Naomi Ocampo
Fairfield,CA
Summary
Clinical research professional with solid foundation in managing complex clinical trials and ensuring regulatory compliance. Adept at fostering collaborative team environments and driving successful project outcomes. Reliable and adaptable with focus on achieving results and maintaining high standards.
Thorough with extensive background in overseeing clinical trials from initiation to close-out. Proven record in ensuring protocol compliance and managing site performance. Demonstrated proficiency in regulatory documentation and team collaboration.
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.
Hardworking and passionate job seeker with strong organizational skills eager to secure position. Ready to help team achieve company goals.
Pursuing full-time role that presents professional challenges and leverages interpersonal skills, effective time management, and problem-solving expertise.
Overview
25
25
years of professional experience
1
1
Certification
Work History
Associate Clinical Project Manager
Nestle Health Science (Aimmune Therapeutics)
01.2023 - 12.2024
- Independently manages the study start up activities for multi-center, US and/or global based studies
- Independently creates project specific documents and tools e.g. Study manuals, tracking spreadsheets, training tools/materials, etc.
- Assist with the development of new studies, including protocol review, ICF development, CRFs review, tracking forms and other study related documents.
- Participated in vendor audit and assisted in audit activities, e.g. review staff CVs, training records and SOPs, etc.
- Lead vendor management activities (IRT, Central Lab, DM)
- Conduct study site visits for the purpose of assessing the site’s ability to conduct the trial effectively and continuously as per SOPs and study guidelines
- Mentor and coach junior staff new to Clinical Research; CTAs
Senior Clinical Research Associate
Nestle Health Science (Aimmune Therapeutics)
08.2016 - 01.2023
- Independently manages the study start up activities for multi-center, US and/or global based studies
- Independently creates project specific documents and tools e.g. Study manuals, tracking spreadsheets, training tools/materials, etc.
- Assist with the development of new studies, including protocol review, ICF development, CRFs review, tracking forms and other study related documents.
- Participated in vendor audit and assisted in audit activities, e.g. review staff CVs, training records and SOPs, etc.
- Lead vendor management activities (IRT, Central Lab, DM)
- Conduct study site visits for the purpose of assessing the site’s ability to conduct the trial effectively and continuously as per SOPs and study guidelines
- Mentor and coach junior staff new to Clinical Research; CTAs
Senior Clinical Research Associate
NovaBay Pharmaceuticals, Inc.
10.2012 - 03.2016
- CRO oversight including management of study start-up, clinical site initiations, site budget review and approval, and study close-out activities
- Participated in investor relations meetings for potential partners for the Urology program
- Partnered with data management to EDC system go-live for the study
- Participated in data review for interim analysis and assisted in data query resolution process
- Reported study updates to the CEO
- Updated and maintained study status in clinicaltrials.gov
- Assisted in identification and selection of qualified investigators
- Conducted Clinical Site Pre-Qualification, Initiation, Interim Monitoring and Close Out Visits and performed remote data monitoring
- Reviewed and approved clinical trial packages prior to shipment of IMP to sites
- Maintained up-to-date Clinical Trial Master Files
- Reviewed protocols, CRFs and other clinical documents
Clinical Research Associate II
NovaBay Pharmaceuticals, Inc.
08.2008 - 10.2012
- CRO oversight including management of study start-up, clinical site initiations, site budget review and approval, and study close-out activities
- Participated in investor relations meetings for potential partners for the Urology program
- Partnered with data management to EDC system go-live for the study
- Participated in data review for interim analysis and assisted in data query resolution process
- Reported study updates to the CEO
- Updated and maintained study status in clinicaltrials.gov
- Assisted in identification and selection of qualified investigators
- Conducted Clinical Site Pre-Qualification, Initiation, Interim Monitoring and Close Out Visits and performed remote data monitoring
- Reviewed and approved clinical trial packages prior to shipment of IMP to sites
- Maintained up-to-date Clinical Trial Master Files
- Reviewed protocols, CRFs and other clinical documents
Clinical Research Associate I
Titan Pharmaceuticals, Inc.
01.2006 - 04.2008
- Conducted Clinical Site Initiation, Interim Monitoring and Close Out visits
- Contacted investigational sites to ensure they were adequately informed about the study, maintained awareness of site-specific details, status, and problems in compliance with protocol, FDA, GCPs and pertinent SOPs. Worked with the study team to develop solutions/corrective actions.
- Prepared visit reports and maintained written correspondence (letters, e-mail) and telephone contacts with sites
- Assisted in tracking enrollment activity
- Participated in data listing review and assisted in data query writing and resolution process
- Responsible for the collection of essential documents from Investigators/clinical sites, assembling Clinical Trial Packages and review and approval of the completed Clinical Trial Packages for initial shipment of investigational product
- Reviewed regulatory documents, IRB approvals, ICFs, HIPAA forms, and assisted in processing Central IRB submissions
- Assisted in preparation and processing of quarterly clinical site payments
- Interacted with other functional groups (i.e., manufacturing/materials management, regulatory) as well as vendors, including CRO, core lab, compounding pharmacy, and data management
- Assisted in the preparation of Protocols, CRFs, ICFs, and relevant clinical portions of Investigator’s Brochures, study manuals, study newsletters, and clinical study reports
Senior Clinical Project Assistant
Titan Pharmaceuticals, Inc.
