CHRISTINE DACOSTA
Cooper City,USA
Summary
Clinical research experience spanning over 20 years with extensive knowledge in therapeutics, device, nutraceuticals and bio-marker studies. Proactive and goal-oriented professional with excellent time management and problem-solving skills. Known for reliability and adaptability, with swift capacity to learn and apply new skills. Committed to leveraging these qualities to drive team success and contribute to organizational growth.
Overview
20
20
years of professional experience
1
1
Certification
Work History
Senior Clinical Trial Lead
Yanuvia
Boca Raton, FL
01.2025 - Current
- Communication: Partake/lead in meetings/teleconferences/trainings
- Vendor management and scheduling
- Site management
- Remote monitoring
- Managing in-house teams
- Providing oversight and management of the daily and long-term operations of the Sites related to each Company study performed at the Sites (each a “Study” and collectively, the “Studies”), including reviewing and approving all policies and procedures that guide daily operations relating to the studies at the Sites.
- Assisting each investigator at each assigned Site in obtaining any required accreditation
- Overseeing a team assigned to the specific study.
- Working with each assigned Site to ensure compliance with all Study protocols and Good Clinical Practice.
- Such other services as may be requested from time to time by Company
- Ensuring that Company and the Sites are adhering to all applicable regulatory standards
- Helping the investigators and Company design, monitor, and collect accurate data from the Studies.
- Being available for consultation to the Site staff when there is a need for Coordinator input
- Handling all matters with the Institutional Review Board that Company requests from time to time, including changes to any protocols.
- Reviewing all Study protocols with the personnel at the designated/assigned Sites.
CLINOPS SAFETY ALERT REPORTING
Eisai
05.2024 - 08.2024
- Distribution of Safety Alert Reports and Plain Language Summaries globally
- Assist with the processing of all ICSR and Aggregate documents including, but not limited to: SUSARs, IND Safety Alerts, Six Monthly Line Listings, DSURs etc.
- 50% Assist with the maintenance of the safety alert reporting system including, but not limited to: data maintenance, troubleshooting, and validation testing
- 10% Develop and apply an understanding of country specific, Regulatory reporting requirements for 50+ countries worldwide 5% Identify issues with the distribution/receipt of safety alert reports to provide support to the study teams for all inspection readiness activities
- 15% Interact/collaborate with interdisciplinary groups such as Safety, Study Teams, CROs, and IT to resolve distribution issues and resolve incoming inquiries
- 5% Assist with inspection readiness activities including but not limited to running reports, reconciling reports received and distributed, and gathering information for storyboard development 10% Assist with obtaining and tracking key milestone dates including but not limited to Clinical Trial specific SIV, COV, Country Approval, LPLV, and Country Close Out 5%
SENIOR CLINICAL PROJECT ASSOCIATE
Biorasi
Aventura, FL
01.2022 - 01.2024
- Communication: Partake/lead in meetings/teleconferences
- Develop and distribute meeting agendas, minutes, monthly status reports, and action item distribution and tracking to document key project updates and communications to relevant stakeholders, as requested
- Site Management: Assist with the development of sites budgets, contracts, and payments administration
- Support Clinical Trial Managers in tracking subject recruitment at all study sites, track study Monitoring Visits, protocol deviations, reporting and trending
- Assist in communication to sites
- Study Start-up: Support Clinical Trial Managers and Project Managers in the development of project plans and documents required for site feasibility, selection, and activation
- Site Activation: Coordinate with the project team in retrieval and review of regulatory documents required for initiation of a clinical trial
- Document Management: assist [and help drive (Senior)] project team in the collection, review, filing, and archival of essential documents, and maintenance of the Trial Master File
- Supplies Management: Assist with the coordination of / [Coordinates (Senior)] logistics of the project, including printing of study tools and materials, securing study supplies, helping with the distribution, tracking and collection of study supplies and materials
- Track clinical supplies at the site level in coordination with established study systems
- Study Management: Assist project team members to create and maintain / [Creates and maintains (Senior)] project trackers, relevant systems (e.g., CTMS, study portal) routine correspondence messages and distribute to project team, Sponsor, sites, and other stakeholders based on relevance
- Vendor Management: Assist with the / [Performs (Senior)] vendor identification, qualification, selection, and management throughout a clinical trial, including administration of vendor payments
- Compliances: Follow international GCP guidelines/regulations and SOPs for executing clinical studies
- Assist the Project team in the resolution of audit findings; assist project team in review and maintenance of clinical trial documentation for audit readiness
- Assist with financial reconciliation tasks (Senior only) Participate at client presentation meetings and Investigator Meetings (IM) as necessary
- Communicate any out-of-scope issues to upper management as soon as identified
- Assist the study teams in meeting timelines
- May mentor junior Clinical Project Associates in particular tasks (Senior only) Exhibit ability to perform CPA work with minimal support from CTMs and PMs on their assigned projects (Senior Only) Other duties as assigned.
