Karen Kate Tumale
Clinical Trial Educator 2
Esperanza,Sultan Kudarat
Summary
Karen Kate Tumale is a Clinical Trial Educator 2 (CTE 2) at IQVIA Philippines, with extensive experience in project management, people relations, quality management, ethics, and local regulatory policies. She joined IQVIA in 2022 as a Clinical Research Associate (CRA), working on Phase II/III clinical trials in various therapeutic areas. In 2023, she transitioned to a CTE role, expanding her expertise to Rheumatology, Pulmonology, Psychiatry, and Nephrology.
Karen holds a Philippine Pharmacy License, ranking 8th in the National Professional Licensure Examination in April 2021, and is currently pursuing her Juris Doctor Degree, effectively balancing work, school, and personal life. Known for her warm and friendly nature, she excels in building rapport and ensuring studies are conducted to the highest standards of Good Clinical Practices and company procedures.
Overview
4
4
years of professional experience
10
10
years of post-secondary education
4
4
Languages
Work History
Clinical Trial Educator 2
IQVIA RDS Philippines, Inc.
04.2023 - Current
- Clinical Research Professional | Project & Quality Management | Patient Recruitment Strategy
- Spearheaded initiatives to accelerate participant enrollment and enhance site performance in studies with complex protocols and non-traditional patient pathways.
- Successfully streamlined study operations under compressed timelines, ensuring timely diagnosis, enrollment, and protocol adherence through targeted education and continuous site engagement.
- Acted as a primary liaison for clinical sites, collaborating closely with CRAs to provide real-time support, practical guidance, and proactive problem-solving.
- Identified recurring site-level challenges and partnered with sponsors and stakeholders to develop innovative, scalable solutions that improved recruitment and retention outcomes.
- Served as a trusted resource for healthcare professionals, sharing best practices for participant identification, engagement, and long-term retention.
- Navigated competitive recruitment environments by implementing strategic outreach and engagement plans, including mapping referral networks and identifying untapped patient sources.
- Delivered ongoing training and support to site staff and participants on protocol-specific procedures, including drug administration and testing requirements.
- Conducted site assessments and mitigation planning to expand recruitment pipelines, leveraging data-driven mapping of potential referring departments and institutions.
- Led physician outreach and community engagement using IRB-approved materials, including clinic-to-clinic discussions, printed material distribution, and educational sessions.
- Organized awareness-building activities such as lunch-and-learns and community presentations to maintain study visibility and encourage referrals.
- Facilitated in-meeting presentations and provided pre-approved recruitment materials to support groups and community stakeholders, with site consent.
- Maintained and encouraged active engagement of investigators and stakeholders, aligning recruitment goals with broader study milestones to foster long-term support for clinical trials in the region.
Clinical Research Associate
IQVIA RDS Philippines, Inc.
01.2022 - 07.2023
- Clinical Research Associate (CRA 1) | Site Oversight | Regulatory Compliance | Project Coordination
- Conducted all phases of site monitoring visits (selection, initiation, routine, and close-out) in alignment with ICH-GCP guidelines, local regulatory requirements, and study protocols, ensuring high standards of compliance and data integrity.
- Collaborated with investigative sites to develop and track recruitment strategies, improving enrollment predictability and aligning site performance with project timelines.
- Delivered protocol and study-specific training to site staff, fostering strong communication channels and managing expectations to support smooth study execution.
- Assessed site practices for quality and regulatory compliance, escalating issues as needed and contributing to continuous improvement in clinical operations.
- Oversaw study progress by tracking regulatory submissions, patient enrollment, CRF completion, and data query resolution, ensuring timely and accurate data flow.
- Ensured proper documentation and maintenance of Trial Master File (TMF) and Investigator Site File (ISF) in accordance with global and local standards.
- Maintained comprehensive site management documentation, including monitoring visit reports, follow-up letters, and action plans, supporting audit readiness and transparency.
- Collaborated cross-functionally with project teams to support study execution, contributing to risk mitigation, issue resolution, and milestone achievement.
Jr. Clinical Research Associate
Pi Health Inc.
09.2021 - 01.2022
- 1. Supervise site’s procedural and substantive compliance to site independent policies, ethical and local regulatory policies, and International guidelines such as the ICH-GCP in the conduct of study related activities.
- 2. Performs data quality management and review on all relevant data points for all studies assigned to ensure accurate transmission of clinical trial data for analyses
- 3. Perform Source Data Verification;
- 4. Perform effective communication and support in delivering relevant and up-to-date information from all stake holders including sponsor-to-study team, study-team to site-team and vice versa to ensure transparency and oversight on all relevant and timely items in the conduct of clinical trials.
- 5. Collect and authenticate data collection forms (case report forms) and ensure their adherence to the principles of ALCOACCEA and timely submission;
- 6. Monitor progress of and data quality produced by various participating institutions throughout the duration of the trial.
Education
Bachelor of Science - Pharmacy
University of The Philippines
Manila, Philippines 08.2016 - 07.2021
J.D. - Law
University of The Philippines
Quezon City, Philippines 05.2024 - Current
High School - undefined
The Notre Dame of Esperanza, Inc
06.2011 - 03.2015
Skills
Microsoft Word
Interests
Reading, Internet Surfing, Watching Movies, Exploring new developments in the Pharmaceutical World, Singing, Poetry
Trainings and Certifications
- Philippine FDA and SJREB Guidelines V1.0 training
- Central EC/ SJREB Local Guidance Document v2 training 19May2025
- Local Regulations and Requirements in the Philippines_Version 2.0_15Apr2025
- ICH GCP E6 (R3) Understanding the R3
- Service Excellence Foundational Training
- Global Security Awareness: Phishing
- Global Data Privacy
- Good Clinical Practice Fundamentals
- Introduction to Global Pathways (5.0)
- Orientation to using data science-enabled
- Managing Site Noncompliance and Quality Issues
- Reviewing of Informed Consent
- Data Protection and Guidelines
- Risk-Based Management Monitoring Training
- Non-Professional Driver's License, 2024
Awards
Service Award (College), 2021
Academic Awards (College), 2021
Philippine Licensure Examination 8th Place (Pharmacist), 2023
Timeline
J.D. - Law
University of The Philippines
05.2024 - Current
Clinical Trial Educator 2
IQVIA RDS Philippines, Inc.
04.2023 - Current
Clinical Research Associate
IQVIA RDS Philippines, Inc.
01.2022 - 07.2023
Jr. Clinical Research Associate
Pi Health Inc.
09.2021 - 01.2022
Bachelor of Science - Pharmacy
University of The Philippines
08.2016 - 07.2021
High School - undefined
The Notre Dame of Esperanza, Inc
06.2011 - 03.2015
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