Celeste N Rojas Email & Phone Number

Santa Monica, California, US

• Lead and oversee all components of assigned study partnership/collaboration with CPM
• Oversee all interactions and deliverables from relevant CROs and vendors
• Provides guidance and training to team members, CRO, vendors and investigators on study requirements
• Oversee adherence to study timelines, including documentation and communications
• Provides input into study protocols and oversee the development of the content for all study plans and study documents
• Ensures teams’ work complies with established practices, policies and any regulatory or other requirements

Tarrytown, New York, US

• Lead and oversee the planning and management of a clinical study in an assigned region(s) in alignment with the global study plans
• Contributes to risk assessment and helps identify risk mitigation strategies
• Supports feasibility assessment to select relevant regions and countries
• Leading all aspects of and contributing to the development of study specific documentation e.g. case report forms (CRF), DM plan, study operation plan, data review plan, statistical analysis plan
• Reviews and approves site level informed consents and other patient-facing study start-up materials
• Oversees setting up and maintenance of study systems including but not limited to Clinical Trial Management System (CTMS) and Trial Master File (TMF) Contributes to investigator meeting preparation and execution

Tarrytown, New York, US

*Organizes and delivers analyzable reports and metrics to the clinical study leader*Schedules and coordinates meetings, prepares agendas, presentation materials and minutes forclinical study team meetings and other study related meetings*Collates data for assessments such as feasibility and site selection and reviews site usability database*Contributes to.

Social Work Research Course for Master Program

New York, New York, US

* Abstracting data from electronic medical records.* Using proprietary software system to enter the data into database* Responsible for providing feedback to the team about the software being used.* Resolving conflicts when database fields are missing or incomplete.* Help interpret and organize clinical oncology data.

New York, New York, US

• Oversees performance of CRC, including co-monitoring, to ensure compliance with study protocol and in accordance with scope of work, identify areas of concern and escalate to Director as appropriate.
• Perform clinical data review of data listings and summary tables, including query generation.
• Develop and maintain good working relationship with investigators, study staff and sub sites.
• Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by FDA and sponsors.
• Ensure studies are carried out according to the study protocol, SOPs and ICH/GCP regulations and study-specific manuals and procedures
• Track and report on progress of study including site activation, patient enrollment, monitoring visits

New York, New York, US

* Partner with the Principal Investigator and Co-investigators in obtaining and updating all site-specific study requirements including IRB submissions, amendments and revisions* Collaborate with multiple parties and departments in preparing for U. S. Food and Drug Administration (FDA) audits and required interim reports for FDA-sponsored clinical trials*.

New York, NY, US

• Responsible for screening potential research participant, verifying patient eligibility and registering patients on to appropriate studies
• Ensured that all study subjects are followed with strict adherence to the study protocol
• Coordinated all the day-to-day aspects of the study related procedures; assist with scheduling of tests and appointments
• Managed data collection and submission; collect, process and ship protocol specimens, maintain data bases; maintain detailed study files and completes Case Report Forms (CRF) as required
• Assisted the Principal Investigator and Co-investigator in obtaining and updating all site-specific study requirements including IRB submissions, updates and revision
• Executed and managed all regulatory matters associated with clinical trials including but not limited to NYUMC IRB submissions, renewals, amendments, serious adverse events and all other documents required by the IRB.

New York, New York, US

• Responsible for screening potential research participant, verifying patient eligibility and registering patients on to appropriate studies
• Ensured that all study subjects are followed with strict adherence to the study protocol
• Coordinated all the day-to-day aspects of the study related procedures; assist with scheduling of tests and appointments
• Managed data collection and submission; collect, process and ship protocol specimens, maintain data bases; maintain detailed study files and completes Case Report Forms (CRF) as required
• Assisted the Principal Investigator and Co-investigator in obtaining and updating all site-specific study requirements including IRB submissions, updates and revision
• Executed and managed all regulatory matters associated with clinical trials including but not limited to NYUMC IRB submissions, renewals, amendments, serious adverse events and all other documents required by the IRB.

New York, New York, US

• Coordinate pts to start clinical trial (screening for trial, obtaining records, schedules for treatment)
• Maintain medical records to Hospital compliance standards
• Work with insurance company to obtain pre-certifications on tests needed pre and post treatments
• Answer phones, and triage patients issues to appropriate person
• Help with day to day request that comes into office
• Write letters on behalf of patients for multiple things (insurance, work etc.)

Master’S Degree, Bioethics/Medical Ethics

Certificate, Post Baccalaureate Health Science Program

Bachelor Of Science (B.S.), International Business