Sunwha Lee
North York,Ontario
Summary
Experienced as a CRA Manager, CRA, Clinical Research Coordinator for over 12 years, and RN for over 7.5 years in the Clinical Research Industry and Direct Patient Care, respectively. Excellent reputation for resolving problems and improving customer satisfaction
Overview
22
22
years of professional experience
Work History
Clinical Manager
PPD Development
04.2019 - 02.2021
- Responsible for the line management, selection, training, coaching and performance management of Clinical Research Associates (CRAs)
- Focus on end results to be achieved, use metrics and key performance indicators to manage individual and team performance, including completion of a monthly risk dashboard to identify concerns with CRAs
- Communicate with project Clinical Team Managers on a regular basis regarding CRA performance, areas of development, study status, deliverables and directives to obtain necessary information for the management and evaluation of assigned CRAs
- Review and approve timesheets for correct utilization of time as relates to current assigned projects
- Manage CRA resources and office issues including review of expense claim, payments and purchases
- Attendance of sponsor meeting as a local contact of Korea
Associate Clinical Manager
PPD Development
09.2015 - 03.2019
Line Management-Secondment
PPD Development
06.2016 - 08.2016
Sr. Clinical Research Associate
PPD Development
10.2015 - 05.2016
- Attend sponsor calls and internal team calls to stay informed of current study issues
- Perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products and/or medical devices
- Conduct site visits to determine protocol and regulatory compliance and prepared required documentation
- Develop collaborative relationships with investigative sites, client company personnel and study vendors
- Performed pre-study and site initiation visit with relevant procedures
- Tracked enrollment status reports to ensure study stayed on track to meet enrollment goals
- Tracked study-specific status reports to ensure all required information regarding site issues, deviations, and CRF status were kept current by the monitoring team
- Verified data versus source documentation and validate CRF entries
- Generated and resolve queries as required
- Performed Serious Adverse Event reconciliation and work with sponsor and study sites to resolve discrepancies
- Controlled investigational product accountability through physical inventory and records review
- Controlled trial supplies ordering, dispatch, return and destruction, where applicable
- Prepared and submit ethics committee and provincial applications
- Ensured the proper essential documents are in place on an ongoing basis throughout the study
- Provided trial status tracking and progress reports as required by the Project Manager or Clinical Team Manager
- Administered investigator payments
- Conducted and ensure proper trial close out and retrieval of trial materials
- Archived relevant documents as per procedures
- Clearly documented all observations in reports and letters in a timely manner, according to accepted business writing standards
- Ensured that any serious issues are immediately raised to the attention of project management, clinical team management and clinical operations management in writing
- Maintained a working knowledge of GCP, Corporate global SOPs and applicable client SOPs
- Facilitated effective communication between investigational sites and the PPD project team through written, oral and electronic contacts.
Caregiver Intructor
Vinda Korea
04.2015 - 09.2015
- Worked well in a team setting, providing support and guidance.
Sr. Clinical Research Associate
PPD Development
10.2012 - 03.2015
Clinical Research Associate
PPD Development
06.2012 - 09.2012
Senior Clinical Research Assocaite
C&R Research Inc
08.2010 - 06.2012
Clinical Research Associate
C&R Research Inc.
04.2009 - 07.2010
Clinical Research Coordinator
Seoul National University Hospital
08.2008 - 03.2009
- Coordinated various phase III-IV clinical trials in Stroke and hypertension: Assisted subject screening and enrollment, collected data and completed CRFs, Supported on AE/SAE reporting and IRB submission
- Performed and coordinated assigned aspects of the clinical trial process in accordance with GCPs and global SOPs.
- Sample preparation, shipping and storage
- Assisted ICF obtaining
RN Staff Nurse
Asan Medical Center
11.2004 - 02.2007
- Provided direct patient care, stabilized patients, and determined next course of action in dermatology department
RN, Medical-Surgical
Asan Medical Center
09.1999 - 10.2004
- Administered medications via oral, IV, and intramuscular injections and monitored responses.
