I joined IQVIA RDS Philippines in 2010. I have provided support in Trial Master File (TMF), study supplies, safety letter distribution and tracking, updating of clinical systems and site payment management. I had supported various projects in the last 5 years as Clinical Trial Assistant, maintaining in-house files, updating clinical systems like CTMS, Informatics and other external project systems in the following Therapeutic Areas: oncology, psychiatry and stroke. I became a Clinical Research Associate in 2014. I have performed Site Selection visit for Oncology, Vaccine, SLE and Infectious Diseases therapeutics. I have conducted Site Initiation and Site Interim visits for Vaccine, Lupus Nephritis, Infectious Disease, Gastric Ulcer, Duodenal Ulcer and DM studies. In addition, I have completed Closeout visits for Vaccine, Lupus Nephritis, Infectious Disease, Gastric Ulcer and Duodenal Ulcer. Further, 1 of my projects underwent Local FDA and USA FDA Inspection with no Form 483.
SKILLS:
Team Player Decision Making
Critical Thinker Collaboration
WORK EXPERIENCE:
Clinical Research Associate 2
IQVIA RDS Philippines (previously Quintiles) (July 2019 – up to present)
Indications: Flu, Dengue, Lupus Nephritis, Adult Tuberculosis, Gastric and Duodenal Ulcers, Diabetes with Hypertension and Dyslipidemia and SLE
➢ Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice.
➢ Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.
➢ 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 to Clinical Project Manager (CPM), Clinical Research Specialist (CRS) and/or line manager.
➢ 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.
➢ 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.
➢ May provide assistance to less experienced clinical staff.
Therapeutic Experience:
Lupus Nephritis: Phase II
2 Sites
Performed site interim visit and closeout visit. Completed CAPA from Sponsor Audit.
Influenza Vaccine: Phase III
3 Sites
Performed Initiation, Interim and closeout visits. Prepared and completed Sponsor Audit with no critical and major observations.
Dengue Vaccine: Phase III
3 Sites
Performed Interim and closeout visits. Prepared and completed local FDA and US FDA with no critical observation and no form 483.
Tuberculosis: Phase III
4 Sites
Performed Initiation, Interim and closeout visits. Prepared and completed Sponsor Quality visit with no critical and major observations. Initially handled 2 sites but as per Sponsor’s request, managed 4 sites and 1 local central laboratory.
DM with Hypertension and Dyslipidemia: Phase III
3 Sites
Performed Initiation and ongoing Interim visits.
SLE-Lupus Nephritis: Phase III
2 Sites
Performed ongoing Interim visits and preparing for Final database lock and closeout visits.
Gastric and Duodenal Ulcers: Phase III
4 Sites
Performed Initiation, Interim and Closeout visits. Earned eTMF Excellence Award.
Clinical Research Associate, IQVIA RDS Philippines (previously Quintiles)
July 2014 – July 2019
Clinical Research Associate Trainee
January 2014 – July 2014
Senior Clinical Trial Assistant
April 2013 – December 2013
Clinical Trial Assistant
October 2010 – April 2013
Marketing Admin/CME Assistant for International Conventions
March 2009 – October 2010
Medical Information Search Specialist
August 2004 – May 2008
Other Relevant Information: Category Experience
Inform
5
Medidata Rave
3-4
OC-RDC
1-2
EDC-Other
3-4
In-House Monitoring Experience: ≥2 Years
Yes
On-Site Monitoring Experience: ≥2 Years
Yes
Conducting GCP Training
Yes
Drug Accountability
Yes
Investigator Meeting Attendance
Yes
Management of SAEs
Yes
Monitoring Visits & Source Data Verification
Yes
Query Resolution
Yes
Reg Body and/or Ethics Comm Submissions
Yes
Local FDA Inspection
Yes
US FDA Inspection
Yes
Contract Negotiation
Yes