Luis Estrada Berrocal

Assigned as a Line Manager for MSD Guatemala.

Manage a group of 20 people assigned to MSD in the positions of Junior Monitors, Sr. CRAs, Regulatory Managers, Regulatory and Financial Assistants.

Ensure that personnel perform their responsibilities in accordance with policies, procedures, ICH, GCP and other regulatory statutory requirements, in addition to meeting 100% metrics requested by the company and assigned sponsor.

Schedule and review project tasks and lead the delivery of services to clients.

Responsible for resource management and resource forecasting to ensure project teams meet client needs and expectations and contractual expectations.

Assigned as a Sr.CRA for MSD.

Assigned to Clinical Trials in Guatemala, Honduras, Dominican Republic and Costa Rica in Therapeutic Republic such as HIV, Diabetes Mellitus, Oncology, Community Acquired Intrahospital Pneumonia, etc.

Implement and supervise the clinical trial to ensure that the sponsor's and investigator's obligations are met and that applicable local regulatory requirements and ICH-GCP guidelines are met.

Reviewing and verifying the accuracy of clinical trial data collected, either on-site or data collected, either on-site or remotely.

Assess the qualification of potential investigational sites, initiate clinical trials at investigational sites, instruct site personnel on the proper conduct of clinical trials, and close clinical trials at investigational sites.

Perform source document verification ,AEs, SAEs and query resolution.

Work closely with other members of the clinical team to facilitate the timely clinical team to facilitate timely resolution of clinical and/or clinical trial issues.

Provide periodic site status information to team members and trial management and update trial management tools.

• Managed patient recruitment, informed consent process and data entry to support trial objectives.
• Improved clinical trial efficiency by streamlining data collection and management processes.
• Played an instrumental role in driving enrollment success by collaborating closely with sites on recruitment strategies tailored to specific patient populations.
• Followed informed consent processes and maintained records.
• Assigned to Clinical Trials in Guatemala, Honduras, El Salvador, and Costa Rica in Therapeutic and Costa Rica in Therapeutic Areas such as Psychiatry, Oncology, Infectious Diseases, etc.
• Written and verbal communication skills including good command of English language. Organizational and problem-solving skills. Effective time and financial management skills. Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Implement and monitor the clinical trial to ensure that sponsor and investigator obligations are met and that applicable local regulatory requirements and ICH-GCP guidelines are complied with.
• Review and verify the accuracy of clinical trial data collected, either on-site or remotely.
• Assess the qualification of potential investigational sites, initiate clinical trials at investigational sites, instruct site personnel on proper conduct of clinical trials and close clinical trials at investigational sites.
• Perform source document verification ,AEs, SAEs and query resolution.
• Work closely with other clinical team members to facilitate timely resolution of clinical and/or clinical trial issues.
• Provide periodic site status information to team members and trial management and update trial management tools.

Responsible for 14 CRAs (7 Honduras, 5 Puerto Rico, 2 Costa Rica, 1 Dominican Republic.

Manage personnel in accordance with organizational policies and applicable regulations.

Participate in the selection and onboarding process of new clinical staff by reviewing candidates and participating in the interview process.

Ensure that staff have the appropriate materials, access to systems and training to carry out their job responsibilities. Oversee the implementation of the training plan, review of SOPs and training experiences. standard operating procedures and mentored training experiences.

Participate in the allocation of resources to clinical research projects by assigning staff to clinical trials appropriate to their experience and training.

Manage the quality of the clinical work of assigned personnel through periodic review and evaluation of the product.

Support the Philippine Offices in the training of 8 Monitors Junior. Manage staff in accordance with the organization's policies and applicable regulations.

Participate in the selection process and onboarding again clinical staff.

Carry out initial training of new staff together with the Human Resources and Learning training programs and Development. Ensure staff have the right materials, access to systems, and training to carry out their job responsibilities.

Supervise the implementation of the training plan, the review of standard operating procedures and the experiences of supervised training.

Participate in the allocation of resources to research projects assigning staff to clinical studies appropriate to their experience and training.

Manage the quality of the clinical work of assigned staff through regular product review and evaluation.

Ensure that staff meet defined workload, quality, and budget parameters. Act as a coach and mentor to junior and senior CRAs.

Monitor the progress of clinical trials.

Act as the primary liaison and primary contact for project-related issues.

Establish goals and strategies to direct activities.

Oversee the day-to-day activities of the CRA team.

Carrying out all types of tasks corresponding to the Monitoring activities (pre-study, initiation, during the study and closing). Support Junior CRA training. Phase III vaccine trial (1270 patients/4 sites) Phase II, Infectious Trial (50 patients/5 centers) Phase III, Infectious Trial (50 patients/ 3 centers Peru) Phase II, Infectious Trial (300 patients/1 center)

Carrying out all types of supervision and auditing tasks of centres (pre-study, start-up, intermediate and closing).

Manage and supervise the conduct of studies in the centres. Verification of source documents.

Resolution of Adverse Events, queries and notification.

Support Junior CRA. Phase II, infectious trial (7000 patients/ 1.

Carrying out all kinds of tasks corresponding to the Monitoring activities (pre-study, initiation, during the study and closing). Manage and supervise the conduct of studies in the centres. Verification of source documents.

Therapeutic Areas: Neurology - Migraine, Pediatrics and Adults Infectious Trials.

Multicenter studies in Guatemala, Costa Rica, El Salvador and Panama

• Assisted in drafting comprehensive research reports summarizing findings, conclusions, and recommendations for further action.
• Prepared and maintained regulatory documents for clinical trial submissions.
• Complied with research protocols by providing ongoing quality control audits.
• Maintained compliance with protocols covering patient care and clinical trial operations.
• Independent Clinical Trials Coordinator assigned to MSD Studies.