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• Completed full study management, from start-up to close-out• Contributed to SOP development and implementation

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• Oversees engagement, contracting and management of required vendors for the study• Oversees and provides input to study drug and clinical supplies forecasting, • Contributes to development of and oversees implementation of recruitment and retention strategies• Monitoring progress for monitoring visits and acts on any deviations from plan• Supports data quality including regular review of data metrics and listings, protocol deviations, eligibility violations, dosing deviations and suspected non-compliance by sites• Oversees the execution of the specific clinical study deliverables against planned timelines• Supports accurate budget management and scope changes• Ensuring clinical project audit and inspection readiness through the study lifecycle and contributing to CAPAs as required• Manages aspects of study close-out activities including but not limited to database lock, reconciliation of vendor contract, study budget, and study drug accountability• Raising issues related to study conduct, quality, timelines or budget to Program Operations Leader (POL) and other partners and developing and implementing appropriate actions to address issues

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 review of study documents such as informed consent forms, case report forms andfacilitates study document reviews per company standard operating procedures*Compiles study manuals including but not limited to: study reference binders and manuals andmaintains versioning of study reference materials (e.g., regulatory, pharmacy, and laboratory binders*Collates materials for training and investigator meetings*Tracks site activation, enrolment and monitoring visits to projected plans, and escalate any issues or delays with site activation or deviations from monitoring plan*Monitors and updates investigator/site status for the trial, and supports with clinical trial registrypostings*Performs scheduled reconciliations of study Trial Master File (TMF) with clinical study leaderguidance*Ensures scheduled reports are received (i.e. 1572 reportable changes, financial disclosure form)*Manages and maintains team SharePoint and/or shared drive sites, as needed*Communication with sites as directed and maintains site contact information*Contributes to line listings review for Blind Data Review Meeting (BDRM)*May manage or contribute to oversight of Third Party Vendors (TPV)*Tracks and monitors close out activities – study close-out documents (1572s, InvestigationalProduct reconciliation, Financial Disclosures, etc.) and CRA close-out visits*Participates in Standard Operating Procedures (SOPs) revisions or departmental initiatives*Proactively recommends process improvement initiatives for the department

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• Review key study quality metrics (e.g. eligibility, primary endpoint data, etc.) and determine appropriate action in conjunction with study team• Investigate queries and monitor discrepancies• Contribute and review the preparation of clinical protocols, amendments, informed consent forms, study guides, case report forms, and any other clinical research related documents. • Manage data collection and submission; collect, process and ship protocol specimens, maintain databases; maintain detailed study files and completes Case Report Forms (CRF) as required. Contribute in obtaining and updating all site-specific study requirements including IRB submissions, updates and revision. • Assists Principal Investigator with scientific and compliance reporting requirements in accordance with Federal regulations and University and sponsoring agency policies and procedures.

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* Execute and manage all regulatory matters associated with clinical trials including but not limited to Columbia University Medical Center and Western IRB submissions, renewals, amendments, serious adverse events and all other documents required by the IRB, the Sponsor and the FDA* Responsible for screening potential research patients, verifying patient eligibility and registering patients on to appropriate studies* Oversee all the day-to-day aspects of the study related procedures, including, but not limited to, scheduling all visits and procedures, inputting procedures into the CROWN system and ordering protocol specific tests* Manage data collection and VELOS data entry, maintain data bases and complete Case Report Forms (CRF) as required per protocol, including, but not limited to Inform, Rave and Medidata* Perform database queries and analysis for multiple research studies to prepare demographic, toxicity and response summaries* Collaborate with Contract Research Organizations (CRO’s) and other external vendors to ensure studies are conducted according to the timelines, budget and objectives* Develop and implement standard operating procedures, including but not limited to the timely review of IND safety reports and laboratory values* Create and design documents and electronic case report forms to ensure that all study subjects are followed with strict adherence and are compliant to the study protocol* Participates in bi-weekly research meetings, attended by all study staff, to discuss research patients, regulatory matters and projected timelines

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, the Sponsor and the FDA

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, the Sponsor and the FDA

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.)• Work closely with Infusion Center to schedule patient chemotherapy regimen• Assist new patients with medical records retrieval for appointment visit

Master’S Degree, Bioethics/Medical Ethics

Certificate, Post Baccalaureate Health Science Program

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