Summary
Overview
Work History
Education
Skills
Personal Information
Accomplishments
Additional Information
References
Timeline
Generic

Hooi Peng Khoo

Bayan Lepas,Penang

Summary

Dynamic Senior Clinical Research Associate with extensive experience, adept at clinical trial management and regulatory compliance. Proven track record in enhancing patient recruitment strategies and ensuring adherence to ICH-GCP guidelines. Strong leadership and problem-solving skills foster collaboration and drive successful project outcomes. Skilled clinical research coordinator with background in managing and overseeing clinical trials. Experience includes coordinating with research teams, ensuring compliance with protocols, and managing participant recruitment and data collection processes. Possess strong organizational skills, ability to manage multiple tasks efficiently, and capability to ensure accuracy in documentation and reporting. Contributed to improving trial procedures and enhancing data integrity in previous roles.

Overview

17
17
years of professional experience

Work History

Senior Clinical Research Associate

ICON Plc
07.2024 - Current
  • Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
  • Managed project risk by identifying, quantifying and monitoring potential threats.
  • Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
  • Followed drug storage procedures to comply with protocols and SOP requirements.
  • Conducted independent research to validate efficacy of solutions, assimilate results and prepare written technical reports.
  • Maintained knowledge of company strategic direction, goals and objectives and aligned projects appropriately.
  • Implemented electronic data capturing systems to adhere with clinical research guidelines.
  • Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
  • Guided development of adaptive systems framework that integrated data from multiple sources to augment training and operational performance.
  • Generated and upload assay data and communicated results and reports to multi-disciplinary project teams to influence progression in discovery and development.
  • Directed, guided and delegated tasks to teams and developed project schedules, resource requirements and timelines to maintain productivity on goals and objectives.
  • Managed multiple studies in compliance with ICH-GCP, local regulations, and SOPs.
  • Conducted site visits (initiation, monitoring, close-out) and ensured regulatory compliance.
  • Supervised site personnel on trial deliverables, subject enrollment, and data submission.
  • Led risk assessments and escalated site deficiencies, ensuring timely corrective actions.
  • Supported audit preparation and follow-up to maintain trial quality and compliance.
  • Enhanced patient safety through meticulous monitoring of adverse events and protocol compliance.
  • Facilitated focus group sessions with project patients.
  • Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
  • Played an instrumental role in driving enrollment success by collaborating closely with sites on recruitment strategies tailored to specific patient populations.
  • Reduced study timelines by effectively managing multiple concurrent clinical trials across various therapeutic areas.
  • Demonstrated thorough knowledge of regulatory requirements in all aspects of clinical trial conduct, promoting compliance within assigned projects.
  • Ensured timely completion of monitoring visits, enabling consistent oversight of site performance and adherence to Good Clinical Practice guidelines.
  • Strengthened collaboration with cross-functional teams, ensuring clear communication and alignment on project goals.
  • Synthesized and utilized key information from proposals, technical reports and publications to achieve objectives.
  • Mentored and guided junior Clinical Research Associates (CRAs) by providing training, on-site support, and performance feedback, fostering professional development, and ensuring high-quality trial conduct.
  • Manage and conduct feasibility.

Senior Clinical Research Associate

IQVIA
03.2024 - 07.2024
  • Organized and maintained research study regulatory documents in site binder to maintain accuracy and integrity.
  • Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
  • Followed drug storage procedures to comply with protocols and SOP requirements.
  • Conducted independent research to validate efficacy of solutions, assimilate results and prepare written technical reports.
  • Maintained knowledge of company strategic direction, goals and objectives and aligned projects appropriately.
  • Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
  • Synthesized and utilized key information from proposals, technical reports and publications to achieve objectives.
  • Guided development of adaptive systems framework that integrated data from multiple sources to augment training and operational performance.
  • Generated and upload assay data and communicated results and reports to multi-disciplinary project teams to influence progression in discovery and development.
  • Directed, guided and delegated tasks to teams and developed project schedules, resource requirements and timelines to maintain productivity on goals and objectives.
  • Managed project risk by identifying, quantifying and monitoring potential threats.
  • Designed and executed studies to support usability of solutions, analyze data and provide actionable recommendations to project team.
  • Enhanced patient safety through meticulous monitoring of adverse events and protocol compliance.
  • Supported regulatory submissions with comprehensive documentation preparation, leading to successful approval of investigational products.
  • Increased the accuracy of study data by implementing robust quality control measures during data review and analysis phases.
  • Strengthened collaboration with cross-functional teams, ensuring clear communication and alignment on project goals.
  • Mitigated risks to subject safety or study integrity by promptly identifying issues during site visits and implementing corrective actions as necessary.
  • Provided expert guidance to junior team members, fostering a culture of continuous learning and professional growth.
  • Streamlined vendor management processes for more efficient service delivery in support of clinical trial activities.
  • Ensured timely completion of monitoring visits, enabling consistent oversight of site performance and adherence to Good Clinical Practice guidelines.
  • Assisted in budget planning and forecasting for clinical research projects, optimizing resource allocation while maintaining high-quality standards.
  • Reduced study timelines by effectively managing multiple concurrent clinical trials across various therapeutic areas.
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
  • Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.
  • Prepared and maintained regulatory documents for clinical trial submissions.
  • Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
  • Monitored unit budget to meet financial objectives for spend rate and funding.
  • Complied with research protocols by providing ongoing quality control audits.
  • Performed on-site monitoring and managed study timelines for multiple clinical sites.
  • Collaborated with study teams on subject recruitment plans and regulatory submissions.
  • Administered protocol training to site teams, ensuring adherence to study protocols.
  • Managed ISF and TMF documentation in accordance with local and global regulations.

