Rochelle O. Quiambao
Murrieta,CA
Summary
Collaborative leader with dedication to partnering with team members to promote engaged, empowering work culture. Experienced in clinical trial management, team development and process improvement. Skilled in developing and implementing strategies to increase efficiency and performance. Passionate about driving business growth and creating positive work environment.
Overview
18
18
years of professional experience
Work History
Associate Director, Clinical Trial Management
Precision For Medicine
02.2022 - 08.2023
- Assisted senior leadership in managing all aspects of operations.
- Maintain and report metrics for trial tracking and clinical site performance, including study start-up, patient recruitment and retention.
- Perform clinical oversight on complex projects to ensure timely completion of deliverables.
- Assisted in organizing and overseeing assignments to drive operational excellence.
- Develop study plans, informed consent forms, eCRFs, site instructions, patient-facing materials, study drug accountability logs, and source documents.
- Maintained positive customer relations by addressing problems head-on and implementing successful corrective actions.
- Cultivated positive rapport with fellow employees to boost company morale and promote employee retention.
- Established performance goals for employees and provided feedback on methods for reaching those milestones.
- Collaborate with Data Management, Biostatistics, and Clinical Science team in eCRF template development.
- Review monitoring reports for compliance to study protocols and GCP.
- Coordinate and drive identification, assessment, and selection of study vendors, i.e. central laboratories and imaging providers.
- Manage study resourcing and clinical site budgets.
- Participate in qualification, initiation and close-out of clinical trial sites.
- Provide input in clinical standard operating procedures.
- Lead department initiatives i.e., department trainings, hosting department meetings, interviewing potential candidates.
- Communicate with trial site staff and investigators to support the relationship between the sponsor, CRO, and site.
Senior Clinical Trial Manager
Precision For Medicine
12.2016 - 02.2022
- Primary Clinical interface with Client, as well as internal team including Project Management, Data Management, Safety, Regulatory and Biostatistics departments to ensure the timely initiation, maintenance and completion of clinical trials.
- Coordinates the activities of assigned employees and contract Clinical Operations team members; designates site assignments.
- Review monitoring visit reports and track visit schedule and report finalization to ensure compliance with monitoring plan.
- Responsible for the development and maintenance of the Trial Master File and Investigative Site Files.
- Ensures CRA and CTA resources and other project resources are continuously adequate; interviews and selects CRAs and CTAs for studies.
- Ensures standards for monitoring and adverse event reporting requirements are met within SOPs, government regulations and GCP/ICH guidelines.
- Coordinates study specific training and other requirements for internal and external staff and vendor staff.
- Manage full-service, large-scale, complex projects. Work with other assigned vendors to ensure Clinical personal are trained on vendor processes.
- In collaboration with Project Manager, interacts with study clients and vendors to ensure that contractual obligations related to clinical activities are met.
- Liaison between Clinical staff, investigative sites and sponsor of study. Informs sponsor of site questions regarding protocol eligibility criteria and study processes.
- Participates in initial client meetings identifying clinical study objectives and deliverables.
- Development of clinical documents such as, clinical monitoring plans (CMP), study reference manuals, regulatory binders, pharmacy accountability manuals, CRA tracking tools, informed consent forms and source document templates.
- Coordinates CRA Team Meetings, including development of meeting agendas and minutes.
- Conducts daily, on-going communication via telephone and email responding to inquiries from clinical sites, CRAs and addresses client requests.
- Line management duties including participation in weekly resourcing meetings and providing oversight on clinical projects.
- Contribute to clinical department initiatives including implementation of new systems, training material and department filing structure.
Clinical Trial Manager
SynteractHCR, Inc
07.2014 - 12.2016
- Clinical Lead responsible for participating in the planning, implementation, training, monitoring and management of clinical trials.
- Served as the primary clinical point of contact for Client representatives as well as SynteractHCR team members in order to ensure the timely initiation and completion of clinical trials.
- Development of clinical documents including monitoring plans, study manuals and study forms.
- Responsible for the monitoring of clinical trials, management and training of investigative sites and tracking of study progress including maintenance of study documents.
