Norita Sukri

Phlebotomist

• Collected blood specimens for routine health screenings, ensuring proper patient identification and sample integrity.
• Performed intravenous cannulation within the radiology department and monitored patients for any adverse reactions following medication or IV therapy administration.

• Successfully managed multiple concurrent clinical trials by prioritizing tasks based on urgency, resource allocation, and alignment with organizational objectives.
• Acted as the primary point of contact for sponsors, effectively managing expectations, resolving issues, and ensuring smooth communication throughout the study lifecycle.
• Oversaw all key aspects of clinical study operations including budget management, patient screening and recruitment, and site coordination.
• Developed and maintained comprehensive project plans with defined timelines, milestones, and budget requirements to ensure timely and high-quality project delivery.
• Provided regular and detailed project status updates to stakeholders and executive leadership to support transparency and informed decision-making.
• Built and maintained strong relationships with sponsors, principal investigators, and cross-functional teams, fostering trust and collaboration.
• Reviewed and implemented company Standard Operating Procedures (SOPs), ensuring consistent compliance with GCP and regulatory requirements.
• Accountable for monitoring key study performance indicators (KPIs) and taking proactive corrective actions to mitigate risks.
• Reviewed CRA monitoring reports and supported sponsors in reviewing clinical study reports (CSRs).
• Served as the final gatekeeper of the global Trial Master File (TMF), ensuring completeness, quality, and audit-readiness.
• Provided oversight and quality review across all project activities, ensuring operational excellence and protocol compliance.
• Delivered hands-on guidance and training to project team members and site personnel, and led the onboarding of new employees across multiple project teams.
• Promoted a culture of collaboration by facilitating effective internal communication and ensuring alignment among cross-functional stakeholders.
• Mentored and coached new staff members, contributing to talent development and retention.

• Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines.
• Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and closes clinical trials at investigative sites.
• Oversee multi sites and countries. 15 sites.
• Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely.
• Synthesized and utilized key information from proposals, technical reports and publications to achieve objectives.
• Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
• Provides regular site status information to team members, trial management, and updates trial management tools.
• Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues.
• Performs source document verification and query resolution.
• Ensured timely completion of monitoring visits, enabling consistent oversight of site performance and adherence to Good Clinical Practice guidelines.
• Provided expert guidance to junior team members, fostering a culture of continuous learning and professional growth.
• Mitigated risks to subject safety or study integrity by promptly identifying issues during site visits and implementing corrective actions as necessary.
• Assesses IP accountability, dispensation, and compliance at the investigative sites.
• Reviewing and updating of SOP as per sponsor requirement.
• Facilitates audits and audit resolution.
• Mentors junior level CRAs and serves as a resource for new employees.
• Assigned additional Clinical Operations tasks.
• May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines.
• Developed relationships with key stakeholders, fostering trust and rapport within the network of contacts.
• Developed strong relationships with investigators and site staff, fostering a culture of trust and open communication throughout the study duration.
• Designed effective training materials for site personnel, enhancing understanding of study procedures and expectations.
• Played an instrumental role in driving enrollment success by collaborating closely with sites on recruitment strategies tailored to specific patient populations.
• Optimized study startup times by proactively addressing potential bottlenecks and refining site selection criteria.
• Collaborated with clinical staff and other healthcare professionals to support clinical trial data accuracy.

• Experienced Clinical Research Associate and Project Manager with a strong track record supporting and leading Phase I-IV clinical trials across diverse therapeutic areas including Oncology, Hematology, Neurology, Ophthalmology, Immunology, and Pediatrics.
• Proven ability to manage multi-country trials, monitor sites, oversee cross-functional teams, and maintain sponsor satisfaction through high-quality project delivery and strong relationship management.
• Supported clinical monitoring, project management, and regulatory affairs across all stages of assigned studies.
• Acted as project manager for a regional Phase III oncology study, overseeing all project administration, timelines, and budget tracking.
• Served as the main point of contact for sponsors, proactively managing relationships and resolving project-related issues.
• Led cross-functional teams, coordinated internal communications, and supervised study performance metrics.
• Managed and approved study budgets, ensuring compliance with financial targets and timelines.
• Oversaw trial operations across 10 countries (including Taiwan, Philippines, Malaysia, Singapore, and Thailand) and 11 clinical sites.
• Conducted on-site monitoring visits in Beijing, Malaysia, and Singapore, ensuring GCP compliance and data integrity.
• Performed sponsor quality checks and acted as the final gatekeeper for the global Trial Master File (TMF).
• Reviewed and approved CRA monitoring reports; coordinated and led regular sponsor meetings.
• Mentored and trained new CRAs and project team members, contributing to onboarding and continuous team development.
• Developed detailed project plans with clear milestones and deliverables, driving consistent high-quality outcomes.