Clinical Research Associate 2

IQVIA
11.2022 - 03.2024
  • Conducted clinical trial in accordance with protocol and recorded and monitored progress.
  • Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
  • Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
  • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
  • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
  • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
  • Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements.
  • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.
  • Collaborate and liaise with study team members for project execution support as appropriate.
  • Ensured protocol adherence, conducting regular site visits and providing training to study staff as needed.
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
  • Regulatory and Ethics submission.
  • Developed strong relationships with investigators and site personnel to ensure ongoing compliance with study requirements.
  • Assessed safety reporting requirements for each study, ensuring proper documentation and notification procedures were followed consistently.
  • Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits to maintain and enforce regulatory compliance.
  • Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.
  • Assisted in investigator selection and qualification process to provide capable investigators with adequate resources to properly conduct trials.
  • Conducted thorough site feasibility assessments for potential clinical trial participation, identifying suitable sites for studies.
  • Liaised with clinical investigator to identify, assess and resolve site performance, quality and compliance issues.
  • Mentored team members by sharing suggestions and encouraging ideas to deliver successful studies.
  • Monitored unit budget to meet financial objectives for spend rate and funding.

Clinical Research Associate

Paraxel
07.2021 - 11.2022
  • Conducted clinical trial in accordance with protocol and recorded and monitored progress.
  • Study start up activities.
  • Manage country specific feasibility and/or site pre-qualification and qualification Activities.
  • Preparation, negotiation, and facilitation of execution of Confidentiality.
  • Agreements (CDA), Clinical Site Agreements (CSAs) and any amendments.
  • Develop strategy to configure, distribute, and collect, and review and approve, high quality country specific and/or site-specific documents or essential regulatory documents (SRP) and any updated or amended regulatory documentation.
  • Customize, review, and negotiate as needed, country/site specific.
  • Informed Consent Forms (ICF), translations (within parameters of country/regulatory/client requirements), and customize and negotiate any amendments.
  • Prepare and submit IRB/IEC and MoH/RA (if applicable) application(s), resolving conflicts, determining appropriate follow up until receipt of final approval.
  • Update and maintain appropriate Clinical Trial Management systems (CTMS) in a timely manner.
  • Promptly identify, use judgment and knowledge to address and resolve or escalate, any site question and/or issue, including but not limited to: potential issues or risks with site activation timelines, issues with patient recruitment strategy, deficiencies in training, data quality or integrity, study non- compliance.
  • Facilitate and support allocated sites with access to relevant study systems and ensure compliant with all projects specific training requirements prior to study start.Act as PAREXEL’s direct contact with assigned sites, assess and ensure overall integrity of study implementation and adherence to study protocol at clinical sites and perform problem-solving to address and resolve site issues.
  • Evaluate site recruitment plan in collaboration with the site staff on an ongoing basis and provide strategy for improvements.
  • Perform on-site visits; this includes Qualification and Initiation visits; apply judgment and knowledge to independently resolve site issues, questions and concerns.
  • Generate visit/contact report.
  • Evaluate overall compliance and performance of sites and site staff: provide recommendations regarding site-specific actions and use judgment and experience to assess the ability and motivation of site staff.
  • Assess & manage test article/study supply including supply, accountability and destruction/return status.
  • Review & follow-up site payment status.
  • Follow-up on CRF data entry, query status, and SAEs.
  • Conduct on-site study-specific training (if applicable).
  • Perform site facilities assessments.
  • Recognize impact of study non-compliance/issues/delays/changes on study timelines and communicate study issues that require immediate action, with proposed strategy for resolution.

