Summary
Overview
Work History
Education
Skills
Accomplishments
Skills Highlights
Other Professional Experience
Core Qualifications - Certifications
Timeline
Generic
JOHNNA TURDANES - ALARVA

JOHNNA TURDANES - ALARVA

Pasig

Summary

Clinical Research QC Team Supervisor with a proven track record at Alliance Clinical Network, showcasing expertise in regulatory compliance (GCP, ICH Guidelines) and team leadership. Excelled in enhancing data quality assurance and streamlining processes, achieving a significant improvement in project timelines. Skilled in cross-functional collaboration and strategic planning, adept in Microsoft Office Suite. Seasoned Product Trainer with background in developing and delivering comprehensive product training programs. Strengths lie in ability to create engaging content, facilitate interactive sessions, and provide ongoing coaching for continuous improvement. Previously improved product understanding among teams leading to increased customer satisfaction and sales growth.

Overview

13
13
years of professional experience

Work History

Clinical Research QC Team Supervisor

Alliance Clinical Network
02.2023 - 12.2024
  • Supervise, mentor, and manage the daily activities of the QC team
  • Provide training and guidance to QC staff on quality standards, processes, and compliance requirements
  • Evaluate team performance and provide feedback for professional growth
  • Manage workload distribution and ensure timely completion of QC activities
  • Oversee the review of clinical trial documents, including Case Report Forms (CRFs), Trial Master Files (TMFs), and study protocols, for accuracy, completeness, and compliance
  • Ensure that clinical research data is accurate and aligns with study objectives and regulatory requirements
  • Conduct periodic audits or spot checks of data, reports, and processes to ensure adherence to quality standards
  • Identify trends in quality issues and implement corrective and preventive actions (CAPA)
  • Ensure all QC activities comply with GCP, ICH guidelines, FDA, EMA, and other applicable regulations
  • Maintain an in-depth understanding of clinical research standards and guidelines to ensure compliance
  • Prepare for and support internal and external audits or inspections by regulatory authorities and sponsors
  • Oversee the maintenance and management of QC reports, logs, and documentation
  • Compile and review QC metrics and performance reports for senior management
  • Ensure timely resolution and documentation of quality issues or discrepancies
  • Analyze QC processes and recommend improvements to enhance efficiency and effectiveness
  • Collaborate with cross-functional teams to develop and implement updated SOPs and workflows
  • Stay informed on industry best practices and integrate them into QC activities
  • Act as the primary point of contact for QC-related matters within the organization
  • Work closely with clinical operations, data management, and regulatory teams to align on quality expectations and deliverables
  • Provide updates to senior leadership on QC activities, findings, and resolutions

Clinical Research Associate IV

Excel Clinical Research
07.2022 - 02.2023
  • Conduct and oversee all types of site visits (pre-study, initiation, interim monitoring, and close-out)
  • Ensure compliance with study protocols, Good Clinical Practice (GCP), International Council for Harmonisation (ICH) guidelines, and applicable regulations
  • Verify the accuracy and completeness of case report forms (CRFs) or electronic data capture (EDC) systems
  • Monitor site performance metrics, ensuring proper enrollment, data quality, and adherence to timelines
  • Build and maintain strong relationships with investigators, site staff, and other stakeholders
  • Provide guidance and training to site personnel on study protocols, investigational products, and regulatory compliance
  • Identify and address site-specific challenges, escalating critical issues when necessary
  • Proactively identify and mitigate risks to study timelines, quality, and compliance
  • Conduct root cause analyses for protocol deviations, data discrepancies, or non-compliance issues
  • Ensure proper reporting and documentation of adverse events (AEs) and serious adverse events (SAEs)
  • Review and ensure completeness and accuracy of trial master files (TMF), site master files (SMF), and other regulatory documents
  • Collaborate with the data management team to resolve queries and discrepancies
  • Ensure timely submission of monitoring reports, site correspondence, and follow-up letters
  • Provide training, mentoring, and guidance to junior CRAs and study coordinators
  • Share best practices and support the development of standard operating procedures (SOPs)
  • Act as a subject matter expert (SME) for complex study
  • Collaborate with sponsors, project managers, regulatory teams, and site personnel to ensure the smooth execution of studies
  • Provide regular updates on site performance, study progress, and potential challenges to stakeholders
  • Support audits and inspections by regulatory authorities or sponsors

