well as ICH-GCP guidelines
- Identification of potential investigators
- Study drug inventory across multiple sites
- Investigation and resolution of audit issues and queries
- Source document verification of subject data and query resolution
- Applied extensive knowledge to troubleshoot and resolve regulatory document issues.
- Reviewed clinical data, source documentation, case report forms and investigative site regulatory files to verify accuracy and completion.
- Site Selection utilizing site evaluation and validation processes
- Developing and maintaining excellent relationships with physicians/ investigators and study coordinators.
Certified Clinical Medical Assistant
CVS Minute Clinic
08.2018 - 10.2020
- Prepared and administered medications to alleviate patient symptoms
- Prepared rooms between patients, using aseptic technique to prevent infections and cross-contamination
- Conferred with a multidisciplinary healthcare team to help effectively manage patient conditions with regular testing and vitals assessments
- Performed COVID-19 Testing, initial response-screening
- Checked patient vitals such as temperature, blood pressure and blood sugar to stay on top of symptoms and kept informed changes
- Checking patients and collecting nasal swabs on patients and running the test for lab assessment using
- Promoted office efficiency, coordinating charts, completing insurance forms, and helping patients with diverse needs
- Supported duties for diagnostic and technical treatment procedures such as blood draws and setting up and operating special medical equipment and apparatus
- Collected all pertinent data and calculations to aid the physician in interpreting results
- Prepared blood, urine, stool, and sputum lab specimens for diagnostic evaluation
- Delivered individualized patient care by recording vital signs, documenting observations, administering treatments, and evaluating patient needs.
- Assisted with routine checks and diagnostic testing by collecting and processing specimens.
Clinical Research Associate
Ampath & Partners
01.2014 - 01.2017
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Facilitated quality of clinical trials by establishing project schedules and monitoring support to encourage accuracy and efficiency.
- Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
- Provided clinicians with data to conduct clinical trials and determine methods to prevent, screen for, diagnose and treat disease.
- Oversaw project developments to provide quality deliverables while maintaining optimal efficiency.
Education
No Degree - Pre-Medicine
Texas State University
San Marcos, TXAssociate Degree in Data Analytics - Data Analytics
Austin Peay State University
Clarksville, TN10.2022
Associates - Clinical Research Associates
The Clinical Research Training Institute
2021
Some College (No Degree) - Certified Medical Assistant
Central Texas Nursing Inc
Austin, TXBachelor of Science - Medical Psychology
Moi University School of Medicine
2017
Skills
- SUMMARY OF SKILLS & QUALIFICATIONS:
- Data Science with R Programming
- Technical Design Documentation
- Sales and Marketing Support
- Advanced Excel Spreadsheet Functions
- Trend Variations
- Word Processing
- Database Management
- Operating EKG Equipment and analysis of the results
- Phlebotomy experience
- Sound knowledge of Good Clinical Practices (ICH-GCP’s) and FDA regulations
- Excellent understanding of HIPPA and maintenance of confidentiality
- Advanced medical/scientific knowledge and medical terminologies
- Use of electronic data capture systems (EDC)
- Clinical Trial Management Systems (CTMS) and IVRS systems
- Conversant with design and review of case report form (CRF)
- Site Monitoring (including PSVs, SIVs, IMVs and COVs) to meet study expectations
- Source data/document verification (SDV)
Timeline
Clinical Research Assistant
Care Access
06.2022 - Current
Medical Research Assistant
University of Washington East Lake Research Lab
04.2021 - 05.2021
Clinical Research Associate
The Clinical Research Training Institute
11.2020 - 04.2021
Certified Clinical Medical Assistant
CVS Minute Clinic
08.2018 - 10.2020
Clinical Research Associate
Ampath & Partners
01.2014 - 01.2017
No Degree - Pre-Medicine
Texas State University
Associate Degree in Data Analytics - Data Analytics
Austin Peay State University
Associates - Clinical Research Associates
The Clinical Research Training Institute
Some College (No Degree) - Certified Medical Assistant
Central Texas Nursing Inc
Bachelor of Science - Medical Psychology
Moi University School of Medicine