Study Coordinator Level 2

Clinical Research Malaysia
04.2020 - 07.2021
  • Streamlined communication between participants and research team, fostering effective collaboration and data collection.
  • Contributed to a positive work environment by fostering open communication, teamwork, and professional development opportunities for staff members.
  • Expedited study start-up timelines by efficiently coordinating site initiation visits, trainings, and equipment setup.
  • Contributed to successful grant applications by assisting with proposal preparation, submission, and follow-up activities.
  • Improved data accuracy by implementing rigorous quality control measures during data collection and entry processes.
  • Assisted investigators with publication efforts by contributing to manuscript development, editing, and submission processes.
  • Ensured regulatory compliance by meticulously maintaining documentation for study activities.
  • Enhanced interdisciplinary collaboration among researchers by organizing regular team meetings and progress updates.
  • Provided comprehensive training to new staff members, ensuring seamless integration into existing workflows while maintaining high-quality work standards.
  • Maintained up-to-date knowledge of industry best practices, regulations, and advancements in clinical research coordination methodologies.
  • Strengthened relationships with external partners such as clinical sites and vendors through effective communication channels and consistent follow-through on commitments.
  • Supported participant retention efforts by designing engaging materials that highlighted the benefits of continued involvement in the study.
  • Enhanced patient satisfaction by efficiently coordinating and managing study schedules.
  • Promoted a culture of continuous improvement within the research team through constructive feedback on study processes and outcomes.
  • Collected data and followed research protocols, operations manuals, and case report form requirements.
  • Facilitated timely enrollment of participants through targeted recruitment strategies.
  • Worked with principal investigator and sponsors to facilitate daily trial activities and comply with research protocols.
  • Monitored patient safety throughout clinical trials and reported any adverse events.
  • Maintained compliance with protocols covering patient care and clinical trial operations.
  • Managed patient recruitment, informed consent process and data entry to support trial objectives.
  • Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
  • Developed and maintained accurate and up-to-date case report forms and source documents.
  • Participated in initiation visits and investigator meetings, implementing trials following study timelines and budgets.
  • Gathered, processed, and shipped lab specimens.
  • Prepared and maintained regulatory documents for clinical trial submissions.
  • Followed clinical research protocols and conducted study visits in compliance with ICH/GCP and FDA regulations.
  • Coordinated and monitored clinical trial activities to support timely and accurate completion of studies.
  • Complied with research protocols by providing ongoing quality control audits.
  • Collected, evaluated, and modeled collected data.
  • Facilitated focus group sessions with project patients.
  • Monitored unit budget to meet financial objectives for spend rate and funding.

