Christine Da Costa
Cooper City,FL
Summary
To seek and maintain full-time position that offers professional challenges utilizing interpersonal skills, excellent time management and problem-solving skills.
Overview
19
19
years of professional experience
1
1
Certification
Work History
ClinOps Safety Alert Reporting
Eisai
2024.05 - 2024.08
- 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 in order 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 in order 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
2022.01 - 2024.01
- 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.
Senior Clinical Trials Associate
Biorasi
2018.01 - 2022.01
- 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
2017.01 - 2018.01
- 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
2015.01 - 2017.01
- 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
2011.01 - 2013.01
- 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
2006.01 - 2011.01
- 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.
Education
Associate of Science in Medical Assisting -
Keiser College
Fort Lauderdale, FLCertified Medical Assistant -
Keiser Career Institute
Cooper City, FLSkills
- Portfolio Management
- Assertiveness
- Claims Management
- Data Interpretation
Clinicalresearchexperience
- 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
Certification
- Certified Clinical Research Coordinator
- Certified Medical Assistant
- GCP training
Computer Experience
- Microsoft Office (Excel, Word, Outlook, PowerPoint, MS Teams)
- EDC Databases: Inform, Medidata Rave, Oracle, IBM, FDB
- ETMF: Veeva Vault, Box, Trial Box
- IRB: WCG/Connexus, CIRB
- Others: ZenQMS (training system), Canfield Images (imaging system), Mimeo (printing service), psiXchange, Budget Navigator
Timeline
ClinOps Safety Alert Reporting
Eisai
2024.05 - 2024.08
Senior Clinical Project Associate
Biorasi
2022.01 - 2024.01
Senior Clinical Trials Associate
Biorasi
2018.01 - 2022.01
Certified Clinical Research Coordinator
Precision Clinical Research
2017.01 - 2018.01
Certified Clinical Research Coordinator
Delray Medical Center
2015.01 - 2017.01
Certified Clinical Research Coordinator
Miami Children’s Hospital
2011.01 - 2013.01
Certified Clinical Research Coordinator
Broward Research Group
2006.01 - 2011.01
Associate of Science in Medical Assisting -
Keiser College
Certified Medical Assistant -
Keiser Career Institute
- Certified Clinical Research Coordinator
- Certified Medical Assistant
- GCP training
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