01.2004 - 04.2006
- Conducted Clinical Site Initiation, Interim Monitoring and Close Out visits
- Contacted investigational sites to ensure they were adequately informed about the study, maintained awareness of site-specific details, status, and problems in compliance with protocol, FDA, GCPs and pertinent SOPs. Worked with the study team to develop solutions/corrective actions.
- Prepared visit reports and maintained written correspondence (letters, e-mail) and telephone contacts with sites
- Assisted in tracking enrollment activity
- Participated in data listing review and assisted in data query writing and resolution process
- Responsible for the collection of essential documents from Investigators/clinical sites, assembling Clinical Trial Packages and review and approval of the completed Clinical Trial Packages for initial shipment of investigational product
- Reviewed regulatory documents, IRB approvals, ICFs, HIPAA forms, and assisted in processing Central IRB submissions
- Assisted in preparation and processing of quarterly clinical site payments
- Interacted with other functional groups (i.e., manufacturing/materials management, regulatory) as well as vendors, including CRO, core lab, compounding pharmacy, and data management
- Assisted in the preparation of Protocols, CRFs, ICFs, and relevant clinical portions of Investigator’s Brochures, study manuals, study newsletters, and clinical study reports
Clinical Research Specialist
Titan Pharmaceuticals, Inc.
01.2002 - 04.2004
- Conducted Clinical Site Initiation, Interim Monitoring and Close Out visits
- Contacted investigational sites to ensure they were adequately informed about the study, maintained awareness of site-specific details, status, and problems in compliance with protocol, FDA, GCPs and pertinent SOPs. Worked with the study team to develop solutions/corrective actions.
- Prepared visit reports and maintained written correspondence (letters, e-mail) and telephone contacts with sites
- Assisted in tracking enrollment activity
- Participated in data listing review and assisted in data query writing and resolution process
- Responsible for the collection of essential documents from Investigators/clinical sites, assembling Clinical Trial Packages and review and approval of the completed Clinical Trial Packages for initial shipment of investigational product
- Reviewed regulatory documents, IRB approvals, ICFs, HIPAA forms, and assisted in processing Central IRB submissions
- Assisted in preparation and processing of quarterly clinical site payments
- Interacted with other functional groups (i.e., manufacturing/materials management, regulatory) as well as vendors, including CRO, core lab, compounding pharmacy, and data management
- Assisted in the preparation of Protocols, CRFs, ICFs, and relevant clinical portions of Investigator’s Brochures, study manuals, study newsletters, and clinical study reports
Clinical Study Assistant
Chiron Corporation
10.2001 - 12.2002
- Assisted CRAs with in-house monitoring, following SOPs, regulatory guidelines, and GCP
- Assisted with tracking and labeling of regulatory documents and other study-related documentation, and periodic review of the Trial Master Files (TMFs)
- Assisted CRAs with purchasing, assembling, and distribution of Clinical Trial Supplies (e.g., cryovial tubes, freezer boxes, infectious containers)
- Reviewed and verified data in DCFs, Clinical Trial Packages, and Product Order Request Forms
Project Associate
Quintiles Inc.
08.1999 - 10.2001
- Reviewed all regulatory documents from clinical sites for accuracy and completeness
- Tracked all site and study-specific information for reference by the Clinical Project Manager, and forwarded documentation to Regulatory Staff and Archives department
Education
Bachelor of Science - Nursing
Philippine Christian University – Mary Johnston College of Nursing
Manila, Philippines06.1990
Skills
- Site monitoring
- Clinical trial management
- Patient recruitment
- Adaptive thinking
- Project planning
- Study design
- Training and mentoring
Certification
- Barnett International San Francisco, CA
- Monitoring Clinical Drug Studies (Intermediate), March 2006
- Site Relationship Management, March 2007
- Adverse Events Monitoring for CRAs, October 2007
- Effective Monitoring Report Writing, February 2008
- UC Santa Cruz Extension (21 hrs)
- Clinical Trials Site Monitoring 1, April 2005 (Grade: A)
- ACRP (Assoc. of Clinical Research Professionals)
- Fundamentals of Clinical Research, September 2004
Therapeutic Areas
Medical Nutrition, Food Allergy, Urology, Dermatology, Ophthalmology, Cardiovascular, Opiate Addiction, Immunology, Oncology
Timeline
Associate Clinical Project Manager
Nestle Health Science (Aimmune Therapeutics)
01.2023 - 12.2024
Senior Clinical Research Associate
Nestle Health Science (Aimmune Therapeutics)
08.2016 - 01.2023
Senior Clinical Research Associate
NovaBay Pharmaceuticals, Inc.
10.2012 - 03.2016
Clinical Research Associate II
NovaBay Pharmaceuticals, Inc.
08.2008 - 10.2012
Clinical Research Associate I
Titan Pharmaceuticals, Inc.
01.2006 - 04.2008
Senior Clinical Project Assistant
Titan Pharmaceuticals, Inc.
01.2004 - 04.2006
Clinical Research Specialist
Titan Pharmaceuticals, Inc.
01.2002 - 04.2004
Clinical Study Assistant
Chiron Corporation
10.2001 - 12.2002
Project Associate
Quintiles Inc.
08.1999 - 10.2001
Bachelor of Science - Nursing
Philippine Christian University – Mary Johnston College of Nursing
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