Yesenia Ramirez Email & Phone Number

Cypress, Tx, Us

Ctsu, Dan L. Duncan Comprehensive Cancer Center

Manage, direct, plan and schedule activities and programs for the regulatory departmentEstablish and enforce procedures that assure all trial teams and sites are fully compliant with all applicable laws, regulations, standard operating procedures (SOPs), and other applicable guidelinesDevelop and implement regulatory policies and procedures for the sites and the site Clinical Operations team; including managing and planning regulatory affairs compliance for industry sponsors and/or sitesManage the regulatory affairs between the organization for multiple clinical trials according to FDA and Good Clinical Practice (GCP) guidelines; for individual sites, studies, sponsors and/or other networksManage the relationships between industry partners and the FDA regarding regulatory compliance for the organization and managing regulatory audits of studies by sponsor/industry and governmental auditorsResolve key regulatory issues with Pharmaceutical Industry Partners and Government AgenciesDevelop and implement an approved archiving system for study specific regulatory documentation and correspondenceApprise management of important regulatory issues and obtains guidance when necessaryAttend network meetings, conference calls and monthly staff meetings as appropriateVisit strategic sites and provides training and mentoring as neededProvide proactive and creative recommendations on how to meet goals and handle identified deviationsResponsible for objective setting, performance management, education and training of the regulatory staff, including developing Lead Regulatory Affairs SpecialistsResponsible for implementing, managing, and refining departmental processes, and coordinating with clinical personnel around the conduct of research and client service issuesInitiate improvements, tools and forms to enhance the efficiency and the quality of the work performed on assigned projects

• Lead/manage regulatory submissions for 30-45 concurrent clinical trials from start-up to closeout• Collaborate with sponsor/CRO for central monitoring visits and ensure all queries are addressed for complete trial master filing• Train/mentor new regulatory team members on SOP’s and internal guidance, and provide regular training refreshers• Serve as SMO contact for investigator Conflict of Interest (COI) by reviewing potential COI, guide investigators on accurate disclosure, obtain sponsor approval, quarterly reporting to regulatory bodies, and aide in creation of COI mitigation plans• Create, implement and annually review relevant SOP’s, Work Instructions and controlled documents for consistency and adherence across study sites• Responsible for study TMF completeness, quality and inspection• Lead/manage regulatory submissions for 30-45 concurrent clinical trials from start-up to closeout• Collaborate with sponsor/CRO for central monitoring visits and ensure all queries are addressed for complete trial master filing• Train/mentor new regulatory team members on SOP’s and internal guidance, and provide regular training refreshers• Serve as SMO contact for investigator Conflict of Interest (COI) by reviewing potential COI, guide investigators on accurate disclosure, obtain sponsor approval, quarterly reporting to regulatory bodies, and aide in creation of COI mitigation plans• Create, implement and annually review relevant SOP’s, Work Instructions and controlled documents for consistency and adherence across study sites• Proactively identify and communicate the status of ongoing studies, identify risk mitigation strategies, associated action plans and issue resolution measures to ensure timely and on budget execution of clinical trial deliverables• Responsible for study TMF completeness, quality and inspection• Draft and revise informed consent forms

The Woodlands, Tx

Responsible for execution of clinical trials within the USOR network, including adherence to approved protocol, budget and contract. Communicate with sponsor/CRO throughout duration of the study. Communicate with sites and associated network operations team regarding project status. Oversee development and maintenance of USOR study tools (i.e. protocol specific flow sheets, clinical trial information sheets, training documentation) Implement research trials at the practice level and develop formats to ensure successful education of clinical research staff. Facilitates ongoing project training throughout the trial timeline. Serves as the study point of contact for all clinical research staff. All questions related to the protocol, billing, payout, monitoring issues, etc. are directed to the clinical trial manager.Responsible for outlining expectations to internal teams/sponsor/vendors to ensure successful study implementation. Review clinical trials for scientific merit and operational review for staff working in an outpatient community based setting. Review protocol procedures for standard of care vs. research related charges. Provide supporting team members with the information and contacts they need in order to complete tasks.Review project status with the physician disease program leadership. Provide the client monthly operational reports as well as clear direction on the study.Work closely with network operations managers and regional directors to ensure sites meet study expectations, including accrual, data entry and quality, and overall adherence to GCP and USOR SOPs.Review monitoring and auditor follow-up letters and monitors survey forms for quality indicators. Works with the regional staff and quality assurance team to facilitate quality improvement programs (plans of action) related to clinical trials.Responsible for submitting timely amendments and hold teams accountable to a timeline. Responsible for monitoring data completion and backlog.

