Norita Sukri
Singapore
Summary
Senior Research Associate specializes in establishing project objectives, developing experimental plan and effectively prioritizing tasks to meet time sensitive delivery goals. Displays strong written and oral communication skills to present complex analyses effectively. . Uses analytical skills to identify data or patient safety issues. To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills. Detail-oriented Clinical Research Associate well-versed in coordinating operations, managing sites and drafting detailed clinical reports. Knowledgeable about action planning, database locking and standard operating procedures. Supports participant recruitment and management to meet research objectives.
Overview
36
36
years of professional experience
1
1
Certification
Work History
Senior Clinical Research Associate
PRA Health Sciences
02.2019 - Current
- 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
- Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely
- 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 essential document site file reconciliation
- Performs source document verification and query resolution
- 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.
- Streamlined vendor management processes for more efficient service delivery in support of clinical trial activities.
Senior Clinical Research Associate
CMIC Asia-Pacific Pte Ltd
11.2016 - 01.2019
- Conducts qualification, initiation, interim, and closeout monitoring visits
- Manages full site management, ensuring adherence to protocol, accurate data collection, and investigational product/biological samples/supplies accountability
- Facilitates regulatory authority clinical trial applications/notifications and completes query reconciliation
- Trains site staff on EDC system, protocol, and GCP guidelines
- Manages a variety of study aspects including budget oversight and patient screening and recruitment
- Reviews and negotiates site budget on behalf of sponsor
- Acts as the main point of contact to sponsor, mitigating and resolving issues arising from sponsor requests
- Serves as the primary coordinator for all communication within the project team
- Manages internal project team members
- Manages and approves study budgets
- Responsible for key study performance indicators
- Acts as project manager for one phase one oncology study, handling all aspects of project administration and finance tracking tasks
- Coordinates and attends routine sponsor meetings
- Trains and orients new staff into the study
- Acts as the final gatekeeper for the global trial master file of the study
- Responsible as the 'relationship manager' of the sponsor
- Assists sponsor in reviewing the clinical study report
- Reviews CRA's monitoring report
- Builds good relationships with sponsor and principal investigator
- Provides supervision, quality review, and oversight management
- Provides guidance and training to project team and site personnel
- Approves corporate expenses
- Mentors and trains new employees within the company and supports onboarding of new members to the various project teams.
Project Manager
CMIC Asia-Pacific Pte Ltd
06.2015 - 01.2019
- Supported project management, clinical monitoring, and/or regulatory affairs operations in all aspects of assigned projects
- Supported study start-up activities
- Acted as project manager for one regional phase III oncology study, handling all aspects of project administration and finance tracking tasks
- Acted as the main point of contact to sponsor, mitigating and resolving issues arising from sponsor requests
- Served as the primary coordinator for all communication within the project team
- Managed internal project team members
- Managed and approved study budgets
- Responsible for key study performance indicators
- Reviewed and approved monitoring reports as project manager
- Coordinated and attended routine sponsor meetings
- Trained and oriented new staff into the study
- Acted as the final gatekeeper for the global trial master file of the study
- Responsible as the 'relationship manager' of the sponsor
- Provided supervision, quality review, and oversight management
- Provided guidance and training to project team and site personnel
- Approved corporate expenses
- Mentored and trained new employees within the company and supported onboarding of new members to the various project teams.
- Developed comprehensive project plans with clear timelines, milestones, and budget requirements, ensuring timely delivery of high-quality results.
Senior Clinical Research Coordinator
Singhealth Investigational Medicine Unit
05.2011 - 05.2015
- Provided research support service for clinical trials contracted with IMU
- Responsible for project management, administration of clinical trial materials, and performing trial-related duties and/or medical procedures
- Provided training for junior Clinical Research Coordinator and internship students
- Planned curriculum for Clinical Research Coordinator programs in Singhealth
- Involved in Phase I meeting for Clinical Operations
- Wrote and revised SOP for Phase I unit
- Assisted in audit preparation in clinical trial unit and hospital to ensure compliance
- Managed project team members
- Approved study budgets
- Responsible for key study performance indicators
- Assisted in reviewing clinical study reports
- Reviewed CRA's monitoring report
- Built good relationships with sponsor and principal investigator
- Provided problem-solving for CRA, sponsor, and investigator
- Provided supervision, quality review, and oversight management.
Clinical Research Coordinator, lead team leader (special project)
Department of Hematology-Oncology, National University Hospital
03.2009 - 04.2011
- 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.
Clinical Research Coordinator
Department of Hematology-Oncology, NUHS Hospital
06.2002 - 03.2009
- 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.
Enrolled Nurse
John Hopkins - NUH IMC (Oncology Dept.)
01.2001 - 01.2002
- Assisted in outpatient clinic and treatment area performing clinical procedures such as infusion administration, IV cannulation, venepuncture, port-cath insertion, pleural tap, and ECG.
Enrolled Nurse
National University Hospital,
01.1988 - 01.2001
- 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.