Research Nurse and Sr Clinical Study Coordinator

Infokinetics Research Centre
05.2014 - 04.2020
  • Lead junior research coordinator, fostering professional growth and collaborative work environments.
  • Played a key role in improving patient outcomes by identifying areas for improvement in clinical care through ongoing monitoring and evaluation of research findings.
  • Contributed to the advancement of medical knowledge by presenting research findings at national conferences and publishing in peer-reviewed journals.
  • Optimized patient recruitment efforts through targeted outreach strategies and clear communication of study objectives.
  • Assisted with the development of policies and procedures for research nursing practice to ensure consistency across studies and compliance with regulatory guidelines.
  • Strengthened partnerships with community organizations that led to enhanced recruitment strategies and increased study enrollment.
  • Evaluated emerging trends in nursing practice by participating in continuing education courses, webinars, workshops, seminars or conferences related to research nursing field.
  • Ensured patient safety and adherence to ethical standards by carefully monitoring study procedures and reporting any deviations.
  • Established strong working relationships with patients, families, and healthcare providers to facilitate seamless coordination of care throughout the research process.
  • Maintained extensive documentation of patient progress, treatment plans, and adverse reactions to ensure complete records for future reference and regulatory compliance.
  • Minimized risk of bias in study outcomes by rigorously adhering to randomization procedures during participant enrollment processes.
  • Reduced protocol deviations by providing thorough training on study procedures to both staff members and participants alike.
  • Enhanced clinical trial efficiency through meticulous data collection and analysis, ensuring accurate results.
  • Developed research protocols in collaboration with multidisciplinary teams for streamlined study execution.
  • Improved patient care by conducting comprehensive health assessments and implementing individualized nursing interventions.
  • Documented treatments delivered, medications and IVs administered, discharge instructions, and follow-up care.
  • Evaluated patient histories, complaints, and current symptoms.
  • Monitored patient reactions after administering medications and IV therapies.
  • Communicated with healthcare team members to plan, implement and enhance treatment strategies.
  • Educated family members and caregivers on patient care instructions.
  • Provided skilled, timely and level-headed emergency response to critically-ill patients.
  • Supported interdisciplinary collaborations through effective communication between researchers, physicians, pharmacists, and other healthcare professionals involved in the studies.
  • Increased patient retention rates within longitudinal studies through consistent engagement efforts such as regular phone calls or check-ins to address concerns or questions about the research process.
  • Streamlined data collection processes by implementing electronic health record systems, resulting in more accurate and efficient data analysis.
  • Recorded details regarding therapies to keep patient charts updated.
  • Quickly responded to situations impacting safety and security to unit, actualizing crisis prevention interventions to control and de-escalate situations.
  • Observed and documented patient factors such as diets, physical activity levels, and behaviors to understand conditions and effectively modify treatment plans.
  • Led teams in driving successful patient outcomes by prioritizing standard of care and best practices.
  • Conducted ongoing monitoring and evaluations of behaviors and conditions, and updated clinical supervisors with current information.
  • Performed frequent checks on life support equipment and made necessary adjustments to preserve optimal patient conditions.
  • Investigated and resolved issues affecting hospital operations and patient care.
  • Leveraged feedback and process improvement opportunities to create safer and healthier environment and increase patient satisfaction.
  • Reported findings to quality departments after conducting routine restraint audits and worked with team to devise corrective actions for deficiencies.
  • Worked with healthcare team to develop new dialysis treatment flow sheet and other log forms, improving clinical documentation and accountability.
  • Development and/or evaluation of protocol and case report form for BA/BE studies.
  • Processing Submission to the ethics committees and regulatory bodies and communicating with relevant authorities for approval.
  • Development, translation and/or evaluation of subject information sheet, subject’s diary and other recruitment materials.
  • Develop and maintain study documents (Master file, CRFs).
  • Prescreening and recruitment for new volunteers and retention of current volunteers.
  • Coordinate application for regulatory approvals for importation of IP.
  • Remote monitoring (SDR/SDV), provide support to Sister Company (Borneo Kinetic, Sarawak) in the conduct of BE studies, maintain Master file as accordance to GCP.
  • Planning, task allocating and rostering for doctors, nurses, and study coordinators as according to the protocol requirement.
  • Provide training (e.g., SIV, blood taking procedure, safety monitor) to all Investigators, study nurse and clinical laboratory assistant.
  • Assess new potential Study coordinator prior job offer and involvement in interviewing new candidate.
  • Train new permanent study coordinator, assistant study coordinator and research nurse accordance to job description and task.

Senior State Registered Nurse

Hospital Lam Wah Ee Penang
07.2008 - 07.2013
  • Administered medications safely according to established guidelines while closely monitoring for side effects or adverse reactions requiring intervention.
  • Prevented the spread of infections by consistently adhering to strict infection control protocols and educating patients on proper hygiene practices.
  • Utilized critical thinking skills to prioritize nursing interventions based on patients'' acuity levels and individual needs.
  • Enhanced patient satisfaction by providing compassionate, holistic nursing care that addressed physical, emotional, and spiritual needs.
  • Assisted in the training and mentorship of new nursing staff members, contributing to a positive work environment and high-quality patient care.
  • Provided support for patients'' families during difficult medical decisions or end-of-life care, serving as a liaison between the healthcare team and loved ones.
  • Collaborated with interdisciplinary teams to develop comprehensive treatment plans for complex patients with multiple comorbidities.
  • Conducted thorough patient assessments to identify changes in condition, promptly notifying physicians and initiating appropriate interventions when necessary.
  • Improved patient outcomes by implementing evidence-based nursing interventions and individualized care plans.
  • Advised patients and caregivers of proper wound management, discharge plan objectives, safe medication use, and disease management.
  • Contributed to interdisciplinary team meetings by presenting relevant clinical data about patients'' progress toward reaching established goals of care.
  • Skillfully managed challenging patient situations using de-escalation techniques, crisis intervention strategies, and therapeutic communication skills.
  • Participated in ongoing professional development opportunities to stay current on best practices in nursing care and emerging trends in healthcare delivery.
  • Implemented evidence-based fall prevention strategies, resulting in a significant decrease in patient falls within the unit.
  • Served as a preceptor for nursing students during their clinical rotations, providing valuable real-world experience and guidance to foster professional growth.
  • Streamlined medication administration processes for increased safety and accuracy during busy shifts.
  • Facilitated patient transitions between different levels of care, ensuring continuity of services and minimizing disruptions in treatment plans.
  • Promoted a culture of safety within the healthcare facility by participating in quality improvement initiatives, identifying potential hazards, and advocating for best practices in nursing care delivery.
  • Managed patients recovering from medical or surgical procedures.
  • Offered exceptional care and support to individuals recovering from acute incidents and dealing with chronic conditions.
  • Led teams in driving successful patient outcomes by prioritizing standard of care and best practices.