SENIOR CLINICAL TRIALS ASSOCIATE
Biorasi
Aventura, FL
01.2018 - 01.2022
- Communication: Partake in meetings/teleconferences
- Develop and distribute meeting agendas, minutes, monthly status reports, and action item distribution and tracking to document key project updates and communications to relevant stakeholders, as requested
- Site Management: Assist with the development of sites budgets, contracts, and payments administration
- Support Clinical Trial Managers in tracking subject recruitment at all study sites, track study Monitoring Visits, protocol deviations, reporting and trending
- Assist in communication to sites
- Study Start-up: Support Clinical Trial Managers and Project Managers in the development of project plans and documents required for site feasibility, selection, and activation
- Site Activation: Coordinate with the project team in retrieval and review of regulatory documents required for initiation of a clinical trial
- Document Management: assist [and help drive (Senior)] project team in the collection, review, filing, and archival of essential documents, and maintenance of the Trial Master File
- Supplies Management: Assist with the coordination of / [Coordinates (Senior)] logistics of the project, including printing of study tools and materials, securing study supplies, helping with the distribution, tracking and collection of study supplies and materials
- Track clinical supplies at the site level in coordination with established study systems
- Study Management: Assist project team members to create and maintain / [Creates and maintains (Senior)] project trackers, relevant systems (e.g., CTMS, study portal) routine correspondence messages and distribute to project team, Sponsor, sites, and other stakeholders based on relevance
- Vendor Management: Assist with the / [Performs (Senior)] vendor identification, qualification, selection, and management throughout a clinical trial, including administration of vendor payments
- Compliances: Follow international GCP guidelines/regulations and SOPs for executing clinical studies
- Assist the Project team in the resolution of audit findings; assist project team in review and maintenance of clinical trial documentation for audit readiness
- Assist with financial reconciliation tasks (Senior only) Participate at client presentation meetings and Investigator Meetings (IM) as necessary
- Communicate any out-of-scope issues to upper management as soon as identified
- Assist the study teams in meeting timelines
- May mentor junior Clinical Project Associates in particular tasks (Senior only) Exhibit ability to perform CPA work with minimal support from CTMs and PMs on their assigned projects (Senior Only) Other duties as assigned.
CERTIFIED CLINICAL RESEARCH COORDINATOR
Precision Clinical Research
Lauderdale Lakes, FL
01.2017 - 01.2018
- Served as Clinical Research Coordinator in all facets of Phase II-IV research protocols
- Scheduled subject visits
- Recruited subjects
- Maintained regulatory documents and source documents
- EDC completion/query resolution
- Created source documents
- Managed IRB correspondence
- Attended meetings
- Filed documents
- Acquired ECG's, vital signs, venipuncture, laboratory sample processing and shipping
- IVRS trained
- Scheduled and assisted in monitoring visits
- Assisted in sponsor audit
- Dispensed study drug
- Executed study specific protocol procedures.
CERTIFIED CLINICAL RESEARCH COORDINATOR
Delray Medical Center
Delray Beach, FL
01.2015 - 01.2017
- Served as Clinical Research Coordinator in all facets of Phase II-IV research protocols
- Scheduled subject visits
- Recruited subjects
- Maintained regulatory documents and source documents
- EDC completion/query resolution
- Managed IRB correspondence
- Attended meetings
- Filed documents
- Acquired ECG's, vital signs, venipuncture, laboratory sample processing and shipping
- IVRS trained
- Scheduled and assisted in monitoring visits
- Assisted in sponsor audit
- Dispensed study drug
- Prepared for FDA audit
- Prepared for Sponsor audit
- Executed study specific protocol procedures.