Houston, Texas

- Manage Head and Neck Cancer Biorepository and Tissue Banking - Support investigators in appropriate planning for clinical trial coordination - Update and maintain CTMS information for head & neck cancer clinical trials- Identify eligible subjects and ensure appropriate informed consent of study participants- Ensure timely and accurate EDC completion and query resolution- Attend site monitoring visits and FDA audits and resolve outstanding issues- Draft and ensure timely submission of Serious Adverse Events

Houston, Texas

- As IACUC voting member, reviewed proposals and ensured approval of ethical animal research- Prepared and maintained all IACUC records and minutes as prescribed by regulatory bodies- Supported IACUC committees and served as point of contact for investigators and committee members- Reviewed and processed animal research protocols- Coordinated and served on semiannual program reviews, animal facility inspections and subcommittees- Organized and wrote program review report to OLAW for Institutional Official’s approval- Applied regulatory knowledge to resolve potential non-compliance by investigators

Houston, Tx

- Directed clinical trial protocols including data management of regulatory documents- Maintained investigators’ Trial Master Files (eTMF)- Gathered experience in overseeing hematology/oncology clinical trials by handling industry and cooperative National Cancer Institute (NCI) studies while collaborating with CRO’s from study start to finish- Efficiently handled clinical study timelines and submissions to multiple regulatory review committees, including institutional IRB and IBC, NCI Central IRB, and commercial IRB’s (Western IRB), VA R&D Committee, Data Review Committees and Protocol Review and Monitoring Committees- Coordinated and presided over pre-study initiation meetings to review logistics and facilitated negotiations for procedures to remove study obstacles and ensure continuity- Collected and submitted all study related documents to appropriate user, including Confidentiality Disclosure Agreements, feasibility forms, all essential documents, financial disclosures, and maintained delegation logs and communication trails- Ensured informed consent documents were accurate and included all required elements- Reviewed and approved study-related invoices and costs- Drafted and updated clinicaltrials.gov listings for investigator-initiated trials- Reviewed source documents for patient eligibility- Coordinated site qualification, monitoring and close-out visits with CRO- Ensured clear plan for pharmacy drug availability and transfer among multiple research sites

Houston, Tx

- Directed day-to-day operations of the IACUC and IBC Offices- Developed and implemented IACUC/IBC policies, guidelines, and administrative functions in accordance with regulations and accrediting agencies; ensured updates were reflected in institutional SOP’s- Supervised and trained research analysts to apply regulations and provide customer service to investigators- Assembled newly created Dual Use Research of Concern institutional committee and drafted institutional Policies & Procedures per NIH guidelines- Conducted annual orientation for new IACUC and IBC members to review regulations and responsibilities- Planned and implemented continuing education for IACUC and IBC committee members

Houston, Texas Area

- Served as IACUC and IBC member to review proposals and ensure approval of ethical animal research- Directed day-to-day operations of the IACUC and IBC Office- Prepared and maintained all IACUC/IBC records and minutes as prescribed by regulatory bodies- Developed and implemented IACUC/IBC policies, guidelines, and administrative functions in accordance with regulations and accrediting agencies- Supported IACUC/IBC committees and served as point of contact for investigators and committee members- Reviewed and processed animal research protocols- Assured regulatory issues were discussed and resolved, and documented discussions and controverted issues- Coordinated and served on annual/semiannual animal facility inspection teams and subcommittees for the IACUC- Applied regulatory knowledge to resolve potential non-compliance by investigators

Houston, Texas Area

(Homebased)- Served as regulatory coordinator for pediatric pulmonology clinical research team- Drafted and negotiated research study budgets- Routed and tracked clinical trial agreements through sponsored programs offices for contract execution- Reviewed and approved research invoices for payment- Initiated IRB initial submissions, amendments and annual renewals for program- Coordinated weekly team meetings to discuss ongoing clinical trials- Served as member of Pediatric Pulmonology Fellowship Committee and Pediatric Fellows’ College- Coordinated internal and external (ACGME) accreditation site visits, resulting in 5 year accreditation for postdoctoral fellowship program - Collaborated to establish and document curriculum for fellowship program with > 90% board passing rate- Coordinated fellowship interviews, credentialing and orientation- Maintained project management timelines to ensure each fellow completed requirements for board eligibility

Houston, Tx

- Supported IRB Committee and processed over 100 human subject protocols each month- Provided ethical and regulatory guidance to investigators and IRB members- Communicated IRB approval requirements, assessed PI response, and ensured adherence to regulations - Participated in IRB-sponsored education sessions- Reviewed informed consent forms to ensure elements of consent were described; suggested changes to PI’s- Reviewed full board and expedited protocols, and coordinated scientific reviewers throughout college- Ensured key ethical/regulatory issues were discussed at convened meetings- Drafted and documented IRB minutes and controverted issues