- Organized and managed care of patients undergoing various therapies and procedures.
- Trained new nurses in proper techniques, care standards, operational procedures, and safety protocols.
- Managed care from admission to discharge.
- Collected blood, tissue, and other laboratory specimens and prepared for lab testing.
RN, ICU
Bundang Cha Medical Center
02.1999 - 07.1999
- Provided exceptional care to high-acute patients needing complex care such as ventilator management, extensive wound care and rehabilitation.
- Collaborated with physicians to quickly assess patients and deliver appropriate treatment while managing rapidly changing conditions.
Education
Diploma - Pre-health Science And Healthcare Management
Northern College of Applied Arts And Technology
Toronto, ON08.2023
Bachelor of Science - Nursing Science
Ewha Womans University
Seoul, South Korea03.1999
Skills
- Windows Applications, MS Office Applications, CTMS, EDC, eTMF, EMR
Accomplishments
- Hematology: Multi-national, phase 1 clinical trial in subjects with Diffuse Large B-Cell Lymphoma
- Hematology: Multi-national, phase 3 clinical trial in subjects with LTBFL
- Oncology: Multi-national, phase 2 clinical trial in subjects with NSCLC
- Oncology: Multi-national, phase 3 clinical trial in subjects with Thyroid Cancer
- Oncology: Multi-national, phase 3 clinical trial in subjects with Ovarian Cancer
- Musculoskeletal: Multi-national, phase 3 clinical trial in subject with rheumatoid arthritis
- Infection Diseases: Multi-national, phase 3 clinical trial in subjects with CDAD
- Respiratory Diseases: Multi-national, phase 3 clinical trial in subjects with Pneumonia
- Clinical trial experience completed prior to PPD:
- Oncology: Multi-national, phase 3 clinical trial in subjects with lung cancer
- Oncology: Multi-national, phase 3 clinical trial in subjects with breast cancer
- Nervous system-Sense: Multi-national, phase 3 clinical trial in subjects with age-related macular degeneration
- Musculoskeletal: Multi-national, phase 3 clinical trial for prosthetic device in subjects with impaired femoral condyle
- Mental Disorders: Multi-center, phase 4 clinical trial in subjects with bipolar disorder
- Circulatory: Multi-national, phase 3 clinical trial in subjects with atrial fibrillation
- Respiratory: Multi-national, phase 2 clinical trial of Pneumoccocal conjugated Vaccine
Affiliations
Member of Korean Nurse Association since 1999
Additional Information
- Registered Nurse License No/Country: #142147/ Korea, Feb 1999
- NCLEX-RN, License No/Country: #538092/ New York, Jan 2003
Timeline
Clinical Manager
PPD Development
04.2019 - 02.2021
Line Management-Secondment
PPD Development
06.2016 - 08.2016
Sr. Clinical Research Associate
PPD Development
10.2015 - 05.2016
Associate Clinical Manager
PPD Development
09.2015 - 03.2019
Caregiver Intructor
Vinda Korea
04.2015 - 09.2015
Sr. Clinical Research Associate
PPD Development
10.2012 - 03.2015
Clinical Research Associate
PPD Development
06.2012 - 09.2012
Senior Clinical Research Assocaite
C&R Research Inc
08.2010 - 06.2012
Clinical Research Associate
C&R Research Inc.
04.2009 - 07.2010
Clinical Research Coordinator
Seoul National University Hospital
08.2008 - 03.2009
RN Staff Nurse
Asan Medical Center
11.2004 - 02.2007
RN, Medical-Surgical
Asan Medical Center
09.1999 - 10.2004
RN, ICU
Bundang Cha Medical Center
02.1999 - 07.1999
Diploma - Pre-health Science And Healthcare Management
Northern College of Applied Arts And Technology
Bachelor of Science - Nursing Science
Ewha Womans University
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