Education

Bachelor of Science - Nursing Science

Open University Malaysia
Malaysia
09-2025

High School Diploma -

Lam Wah Ee Nursing College
Malaysia
07.2008

Skills

    Vendor management

    Resource management

    Time management

    Good clinical practices

    Site monitoring

    ICH-GCP compliance

    Investigator relations

    Regulatory knowledge

    Organizational skills

    Quality assurance

Personal Information

Title: Senior Clinical Research Associate

Accomplishments

  • Demonstrated leadership and commitment, motivating site staff and keeping teams engaged, resulting in key achievements, such as screening and randomizing subjects soon after site activation (ARTEMIDE-01 Study).
  • Recognized by Global Study Associate Director for dedication and hard work in meeting challenging submission deadlines for DESTINY LUNG-03.
  • Successfully cleared backlogs at two new sites in under two months for the SERENA-4 study, achieving the IDMC deadline while developing a strong connection with the site coordinator, leading to improved site efficiency.
  • Identified significant gaps in ECG report uploads missed by the study team since 2021, helping improve data accuracy.
  • Consistently maintained clean data with no pending queries after taking over the LAURA study.
  • Involved from SQV stage in the ARTEMIDE-01 study, showing proactive efforts to accelerate submission processes and effectively managing site queries.

Additional Information

Accomplishment:

• Demonstrated leadership and commitment, motivating site staff and keeping teams engaged, resulting in key achievements, such as screening and randomizing subjects soon after site activation (ARTEMIDE-01 Study).
• Recognized by Global Study Associate Director or dedication and hard work in meeting challenging submission deadlines for DESTINY
LUNG-03.
• Successfully cleared backlogs at two new sites in under two months for the SERENA-4 study, achieving the IDMC deadline while developing a
strong connection with the site coordinator, leading to improved site efficiency.
• Identified significant gaps in ECG report uploads missed by the study team since 2021, helping improve data accuracy.
• Consistently maintained clean data with no pending queries after taking over the LAURA study.
• Involved from SQV stage in the ARTEMIDE-01 study, showing proactive efforts to accelerate submission processes and effectively managing
site queries.
• Awarded a spot award bonus for outstanding contributions to the Pfizer Oral COVID treatment program, working at "lightspeed" to meet tight
timelines and ensure life-saving treatments were delivered to patients quickly.
• Received recognition from Pfizer Lightspeed program team for exceptional teamwork and collaboration, helping expedite approval and
site activation timelines for C467 oral antiviral studies.
• Praised for willingness to take on new challenges and learn quickly, contributing effectively to team success and study progress.
• Managed the study start-up process from submission to site activation within 2 months, ensuring streamlined approvals and timely activation for multiple sites.
• Actively involved in internal audits with no major findings for a major pharmaceutical company, showcasing strong adherence to compliance
and regulatory standards.
• Successfully participated in external inspections, including audits from local Ethics Committee (JPEC - Joint Penang Ethics Committee), FDA inspections, and sponsor audits, ensuring site readiness and compliance throughout the study lifecycle.

References

References available upon request.

Timeline

Senior Clinical Research Associate

ICON Plc
07.2024 - Current

Senior Clinical Research Associate

IQVIA
03.2024 - 07.2024

Clinical Research Associate 2

IQVIA
11.2022 - 03.2024

Clinical Research Associate

Paraxel
07.2021 - 11.2022

Study Coordinator Level 2

Clinical Research Malaysia
04.2020 - 07.2021

Research Nurse and Sr Clinical Study Coordinator

Infokinetics Research Centre
05.2014 - 04.2020

Senior State Registered Nurse

Hospital Lam Wah Ee Penang
07.2008 - 07.2013

Bachelor of Science - Nursing Science

Open University Malaysia

High School Diploma -

Lam Wah Ee Nursing College

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Hooi Peng Khoo