Study Start-Up & Regulatory Specialist

Excel Clinical Research
03.2020 - 07.2022
  • Assist in initiating clinical studies, including preparing and submitting regulatory and ethics committee documents
  • Support site feasibility assessments and site initiation processes
  • Ensure all required approvals are obtained before study initiation
  • Compile, review, and submit essential regulatory documents, including investigator brochures, protocols, informed consent forms, and clinical trial applications
  • Maintain compliance with local, regional, and international regulatory requirements
  • Track, organize, and maintain study-related documents, including regulatory and ethics submissions, approvals, and correspondence
  • Update regulatory trackers and maintain study-specific filing systems
  • Serve as a liaison between the onshore study team, sponsors, and regulatory authorities
  • Coordinate with stakeholders to resolve issues related to regulatory submissions and study approvals
  • Identify areas for efficiency in the regulatory and start-up process
  • Implement best practices to streamline study initiation timelines
  • Provide guidance on regulatory requirements and study start-up processes to internal teams or external stakeholders as needed
  • Stay up-to-date on changes in regulatory guidelines and share updates with relevant teams

Clinical Research Coordinator

Healthserv Medical Center
Laguna Site
08.2011 - 09.2019
  • Set up and maintain research sites, including procurement of necessary supplies and equipment
  • Assist in obtaining Institutional Review Board (IRB) approvals and maintain compliance with Good Clinical Practice (GCP) guidelines and FDA regulations
  • Identify, recruit, and screen eligible participants according to the study inclusion/exclusion criteria
  • Educate participants about the study objectives, procedures, risks, and benefits, obtaining informed consent
  • Track participants' progress, including scheduling visits, collecting data, and managing follow-ups
  • Record accurate data into Case Report Forms (CRFs) or electronic databases
  • Oversee collection, processing, and shipment of biological samples, if required
  • Maintain thorough and up-to-date records, including source documents, deviations, and adverse event reports
  • Work with investigators, sponsors, monitors, and other stakeholders to ensure smooth study operations
  • Ensure readiness for audits by maintaining complete and accurate documentation
  • Monitor and report adverse events, protocol deviations, and non-compliance issues to the sponsor or IRB
  • Stay updated on clinical trial regulations and attend training sessions as required

Part-Time Medical Assistant/Secretary

Healthserv Medical Center
Los Banos
  • Take vital signs
  • Collect information about conditions and treatment plans from nurses and doctors
  • Prepare utensils or other medical apparatus, medicines and disinfectant needed for some procedures
  • Data management

Customer Service Representative

Sykes Asia
Makati
  • Customer service representatives interact with customers on behalf of an organization
  • They provide information about products and services, take orders, respond to customer complaints, and process returns
  • Maintaining a positive, empathetic, and professional attitude toward customers at all times
  • Responding promptly to customer inquiries
  • Communicating with customers through various channels
  • Acknowledging and resolving customer complaints
  • Knowing our products inside and out so that you can answer questions
  • Processing orders, forms, applications, and requests
  • Keeping records of customer interactions, transactions, comments, and complaints
  • Communicating and coordinating with colleagues as necessary
  • Providing feedback on the efficiency of the customer service process
  • Managing a team of junior customer service representatives
  • Ensure customer satisfaction and provide professional customer support

