Christina Sanchez

Served as a key Clinical Operations contributor overseeing IND submission, project timelines and vendor management. Point of contact with counterparts of outside vendors, CRO and/or trial sites.

Responsibilities include:

• Provided oversight and direction to direct and indirect reports, as applicable.
• Participation in bid defense and vendor selections.
• Vendor oversight, including CRO, imaging, central lab, and EDC vendors. Overseeing execution of contracts and budgets; review of vendor specifications, reports and metrics.
• Evaluated CRO and third party vendor performance regularly to ensure compliance with study protocol and SOPs.
• Performed SIVs and protocol training for CRO, sites and third party vendors as needed.
• Managed study financials, including budget negotiations, forecasting, assumptions, invoices and reconciliation.
• Spearheaded selection of appropriate clinical sites by conducting thorough feasibility assessments.
• Managed study submissions to IRB in coordination with CRO in order to meet timelines.
• Key contributor or developer of critical study documents (e.g., Protocol, ICF, study plans, pharmacy manual, eCRF etc.).
• Managed cross-functional teams to ensure timely completion of clinical trial milestones and deliverables.
• Facilitated internal and external cross functional meetings to provide study updates which included site selection, enrollment, safety data, key issues etc.
• Prepared detailed progress reports for stakeholders, keeping them apprised of key developments in ongoing trials.
• Collaborated closely with biostatisticians for accurate statistical analysis planning in support of study objectives.
• Participated in data management activities, including but not limited to UAT, data cleaning, validation, and database lock procedures.
• Mitigated risks in the clinical trial process by proactively identifying potential issues and implementing corrective actions.
• Achieved successful recruitment targets by implementing strategic patient enrollment plans and collaborating with study sites.

Managed multi-center, phase I oncology trials. Primary liaison for assigned CROs, vendors and sites to convey project information and resolve issues in accordance with the CTM escalation pathway.

Responsibilities include:

• Provided oversight and direction to direct and indirect reports.
• Served as mentor for junior CRAs and CTAs and those new to the company and/or clinical trial management.
• CRO and vendor oversight.
• Partnered with CTM for overall project management of trials including preparing meeting agenda, minutes and action items.
• Developed and reviewed regulatory documentation to support study start up activities.
• Key contributor or developer of critical study documents (e.g., Protocol, ICF, study plans, pharmacy manual, eCRF etc.).
• Prepared and presented training slides for PSVs and SIVs.
• Developed annotated MVRs and conducted thorough reviews of study monitoring reports (PSV, SIV, IMV and COV ).
• Monitored site performance and implemented action plans for sites not meeting expectations, in conjunction with the CRA and CTM.
• Oversight of subject recruitment and treatment status remotely through EDC systems and direct communication with sites in order to update detailed tracking sheets daily
• Developed lab sample trackers and maintained oversight of all lab samples for the duration of all assigned trials.
• Responsible for the completeness of documents managed in the electronic Trial Master Files (eTMF); performed ongoing reviews of eTMF to assure quality of the documentation filed and compliance with SOPs, GCP and ICH Guidelines.
• Supported internal eTMF audits for all assigned trials.
• Performed electronic Case Report Form (eCRF) review, query generation and resolution against established data review guidelines.
• Participated in data management activities, including but not limited to UAT, data cleaning, validation, and database lock procedures.
• Managed study drug shipments for all assigned sites.
• Attended meetings and reported on activities and resolutions.
• Communicated with vendors to deliver appropriate clinical supplies to sites and meet ongoing operational demands.

Responsible for monitoring of clinical trials, management and training of investigative sites in the US and Canada.

Responsibilities include:

• Traveled to investigative sites to conduct site qualification, initiation, interim monitoring and close-out visits.
• Monitored study progress to ensure compliance by maintaining contact with investigator and site staff on a weekly basis.
• Provided protocol training to ensure site is compliant with GCP and applicable regulations
• Performed quality review of site specific Informed Consent Form (ICF).
• Reviewed source documents and verified data in EDC.
• Reviewed data queries and listings and worked with study centers to resolve data discrepancies.
• Assessed safety reporting requirements for each study, ensuring proper documentation and notification procedures were followed consistently.
• Provided confirmation letters, follow up letters and monitor visit reports per monitoring plan
• Facilitated timely resolution of issues.
• Liaised with clinical investigator to identify, assess and resolve site performance, quality and compliance issues.
• Ensured sites had sufficient study supplies
• Attended Investigator meetings
• Collected and reviewed regulatory documents from clinical site to ensure all required documents are obtained, complete and in compliance with GCP and local regulations.
• Maintained Trial Master File (TMF) and investigator site files for the duration of the study.
• Responsible for in-house submission of regulatory documents to IRB/REB
• Assisted in file reviews and reconciliation process in preparation for audits and archival.
• Participated in meetings with sponsor representatives to discuss clinical study developments.
• Collaborated with cross-functional teams to successfully meet project timelines and deliverables.

Conducted site start up activities for all trials. The network included eight Principal investigators and five locations.

Responsibilities include:

• Completion of feasibility questionnaires, site regulatory package preparation and submission to CROs/Sponsor.
• Initial site IRB submissions in accordance with relevant regulations, SOPs and study specific procedures.
• Maintained and reviewed regulatory documents for the duration of the trial.
• Completed IRB continuing review reports for all active trials.
• Performed investigator file reviews pre and post monitor visits and addressed any outstanding issues with the site monitor.
• Developed and maintained protocol training records for all study staff.
• Ensured all trial ISFs were audit ready at all times.
• Tracked and manage CVs, MD license and GCP for all staff.
• Enter subject data into applicable EDC systems for all subjects.
• Responsible for QA of all study files prior to sponsor audits.
• Conducted weekly staff meetings.
• Assisted study coordinators and performed study coordinator duties when needed.
• Assisted with creation of site SOPs and source documents.
• Managed site when site manager was out of office.

• Managed daily operations and coordinated all study activities per protocol guidelines.
• Served as primary contact for participants, CROs and Sponsors on all assigned trials.
• Prepared and maintained regulatory documents for clinical trial submissions.
• Screened patient records, databases, and physician referrals to identify prospective candidates for research studies.
• Followed informed consent processes and maintained records.
• Performed procedures as outlined in the protocol, including EKGs, venipuncture and processing/shipping of laboratory specimens.
• Created source documents for all assigned trials.
• Maintained and monitored proper storage of study medication/supplies.
• Maintained accurate and up-to-date case report forms and source documents for traceability.
• Reduced study deviations by closely monitoring patient progress and promptly addressing any issues or concerns.
• Gathered, processed, and shipped lab specimens.
• Worked with principal investigator and CRA to facilitate daily trial activities and comply with research protocols.
• Ensured site readiness for audits and inspections by maintaining a well-organized, detailed, and accurate study documentation system.
• Participated in FDA and EMA audits.

• Directed patients to exam rooms, fielded questions, and prepared for physician examinations.
• Sanitized, restocked, and organized exam rooms and medical equipment.
• Documented vital signs and health history for patients in clinic and hospital environments.
• Performed medical records management, including filing, organizing and scanning documents.
• Served as primary contact for subjects and sponsors
• Performed EKGs, venipuncture and processing/shipping of laboratory specimens.
• Collaborated with Research Monitors in providing accurate, concise clinical data for individual trials.
• Coordinated and conducted subject visits per protocol.
• Maintained and monitored proper storage of study medication/supplies.