Rebeca Rojas Hernández

Perform site monitoring visits (initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.

Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.

Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.

Escalate quality issues as appropriate.

• Manage quality issues for blinded and unblinded studies from different therapeutic areas.
• Host and direct meetings with sponsor and functional leads for the discussion of site-related issues and creation of CAPAs to be implemented at site within sponsor timelines

Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.

Ensure copies/originals (as required) of site documents are available for filing in the Trial Master File (TMF), and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP, ICH, and local regulatory requirements.

Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.

Collaborate and liaise with study team members for project execution support as appropriate.

• Lead 25 CRAs for a Cardiovascular trial with 50 sites in the Country. Share relevant study communications, updates and requirements with CRA Team in order to standardize information shared and actions implemented at the sites.
• Lead of a high-risk site, CRA acts as the main point of contact between sponsor and the 12 CRAs assigned to site. Creation of CAPAs to be implemented with the site according to their procedures and sponsor requirements

Facilitated timely resolution of issues through effective communication with investigators, sponsors, and other vendors.

Monitored safety of human subjects and oversaw consent procedures to comply with local and federal regulations.

Liaised with clinical project leader and sponsor to effectively resolve study-related issues.

Developed strong relationships with investigators and site personnel to ensure ongoing compliance with study requirements.

Coach of two Associate-CRAs on sponsor specific tasks and systems

Named System Management Expert of Investigational Medicinal Product and Unblinded studies on July 2024

Named System Management Expert of Florence system on March 2025

Tutor of IQVIA CRA school for Investigational Medicinal Product Management workshop and Concur system.

Lead Project Support Coordinator for Oncology study

Completes review, coordination and compilation of files and other materials.

Distributes project documents and supplies

• International shipment of Media Storage Devices for site-specific Safety Reports (Austria, Netherlands, and Brazil)

Performs Central file reviews as assigned and documents findings in appropriate system.

Organizes and maintains correspondence files and other departmental records.

Analyzes and reconciles project documents, metrics and findings reports within specified timelines.

Provides clarification and resolution of findings related to documentation.

Composes, copies and distributes communications, reports, documents and forms.

Performs mass mailings and communications.

Assists with project management ad-hoc activities, producing reports or study plan editing.

Coordinates team conference calls and completes and distributes meeting minutes from internal/client/vendor meetings as applicable

Maintains a working knowledge of applicable GCPs, organization and client SOPs and/or protocol-related specifics through professional career development to ensure continued compliance.

Maintains a basic knowledge of project protocol and the ability to implement project plans with specific guidelines and accountable for meeting applicable project timelines in accordance with the contract.

Assists in ensuring audit ready files

• Develop and implement practical and timely solutions

Contributes to company, client and federal regulatory requirements/audit responses as needed

• Seek root causes, actively participated on Quality Event Investigation Meetings. Coordinated the QE closure corrective actions activities

Functions as an alliance level lead handling client integration and (e)TMF activities.

Acts as a mentor by demonstrating the role of an experienced Project Support Coordinator in the preparation and execution of all administrative functions

• Coaching of four Project Support Coordinators on Sponsor specific tasks and systems

Provides training to other functional team members and clients as requested

• Acts as main point of contact with Project Lead (PL)/Clinical Team Manager (CTM) and sponsor facing Project Support Coordinator
• Mentoring and oversight of the study Project Support Coordinators, management of time utilization, prioritization, organization, and rearrangement of the ongoing activities and main deliverables

Assists in training junior staff and supports departmental leadership in determining training needs.

Collaborated with researchers and scientists to design and execute the project titled Effect of Sphingosine-1-phosphate on VCAM-1 and ICAM-1 production in HMEC-1 cells.

Developed research protocols and procedures to produce accurate results.

Cell culture of HMEC-1 in liquid media under sterile conditions. Tracking of cell growth employing microscopy

Gathered, arranged, and corrected research data to create representative graphs and charts highlighting results for presentations.

Worked both independently and collaboratively in fast-paced laboratory environment.

Recorded experimental findings in laboratory notebook to analyze and interpret experimental findings.

Adhered to laboratory safety procedures to maintain compliance with quality control standards.

Lead Clinical Trial Coordinator for Oncology study.

Assisted with review, coordination and compilation of files and other materials.