Education
Graduate Diploma in Psychotherapy and Counselling -
The School of Positive Psychology
Bachelor of Biomedical Science -
Central Queensland University
Skills
- Project management and communication
- Problem Solving
- Customer service / Client relations (Mandarin and English)
- Presentation and communication skills
- Good team player with excellent planning, organizational, facilitation and interpersonal skills
- Highly flexible and adaptable with willingness to learn
- Problem-solving aptitude
- Clinical trial management
- Investigator relations
- Research Experience
Certification
- Cultivate Workplace Relationship, 06/24/13, Singapore, Certificate of Attendance
- Manage Achievement of Results, 10/23/12, Singapore, Certificate of Attendance
- Strategic Clinical Trials Project Management 2012 Training Course, 02/21/12 - 02/22/12, Singapore, Statement of Attainment
- CPR +AED, 09/05/11, Singapore, Pass
- CITI Basic Course, 05/29/11, Singapore, Passed
- Effective Subject Recruitment Workshop, 08/06/10, Singapore, NA
- Proper Conduct of Research Intermediate I (PC201), 07/04/10, Singapore, NA
- ASCO, 06/04/10 - 06/08/10, Chicago
- Certificate of Advanced Course on Pharmacovigilance, 07/28/06, Singapore, Certificate of Advanced Course on Pharmacovigilance
- Problem Solving And Creativity, 09/17/03, Singapore, Certificate of Accomplishment
- Venepuncture Course. National University of Singapore, 06/24/03, Singapore, Certificate of Accomplishment
Introduction
Norita joined PRA in Feb 2019 as Senior Clinical Research Associate, embedded to Novartis Global Drug Development and Trial Monitoring Operations, with 23 years of Clinical Research experiences. I obtained my Bachelor Degree in Biomedical Science in July 2009 and graduated as a Nurse in June 1988 with broad understanding of medical conditions and illnesses. I joined National University Hospital, Hematology and oncology Department, in 2002 as a Clinical Research Coordinator and have gained a lot of Clinical Research Experience in phase I to III oncology Clinical Trials. In July 2010, I was promoted to Clinical Research Coordinator, lead team leader (Special project) where I supervised and mentorship to junior coordinator, implemented work flow, reviewed quality of work and ensure studies compliance of the Clinical Research Coordinators. In May 2011, I joined SingHealth Investigational Medicine Unit, as Senior Clinical Research Coordinator by providing Training for junior Clinical Research Coordinator and internship students, Planned curriculum for Clinical Research Coordinator programmes in Singhealth, involved in Phase I meeting for Clinical Operations, And wrote and revised Phase I unit SOP and planning budget for new study. In Jun 2015, joined CMIC as Senior Project Specialist by Supporting Project management, clinical monitoring and/or regulatory affairs operations in all aspects of assigned projects and Project Manager to one regional phase III oncology study handling all aspects of project administration and was in charge of 5 countries: Taiwan (2 sites), Malaysia (4 sites), Singapore (2 Sites), Thailand (4 sites) and US (1 site) and also providing support, i.e. problem solving for CRA, sponsor and investigator. In November 2016, I switched roles to become Senior Clinical Research Associate, in charges of six studies. Three sites were audited with no major finding and issues. I have a very good rapport with the sites, Investigators and Sponsors with positive feedback. I am able to communicate in English, Mandarin and Malay.
Professional Licenses
Singapore Nursing Board Practicing Certificate, 12/31/2024, Singapore
Publications
- Post-treatment tumor gene expression signatures are more predictive of treatment outcomes than baseline signatures in breast cancer.
- Chemotherapy-induced tumor gene expression changes in human breast cancers.
- A phase I study of docetaxel with ketoconazole modulation in patients with advanced cancers.
- Genotype of human carbonyl reductase CBR3 correlates with doxorubicin disposition and toxicity.
- Ketoconazole renders poor CYP3A phenotype status with midazolam as probe drug.
- Phase I and Biomarker Study of ABT-869, a Multiple Receptor Tyrosine Kinase Inhibitor, in Patients With Refractory Solid Malignancies
Languages
Chinese (Mandarin)
Upper intermediate (B2)
Malay
Advanced (C1)
English
Bilingual or Proficient (C2)
Timeline
Senior Clinical Research Associate
PRA Health Sciences
02.2019 - Current
Senior Clinical Research Associate
CMIC Asia-Pacific Pte Ltd
11.2016 - 01.2019
Project Manager
CMIC Asia-Pacific Pte Ltd
06.2015 - 01.2019
Senior Clinical Research Coordinator
Singhealth Investigational Medicine Unit
05.2011 - 05.2015
Clinical Research Coordinator, lead team leader (special project)
Department of Hematology-Oncology, National University Hospital
03.2009 - 04.2011
Clinical Research Coordinator
Department of Hematology-Oncology, NUHS Hospital
06.2002 - 03.2009
Enrolled Nurse
John Hopkins - NUH IMC (Oncology Dept.)
01.2001 - 01.2002
Enrolled Nurse
National University Hospital,
01.1988 - 01.2001
Graduate Diploma in Psychotherapy and Counselling -
The School of Positive Psychology
Bachelor of Biomedical Science -
Central Queensland University
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