- Mentoring and training of less senior CRAs.
Senior Clinical Research Associate
SynteractHCR, Inc
04.2011 - 07.2014
- Conducted initiation, monitoring and closeout visits to verify study procedures, regulatory documents and data completion.
- Designed and executed studies to support usability of solutions, analyze data and provide actionable recommendations to project team.
- Managed project risk by identifying, quantifying and monitoring risks.
- Reviewed participant eligibility and consent documentation to help researchers achieve accurate and meaningful results.
CLINICAL RESEARCH ASSOCIATE II
Harbor BioSciences, Inc
01.2009 - 02.2011
- Clinical Lead responsible for clinical project management and site oversight for a Phase II/III clinical research study.
- Assisted in the development of clinical documents, including protocols, ICFs, and Clinical Study Reports.
- Responsible for clinical site monitoring including site qualification, initiation, interim and study closeout visits.
- Responsible for regulatory document review and maintenance of Trial Master File.
- Contributed to CRF design and development.
- Managed study payments and clinical supplies.
Clinical Research Associate
Metabasis Therapeutics, Inc
04.2007 - 11.2008
- Responsible for clinical site monitoring including qualification, initiation, interim monitoring, and closeout visits for Phase I-II clinical research studies.
- Managed clinical databases for tracking enrollment, regulatory documents, and supplies.
- Maintenance of Trial Master File.
- Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
- Interfaced with clinical investigators and site staff to foster ethical research consistent with research plans.
- Liaised with clinical project leader to effectively resolve study-related issues.
- Developed vendor and site agreements and processed payments.
- Assisted in protocol development, clinical study reports, and data listings review.
CLINICAL DOCUMENTS ASSOCIATE
Amylin Pharmaceuticals, Inc
06.2006 - 04.2007
- Responsible for reviewing essential document package to ensure accuracy and completeness.
- Tracked regulatory documents in an Electronic Document Management System to ensure required documents were filed in the TMF.
- Completed IRB submissions for investigative sites.
- Participated in project team meetings.
- Responsible for the distribution and inventory of study supplies for the investigational sites.
CLINICAL DATA ASSOCIATE
Biosite, Inc
08.2005 - 06.2006
- Responsible for verification and data entry of Case Report Forms, query resolution, and data analysis support.
- Organization of CRFs and investigational document maintenance.
- Contributed to CRF development.
- Distribution of clinical supplies to investigational sites.
- Manage specimen storage and inventory.
Education
Master of Science - Regulatory Affairs
San Diego State University
San Diego, CA2015
Bachelor of Science - Biology
San Diego State University
San Diego, CA2005
Therapeutic Experience
- Phase II Pulmonary Arterial Hypertension
- Phase II/III Alpha-1 Antitrypsin Deficiency
- Phase III Blood transfusion
- Phase II Muscle spasm of the back
- Natural History Study in Alport Syndrome
- Phase III Women's health
- Phase I Solid tumor
- Phase II Acute Myeloid Leukemia
- Phase I & II Acute Lymphoblastic Leukemia
- Phase III Glioblastoma Multiforme
- Phase I/II Prostate Cancer
- Phase II Diabetes Milletus
- Phase Ib Lipid metabolism disorder
Timeline
Associate Director, Clinical Trial Management
Precision For Medicine
02.2022 - 08.2023
Senior Clinical Trial Manager
Precision For Medicine
12.2016 - 02.2022
Clinical Trial Manager
SynteractHCR, Inc
07.2014 - 12.2016
Senior Clinical Research Associate
SynteractHCR, Inc
04.2011 - 07.2014
CLINICAL RESEARCH ASSOCIATE II
Harbor BioSciences, Inc
01.2009 - 02.2011
Clinical Research Associate
Metabasis Therapeutics, Inc
04.2007 - 11.2008
CLINICAL DOCUMENTS ASSOCIATE
Amylin Pharmaceuticals, Inc
06.2006 - 04.2007
CLINICAL DATA ASSOCIATE
Biosite, Inc
08.2005 - 06.2006
Master of Science - Regulatory Affairs
San Diego State University
Bachelor of Science - Biology
San Diego State University