Distributed project documents and supplies

• International shipment of a Media Storage Device for site-specific Safety Reports (Netherlands)

Used critical thinking skills to ensure tasks were proactively scheduled and fulfilled in line with project team needs

• Identify and escalate issues timely and accordingly

Processed and tracked study specific or department documents.

Performed Central and Site file reviews as assigned and documented findings in appropriate system.

Organized and maintained correspondence files and other departmental records.

Analyzed and reconciled project documents, metrics and findings reports within specified timelines.

Assisted with clarification and resolution of findings related to documentation.

Composed, copied, and distributed communications, reports, documents, and forms.

Provides systems support (e.g., CTMS, SharePoint Online, & eTMF).

Performs administrative tasks on assigned trials including but not limited to timely processing of documents sent to client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications with the Investigative sites and the Sponsor as needed, providing documents and reports to internal team members Maintained vendor trackers.

Provided accesses to company, client, and vendor systems

Assisted with project management ad-hoc activities, producing reports or study plan editing.

Coordinated team conference calls and completed and distributed meeting minutes from internal/client/vendor meetings as applicable

Maintains a working knowledge of applicable GCPs, organization and client SOPs and/or protocol-related specifics through professional career development to ensure continued compliance.

Assists in ensuring audit ready files

• Seek root causes, actively participated on Quality Event Investigation Meetings
• Used strong analytical and problem-solving skills to develop effective solutions

Contributes to company, client, and federal regulatory requirements/audit responses as needed.

Actively lead the preparation activities for an FDA inspection and EMA Mock inspection.

Coordination of the Local (Remote and On-Site Monitors) and Clinical Trial Coordinators Team audit preparation activities and reconciliations, creation of Study Specific guidelines for ensuring high-quality deliverables.

Performed mass mailings and site-specific communications to ensure audit readiness.

Resolution of Audit findings within the given timelines.

Granted support to Functional Leads with documentation for Project Delivery, produced reports and trackers for QA review and delivery with Sponsor/auditor.

Provides training to other functional team members and clients as requested

• Acts as main point of contact with Project Lead (PL)/Clinical Team Manager (CTM) and sponsor facing Clinical Trial Coordinator
• Mentoring and oversight of the study Clinical Trial Coordinators, management of time utilization, prioritization, organization, and rearrangement of the ongoing activities and main deliverables

Functions as an alliance level lead handling client integration and (e)TMF activities.

Acts as a mentor by demonstrating the role of an experienced Clinical Trial Coordinator in the preparation and execution of all administrative functions

• Coaching of three Clinical Trial Coordinator on Sponsor specific tasks and systems

Assists in training junior staff and supports departmental leadership in determining training needs.

Lead Clinical Trial Coordinator for Infectious Disease and Oncology studies.

Assisted with review, coordination and compilation of files and other materials.

Distributed project documents and supplies

Used critical thinking skills to ensure tasks were proactively scheduled and fulfilled in line with project team needs

• Supported the critical activities (Top Line Results Communication) for the study Data Base Lock (SPOT Award)

Processed and tracked study specific or department documents.

Performed Central, Country and Site file reviews as assigned and documented findings in appropriate system.

Analyzed and reconciled project documents, metrics and findings reports within specified timelines.

Assisted with clarification and resolution of findings related to documentation.

Attended Project Launch and Kickoff meetings and took meeting minutes.

Composed, copied, and distributed communications, reports, documents, and forms.

Performs administrative tasks on assigned trials including but not limited to timely processing of documents sent to client (e)TMF as assigned, performing (e)TMF reviews, performing mass mailings and communications as needed, providing documents and reports to internal team members Maintained vendor trackers.

Provided accesses to company, client, and vendor systems.

Coordinated team conference calls and completed and distributed meeting minutes from internal/client/vendor meetings as applicable.

Assists in ensuring audit ready files.

Contributes to company, client, and federal regulatory requirements/audit responses as needed

• Actively lead the activities for an FDA Mock inspection (SPOT Award) and PPD Audit
• Resolution of Audit findings within the given timelines

Provides training to other functional team members and clients as requested.

Functions as an alliance level lead handling client integration and (e)TMF activities.

Acts as a mentor by demonstrating the role of an experienced Clinical Trial Coordinator in the preparation and execution of all administrative functions.

Single-channel and multi-channel pipette verification and protocol design for the Genomic Diagnostic Laboratory.
Developed proposals for testing and Calibration laboratory design.
Developed algorithms in R at the Bioinformatics Department.
Collaborative work in multidisciplinary teams.