BENARD R. KIMWEI
Burnaby,Canada
Summary
Accomplished Senior Clinical Research Coordinator with a proven track record at UBC Hospital, adept in technology and clinical trial management systems. Demonstrates an analytical mindset and exceptional organizational skills, ensuring project success and compliance. Excelled in coordinating multi-site trials and enhancing recruitment strategies, significantly contributing to research advancements.
Overview
17
17
years of professional experience
1
1
Certification
Work History
SENIOR CLINICAL RESEARCH COORDINATOR
UBC HOSPITAL- MS CLINIC TRIAL- DIVISION OF NEUROLOGY
Vancouver, British Columbia
03.2023 - Current
- Managed all aspects of clinical trial execution, including patient recruitment, data collection, and adverse event reporting for neurology studies on multiple sclerosis.
- Maintains direct communication with sponsors and CROs, facilitating efficient study operations for ten clinical trials.
- Improves compliance with ICH-GCP guidelines, resulting in the successful conduct of research projects annually.
- Handles a budget of $2.5 million for multiple clinical trials, while ensuring rigorous financial oversight.
- Oversee junior research coordinators and research assistants, which has enhanced the overall efficiency of the MS Clinical Trials team.
- Coordinated with external stakeholders, including pharmaceutical representatives, and regulatory bodies, to streamline trial processes.
- Executed documentation for clinical studies in alignment with regulatory and safety standards.
- Managed a database of 200 patients, ensuring accurate record-keeping and compliance during clinical trials.
- Facilitated the training of new staff members on clinical research protocols, improving project adherence, and efficiency.
- Oversaw the collection of several biomarker samples in compliance with research protocols, ensuring data integrity.
- Successfully monitored 40 clinical trial participants, overseeing real-time updates, and addressing any adverse events promptly.
- Executed and supervised 12 clinical research studies at a time, from the recruitment of subjects to the end of the study.
- Reviewed source documentation for accuracy of data entered into eCRFs.
- Streamlined data collection via EDC Rave, improving data management efficiency by 25%
- Conducted screening interviews to determine eligibility of possible subjects.
- Increased participant recruitment by 20% through effective screening strategies for industry-sponsored studies.
- Educated participants on studies and anticipated outcomes.
- Participated in safety review boards to evaluate the safety profile of investigational products.
- Monitored study progress and documented adverse events in accordance with protocol guidelines.
- Trained new team members on the principles of Good Clinical Practice and ICH regulations.
- Performed quality control checks on eCRF data by reviewing discrepancies reported by Data Management staff or generated from database queries.
- Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
- Monitored subject enrollment and tracked dropout details.
- Ensured that all research activities were conducted according to protocols and in compliance with local laws and regulations as well as GCP guidelines.
- Developed and maintained regulatory documents for clinical trials.
- Completed day-to-day duties accurately and efficiently.
- Facilitated communication between research personnel at multiple departments.
CLINICAL RESEARCH COORDINATOR
BURNABY& RICHMOND HOSPITALS- ONCOLOGY
11.2018 - 05.2023
- Managed overall oncology research studies, leading to the successful closure of five trials ahead of schedule.
- Maintained accurate up-to-date tracking logs for all aspects of clinical research activities including but not limited to adverse events, serious adverse events, concomitant medications, lab results .
- Collaborated with the PI to determine the eligibility of potential subjects through screening interviews and reviews of medical records.
- Demonstrated vigilance in patient safety, protocol compliance, and data quality by adhering to GCP and study protocols.
- Ensured that safety reports are shared accordingly with the study team and reported to the ethics committee/IRB, as per the PI.
- Oversaw the completion of the case report forms (CRFs) per Health Canada and FDA guidelines, and reviewed them against the patient's record for completeness and accuracy.
- Facilitated resolution of protocol deviations or violations reported by sites or detected through monitoring activities.
- Compiled trial related documents into a master file as required by sponsor or regulatory agency.
- Assessed records of each patient, reviewed databases and checked referrals to locate potential research study participants.
- Monitored subject enrollment and tracked dropout details.
- Placed orders for medications to be used in studies.
- Provided training to study staff on protocol requirements and GCP regulations.