• Provided end-to-end research coordination support for clinical trials contracted with IMU, including subject procedures and trial-related activities.
• Oversaw a portfolio of 22 clinical studies: 20 oncology trials and 2 healthy volunteer Phase I studies, ensuring protocol adherence and operational integrity.
• Managed trial logistics, study materials, documentation, and day-to-day administrative operations.
• Participated in Phase I Clinical Operations meetings to contribute to planning and execution strategies.
• Designed training curriculum and delivered hands-on training for junior Clinical Research Coordinators and intern students.
• Developed and revised Standard Operating Procedures (SOPs) for the Phase I unit to align with regulatory and institutional standards.
• Played a key role in audit preparation for both the clinical trial unit and affiliated hospital, resulting in successful audits with no major findings.
• Collaborated closely with sponsors and principal investigators, acting as a relationship manager and key communication point.
• Supported CRA activities by reviewing monitoring reports, resolving site-level issues, and providing feedback on operational challenges.
• Approved study budgets and monitored key performance metrics across studies.
• Provided leadership, quality review, and oversight to project team members and site operations.
• Assisted in the review of Clinical Study Reports (CSRs), ensuring consistency and data accuracy.

• Responsible for project management, administration of clinical trial materials, and performing trial-related duties and/or medical procedures.
• Supervised and mentored junior coordinators and reviewed their work.
• Assisted in audit preparation in clinical trial unit and hospital to ensure compliance.
• Assisted in hosting visitors to relevant department in clinical trial unit.
• Planned trial logistics by liaising with hospital departments for administration and ancillary support.
• Provided in-house training for clinical research coordinators.
• Planned, organized, and coordinated trial workflow.
• Performed internal QA.

• Responsible for administration of clinical trial materials and performing trial-related duties and/or medical procedures.
• Performed venepuncture, port-cath insertion for PK/PD collection.
• Administered oral trial medication.
• Involved in the informed consent process.
• Ensured study compliance.

• Assisted in outpatient clinic and treatment area performing clinical procedures such as infusion administration, IV cannulation, venepuncture, port-cath insertion, pleural tap, and ECG.
• Administered medications via oral, IV, and intramuscular injections and monitored responses.
• Performed routine wound care and dressing changes on schedule.
• Educated patients on disease management, self-care techniques, and wellness strategies to improve long-term health outcomes.
• Maintained up-to-date knowledge on emerging trends in nursing practice to enhance effectiveness in delivering quality care.
• Assisted physicians in performing diagnostic tests and procedures to facilitate prompt diagnosis and treatment.
• Educated family members and caregivers on patient care instructions.
• Implemented care plans for patient treatment after assessing physician medical regimens.

• Performed bedside nursing care and other clinical nursing procedures.
• Improved patient outcomes by implementing evidence-based care practices and clinical guidelines.
• Developed comprehensive care plans for patients, resulting in enhanced health management.
• Used first-hand knowledge and clinical expertise to advocate for patients under care and enacted prescribed treatment strategies.
• Administered medications via oral, IV, and intramuscular injections and monitored responses.
• Monitored patient reactions after administering medications and IV therapies.
• Performed triage on incoming patients and determined severity of injuries and illnesses.
• Observed and documented patient factors such as diets, physical activity levels and behaviors to understand conditions and effectively modify treatment plans.
• Collected blood, tissue, and other laboratory specimens and prepared for lab testing.
• Equipped patients with tools and knowledge needed for speedy and sustained recovery.
• Organized and detail-oriented with a strong work ethic.
• Monitored patient condition by interpreting and tracking EKG readings, identifying irregular telemetry readings and updating team members on changes in stability or acuity.
• Maintained quality care and comfort for patients with heart failure, pulmonary hypertension, and other conditions.
• Performed accurate documentation of patient assessments, interventions, and outcomes in compliance with regulatory standards.