Education

Diplomate in Practical Nursing - NC II Certificate

Beatitudes Technological and Theological College Foundation
Cavite
01.2016

Diplomate in Computer Science -

Informatics
Los Banos, Laguna
01.2001

B.S. - Biology

Far Eastern University
Manila
01.1997

Skills

  • Clinical Research Operations Management
  • Regulatory Compliance (GCP, ICH Guidelines)
  • Team Leadership and Coordination
  • Data Quality Assurance
  • Strategic Planning and Resource Allocation
  • Cross-Functional Collaboration
  • Problem-Solving and Process Optimization
  • Clinical Trial Management Systems (CTMS)
  • Electronic Data Capture (EDC) Platforms
  • Clinical Research IO (CRIO)
  • Project Management Tools (eg, MS Project, Jira)
  • Microsoft Office Suite
  • Microsoft 365
  • Ringaro
  • Firecrest
  • SnapClinical Manager
  • Veeva Vault
  • Exostar
  • TrialManager
  • Science 37 University
  • Medication administration
  • Documentation and charting
  • Monitor clinical trial progress through a data review (eCRF and Source Documents)
  • Computer Literate
  • Advanced Communication Skills (Tagalog, and English)

Accomplishments

  • Successfully led offshore teams to complete [specific projects/clinical studies] on time and within budget.
  • Reduced operational discrepancies by [98%] through process improvements and team training.
  • Enhanced collaboration between onshore and offshore teams, resulting in improved project efficiency and communication.

Skills Highlights

  • Medication administration
  • Documentation and charting
  • Monitor clinical trial progress through a data review (eCRF and Source Documents)
  • Computer Literate
  • Advanced Communication Skills (Tagalog, and English)

Other Professional Experience

  • Part-Time Medical Assistant/Secretary, 3 years, Healthserv Medical Center, Los Banos, Laguna, Philippines, Take vital signs, Collect information about conditions and treatment plans from nurses and doctors, Prepare utensils or other medical apparatus, medicines and disinfectant needed for some procedures., Data management
  • Customer Service Representative, 2 years & 9 months, Sykes Asia, Makati, Philippines, Customer service representatives interact with customers on behalf of an organization. They provide information about products and services, take orders, respond to customer complaints, and process returns., Maintaining a positive, empathetic, and professional attitude toward customers at all times., Responding promptly to customer inquiries., Communicating with customers through various channels., Acknowledging and resolving customer complaints., Knowing our products inside and out so that you can answer questions., Processing orders, forms, applications, and requests., Keeping records of customer interactions, transactions, comments, and complaints., Communicating and coordinating with colleagues as necessary., Providing feedback on the efficiency of the customer service process., Managing a team of junior customer service representatives., Ensure customer satisfaction and provide professional customer support.

Core Qualifications - Certifications

  • Good Clinical Practice (NIDA Clinical Trial Network)
  • Good Clinical Procedure Workshop and Training (PCRP)
  • DataLabs EDC eLearning Certificate
  • Clinical Research IO Training Certificate
  • Protocol Training Certificates for 48 studies
  • Veeva Learning Certificate
  • Science 37 University Training
  • Healthcare Services NC II
  • First Aid
  • BLS Certified
  • Metro Private Line LBW Training (Sykes Asia)
  • English Proficiency (Sykes Asia)

Timeline

Clinical Research QC Team Supervisor

Alliance Clinical Network
02.2023 - 12.2024

Clinical Research Associate IV

Excel Clinical Research
07.2022 - 02.2023

Study Start-Up & Regulatory Specialist

Excel Clinical Research
03.2020 - 07.2022

Clinical Research Coordinator

Healthserv Medical Center
08.2011 - 09.2019

Part-Time Medical Assistant/Secretary

Healthserv Medical Center

Customer Service Representative

Sykes Asia

Diplomate in Practical Nursing - NC II Certificate

Beatitudes Technological and Theological College Foundation

Diplomate in Computer Science -

Informatics

B.S. - Biology

Far Eastern University

Similar Profiles

CREATE PROFILE
JOHNNA TURDANES - ALARVA