- Kept patient care protocols and clinical trial operations in compliance.
- Developed and maintained accurate and timely study databases.
- Conducted screening interviews to determine eligibility of possible subjects.
- Created and updated source documents
- Communicated effectively with investigators, study staff, sponsors, vendors, IRB personnel, and other stakeholders throughout the life cycle of the trial.
- Organized investigator meetings; developed meeting agendas; created presentations; tracked action items from meetings; coordinated follow-up communications after meetings.
- Assisted in the preparation of Institutional Review Board submissions for clinical trials.
- Demonstrated strong problem-solving skills, resolving issues efficiently and effectively.
- Utilized various software and tools to streamline processes and optimize performance.
- Collaborated closely with team members to achieve project objectives and meet deadlines.
- Worked effectively in team environments to make the workplace more productive.
CLINICAL RESEARCH COORDINATOR
UBC- DEPT OF HEM/ONC/BMT, BC CHILDREN'S HOSPITAL
12.2021 - 03.2023
- Responsible for the day-to-day operation of the multi-site, investigator-initiated project.
- Prepared documents for submission to Institutional Review Board (IRB) and ancillary review committees for initial approval, changes in research, and continuing review; reviewed unanticipated problems to determine if prompt reporting is required, and compiled promptly reportable submissions for review committees.
- Adhered to standards in areas involving data collection, research protocols, and regulatory reporting.
- Placed orders for medications to be used in studies.
- Provided support to field staff during data collection activities, including training on proper data entry procedures.
- Reviewed consent forms for accuracy and completeness prior to participant enrollment in the study.
- Managed a database of research participants and tracked their progress throughout the study.
- Coordinated the recruitment of study participants through various channels, such as targeted advertisements and referrals from community partners.
- Conducted screening interviews to determine eligibility of possible subjects.
- Collaborated with sponsors and investigators to carry out efficient and fully compliant research trials.
- Maintained accurate records of all documents related to the research process, including consent forms, interview notes, survey results.
- Monitored subject enrollment and tracked dropout details.
- Participated in weekly team meetings to discuss progress on current projects and plan future initiatives.
- Collected, processed and delivered specimens from trial participants.
- Collected and documented data accurately, ensuring the integrity and reliability of research information.
- Draft correspondence between investigators, sponsors, IRBs, and universities regarding project-related matters.
- Collaborated with other research teams to share resources, coordinate efforts, and ensure quality control across multiple projects.
CLINICAL RESEARCH COORDINATOR
MEDICAL ARTS HEALTH RESEARCH GROUP
12.2020 - 12.2021
- Company Overview: W
- VANCOUVER
- Conducted all study-related activities in accordance with study protocol and sponsor's instructions, institutional policy and standard operating procedures, Good Clinical Practice (GCP standards), ethical requirements, and applicable national and international regulations
- Implements research protocol and all required procedures within scope of qualifications and under delegation of PI
- Diligently consulted with Research Nurses on data, protocol, or patent assessment issues
- Established a strong, positive, and supportive relationship with each participant, fostering compliance to protocol requirements, trust and acknowledges importance of each participant's role as a research volunteer
- Oversaw and participated directly in timely (real-time) study data collection, query resolution, analysis, and quality assurance throughout trial
- Ensured that essential documents are archived following study completion
- Performed data management activities on both paper-based and electronic data capture (EDC) studies, in accordance with Good Data Management Practices (attributable, legible, contemporaneous, original, and accurate - ALCOA), Good Clinical Practice (GCP standards, company research policies and procedures, and applicable research and privacy legislation)
- Reviewed CRF data for accuracy and completeness, enters data in accordance with study-specific requirements, responds to and resolves queries in accordance with protocol and/or contractual time specifications, manages discrepancies, and addresses any ad-hoc reporting requirements as per each study's needs
- Coordinated data flow internally and externally and collected data from all sources (electronic and paper) including, but not limited to, electronic health records, other databases, and paper medical records/charts
- Assisted Principal Investigators and study staff in creation of data reports for quality assurance purposes
- Ensured ongoing and precise documents communication with sponsors, monitors, and regulatory bodies, as required, for broad range of study activities including, but not limited to, safety reporting
- Developed protocol-specific case report forms, informed consent documents, and source document tools
- Educated other healthcare professionals, community, potential study participants, and their families about clinical trials
- Maintained investigational drug/device accountability records and ensures investigational products are stored and accessed in accordance with Sponsor instruction
- Provided general office administration, correspondence
- W
- VANCOUVER
RESEARCH ASSOCIATE& STUDY START UP COORDINATOR
BOSTON SCIENTIFIC- MEDICAL DEVICE COMPANY
06.2016 - 06.2018
- Collaborated with cross-functional teams to identify areas of improvement in existing processes.