CERTIFIED CLINICAL RESEARCH COORDINATOR
Miami Children's Hospital
Miami, FL
01.2011 - 01.2013
- Served as Clinical Research Coordinator in all facets of Phase II-IV research protocols
- Scheduled subject visits
- Recruited subjects
- Maintained regulatory documents and source documents
- EDC completion/query resolution
- Managed IRB correspondence
- Attended meetings
- Filed documents
- Acquired ECG's, vital signs, venipuncture, laboratory sample processing and shipping
- IVRS trained
- Scheduled and assisted in monitoring visits
- Assisted in sponsor audit
- Dispensed study drug
- Prepared for FDA audit
- Prepared for Sponsor audit
- Executed study specific protocol procedures.
CERTIFIED CLINICAL RESEARCH COORDINATOR
Broward Research Group
01.2006 - 01.2011
- Served as Clinical Research Coordinator in all facets of Phase II-IV research protocols
- Scheduled subject visits
- Recruited subjects
- Maintained regulatory documents and source documents
- EDC completion/query resolution
- Managed IRB correspondence
- Attended meetings
- Filed documents
- Acquired ECG's, vital signs, laboratory sample processing and shipping
- IVRS / IWRS trained
- Scheduled and assisted in monitoring visits
- Assisted in sponsor audit
- Dispensed study drug
- Prepared for FDA audit
- Prepared for Sponsor audit
- Executed study specific protocol procedures.
Education
Associate of Science - Medical Assisting
Keiser College
Fort Lauderdale, FL2001
Certified Medical Assistant -
Keiser Career Institute
Cooper City, FL2001
Certification
CPR / AED
CITI GCP
Certified Clinical Research Coordinator (previously)
Timeline
Senior Clinical Trial Lead
Yanuvia
01.2025 - Current
CLINOPS SAFETY ALERT REPORTING
Eisai
05.2024 - 08.2024
SENIOR CLINICAL PROJECT ASSOCIATE
Biorasi
01.2022 - 01.2024
SENIOR CLINICAL TRIALS ASSOCIATE
Biorasi
01.2018 - 01.2022
CERTIFIED CLINICAL RESEARCH COORDINATOR
Precision Clinical Research
01.2017 - 01.2018
CERTIFIED CLINICAL RESEARCH COORDINATOR
Delray Medical Center
01.2015 - 01.2017
CERTIFIED CLINICAL RESEARCH COORDINATOR
Miami Children's Hospital
01.2011 - 01.2013
CERTIFIED CLINICAL RESEARCH COORDINATOR
Broward Research Group
01.2006 - 01.2011
Associate of Science - Medical Assisting
Keiser College
Certified Medical Assistant -
Keiser Career Institute
Therapeutic Areas
Cardiology
Aortic valve replacement
Hypertension
Neurology
Insomnia
Sleep apnea
Fibromyalgia
Alzheimer's Disease
Psychiatry
Active schizophrenia
Opioid addiction
Bipolar Disorder
Nephrology
Acute Kidney Injury (AKI)
Chronic Kidney Disease (CKD)
Gynecology
Chlamydia
Fibroid
Endocrine
Diabetes I
Diabetes II
GFR
Pediatrics
Neurology - Migraines
Psychiatry - Schizophrenia
Autism
Gastroenterology - H. pylori
Bio-marker
Gastroenterology - NASH
Oncology - Solid tumor
RNA
DNA
Nutraceuticals
Shapewear
CLINICAL RESEARCH EXPERIENCE
- Phase III, Randomized, Double-Blind, Placebo-Controlled study for Patients with Uterine Fibroids
- Phase III, Randomized, Cross-Over study for Patients with Insomnia
- Phase II, Randomized, Double-Blind, Placebo Controlled study for Patients with Insomnia
- Phase II, Randomized, Double-Blind, Placebo Controlled study for Patients with schizophrenia
- Phase II, Randomized, Double-Blind, Placebo Controlled study for Patients with aortic valve Replacement
- Biomarker, Early detection of lung cancer based on small RNA signatures
- Biomarker, Sample collection for ongoing research and product evaluation
- Biomarker, DNA evaluation of fragments for early interception – lung cancer
COMPUTER EXPERIENCE
- Microsoft Office (Excel, Word, Outlook, PowerPoint, MS Teams)
- EDC Databases: Inform, Medidata Rave, Oracle, IBM, FDB, Medrio, Zelta
- ETMF: Veeva Vault, Box, Trial Box, One Drive
- IRB: WCG/Connexus, CIRB, Advarra
- Others: ZenQMS (training system), Canfield Images (imaging system), Mimeo (printing service), psiXchange, Budget Navigator, Google Sheets, Ring Central, YDECS, Unifize, Google Sheets, YDECS, Porta Medics, Mural Health