- Actively participated in weekly meetings with the research team to discuss progress towards project goals.
- Supplied quality control data for regulatory submissions to support corrective actions.
- Identified and fixed issues with lab equipment to achieve more accurate lab results.
FOOD SAFETY, QUALITY AND REG, AFFAIRS SPECIALIST
CARGILL MEAT LIMITED COMPANY
03.2008 - 11.2014
- Implemented process improvements to increase efficiency and reduce costs.
- Assisted in developing strategies to increase customer satisfaction levels.
- Worked closely with human resources to support employee management and organizational planning.
- Coordinated with other departments to ensure efficient workflow processes.
- Developed and implemented food safety policies, procedures, and best practices in accordance with local laws.
- Organized training sessions for staff members regarding safe food handling practices.
- Managed pest control programs including monitoring traps and documenting findings.
- Trained staff on proper hygiene, sanitation, and food handling protocols.
- Created SOP's for cleaning and sanitizing surfaces as well as storing and preparing foods safely.
- Reviewed HACCP plans and monitored implementation to verify that they are functioning according to plan.
- Conducted company-wide trainings in safety procedures, delivering tailored documentation for future reference and review.
- Performed internal audits to ensure that all processes were being followed correctly.
- Provided guidance to management on areas needing improvement with regard to food safety requirements.
- Monitored the use of personal protective equipment by employees.
- Verified that suppliers are meeting established standards prior to accepting deliveries.
- Communicated any nonconformities promptly to management and documented corrective actions taken.
- Performed daily temperature checks of freezers and refrigerators and documented results.
- Recorded or compiled test results to prepare graphs, charts or reports.
- Identified potential sources of contamination or cross-contamination within the facility and implemented preventive measures accordingly.
- Conducted regular inspections of kitchen premises and equipment to identify potential risks and hazards.
- Maintained compliance with standards by keeping documents, policies, and records current and accurate.
Education
Bachelor of Science - Biological Sciences
Athabasca University
01.2018
Advanced Degree - Chemical Lab. Technology-Pharmaceuticals
Seneca College @York University
01.2008
Skills
- Excellent organizational skills
- Willingness to continually self-educate
- Coordinating site operations
- Diligent and attention to detail
- Good written and verbal communication skills
- Strong analytical skills
Certification
Society of Clinical Research Association (SOCRA), CCRP
Timeline
SENIOR CLINICAL RESEARCH COORDINATOR
UBC HOSPITAL- MS CLINIC TRIAL- DIVISION OF NEUROLOGY
03.2023 - Current
CLINICAL RESEARCH COORDINATOR
UBC- DEPT OF HEM/ONC/BMT, BC CHILDREN'S HOSPITAL
12.2021 - 03.2023
CLINICAL RESEARCH COORDINATOR
MEDICAL ARTS HEALTH RESEARCH GROUP
12.2020 - 12.2021
CLINICAL RESEARCH COORDINATOR
BURNABY& RICHMOND HOSPITALS- ONCOLOGY
11.2018 - 05.2023
RESEARCH ASSOCIATE& STUDY START UP COORDINATOR
BOSTON SCIENTIFIC- MEDICAL DEVICE COMPANY
06.2016 - 06.2018
FOOD SAFETY, QUALITY AND REG, AFFAIRS SPECIALIST
CARGILL MEAT LIMITED COMPANY
03.2008 - 11.2014
Bachelor of Science - Biological Sciences
Athabasca University
Advanced Degree - Chemical Lab. Technology-Pharmaceuticals
Seneca College @York University
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